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  • OSIRIS is an investigator-led, proof-of-concept Phase 2 study of orismilast for the treatment of mild to severe hidradenitis suppurativa (HS)
  • HS is a scarring inflammatory skin disease with significant unmet treatment need
  • Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of psoriasis and atopic dermatitis

Hellerup, Denmark, 14 October 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced the enrollment of the first patient in OSIRIS, a Phase 2, open-label, proof of concept study of an oral tablet formulation of orismilast in adult patients with mild, moderate and severe HS. The primary objective of OSIRIS is to explore evidence of efficacy of oral orismilast in the treatment of patients with HS for up to 16 weeks. Orismilast is currently in Phase 2 of clinical development for various inflammatory skin diseases, including psoriasis and atopic dermatitis.

The investigator-initiated, single-site OSIRIS study is led by Professor Gregor B. Jemec, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark. Dr. Jemec is at the global forefront of HS research, contributing significantly to the definition and management of the disease with more than 200 publications so far.

Professor Gregor B. Jemec said:
“Hidradenitis suppurativa is an autoimmune systemic skin disease. It causes wide-spread inflammation and scarring causing serious detrimental effects on the quality of life of patients. Yet it has only limited treatment options, that often provide only temporary symptomatic relief. There is a significant and urgent unmet need for an effective therapy. We are therefore very pleased to be able to enroll the first of 24 patients in the study and hope that orismilast as an innovative oral approach will demonstrate benefit in the management of this devastating illness.”

Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“While HS may be a niche indication, it has serious consequences for the patient. Due to chronic pain, drainage, and malodor associated with lesions, the condition imposes a significant burden on patients’ quality of life. With limited treatment options today, we are eager to support Gregor B. Jemec and his team at Zealand University Hospital investigating the potential of orismilast for becoming a safe and efficient, first in class, oral treatment for HS.”

About the OSIRIS Phase 2 study
OSIRIS is a phase 2, open-label, single-centre, prospective, single arm, investigator-initiated proof of concept study investigating the efficacy and safety of an oral tablet formulation of orismilast applied twice daily for up to 16 weeks in adult patients with mild, moderate, and severe HS. The clinically relevant primary endpoint is percent change from baseline in abscesses and nodules count at week 16 of treatment. The study will enroll 24 adult patients (men and women); 8 with mild, 8 with moderate, and 8 with severe HS.

About orismilast
Orismilast is a potent and selective PDE4 inhibitor. PDE4 inhibition works high in the inflammation cascade and as such have the potential to inhibit many autoimmune pathways involved in dermatologic diseases such as HS. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical approved and marketed. The selectivity of orismilast for PDE4 subtypes B and D has preclinically resulted in improved anti-inflammatory potency. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis.

UNION therapeutics has two product candidates with orismilast in its clinical stage pipeline: UNI50001, an oral PDE4 inhibitor currently investigated for the treatment of psoriasis, atopic dermatitis and HS; and UNI50002, a non-steroidal topical PDE4 inhibitor currently investigated for the treatment of atopic dermatitis.

About HS
HS is a chronic, inflammatory skin disease which results in painful inflammation of the hair follicles, most notably in the armpit and genitalia regions. The clinical hallmarks of the disease include very painful inflammatory nodules, boils or abscesses that typically open and release odorous inflammatory fluids. HS patients suffer primarily from pain and significant discomfort resulting from the constant formation of pus, often requiring the use of bandages and diapers, resulting in social isolation. Patients are often stigmatized by these symptoms. Not surprisingly, HS severely and adversely affects patients' quality of life and is associated with an increased overall mortality rate due to cardiovascular disease and completed suicides.

HS is an immune-mediated disorder with an unknown etiology, with many immune pathways activated - expectedly requiring a broad anti-inflammatory approach to achieve good efficacy. Treatment for HS patients typically includes topical, oral or intravenous antibiotic treatment, which often provide only temporary symptomatic relief. In some cases, patients also undergo different types of surgery.

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries
UNION therapeutics A/S

Sarah Toft-Jørgensen, Director of Communications and IR
+45 5385 3044
[email protected]

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

 

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  • Orismilast is a potential best-in-class PDE4 inhibitor in Phase 2 clinical development for the treatment of atopic dermatitis, psoriasis, and hidradenitis suppurativa
  • Innovent will be granted exclusive rights to research, develop and commercialize orismilast in China (including Mainland China, Hong Kong, Macau and Taiwan)
  • UNION will receive USD 20 million upfront and be entitled to receive additional milestone payments of up to USD 247 million as well as tiered royalties on sales of orismilast in China


Hellerup, Denmark, San Francisco, U.S. and Suzhou, China, 28 September 2021 – UNION therapeutics A/S (‘UNION’), a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, and Innovent Biologics (HK) Limited, a subsidiary of Innovent Biologics, Inc. (HKEX: 01801, ‘Innovent’), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that they have entered into a strategic collaboration and license agreement for the development and commercialization of orismilast in China.

Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including participating in and recruiting Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of USD 20 million and is further entitled to receive up to USD 247 million in milestone payments as well as tiered royalties on sales of orismilast in China. UNION will retain global rights for orismilast outside of China.

In China there are approximately fifty million patients suffering from atopic dermatitis and six million patients suffering from psoriasis, and their prevalence is rising with changing lifestyles. Current standard of care treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in efficacy, safety or route of administration, presenting significant unmet clinical needs. In Phase 2a clinical studies, orismilast has demonstrated potential best-in-class profiles in these conditions with a combination of improved efficacy and tolerability, and could be well positioned to address the unmet needs of these patient populations.

Dr. Yongjun Liu, President of Innovent, said:
We are very pleased to enter a collaboration with UNION. We have been impressed with our partner’s capability to advance the global development of orismilast and we are excited to help bring orismilast to patients in China. This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio. Innovent is proud to be an ideal partner for worldwide biotech and pharmaceutical companies in terms of accelerating the development and commercialization progress of novel assets to benefit a broader patient population.”

Kim Kjøller, Chief Executive Officer of UNION therapeutics, said:
“We are excited to enter into this strategic collaboration with Innovent, whose deep insights and presence in China make them an ideal partner to bring orismilast to Chinese patients. We are impressed by Innovent’s track record of international partnering, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the best-in-class potential of orismilast and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is core to our strategy of maximizing the value of our product candidates, and we are therefore excited to enter this collaboration with an internationally recognized partner.”

About orismilast
Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best- or first-in-class treatment option in both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to result in an attractive therapeutic window, i.e., the combination of improved efficacy and tolerability, compared to other PDE4 inhibitors.  UNION has two product candidates with orismilast in Phase 2 clinical development: UNI50001, an oral PDE4 inhibitor investigated for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast investigated for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical currently approved and marketed.

About Innovent 
Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing in China, 1 asset’s NDA under NMPA review, sintilimab’s Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics.

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team combining biotech entrepreneurs and senior pharma executives, with a collective track record of completing more than fifteen product approvals. Read more at www.uniontherapeutics.com

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
[email protected]
+45 2381 5487

Media enquiries in Denmark
Point Communications
Jørgen Fischer Ravn
[email protected]
+45 2030 3903

International media enquiries
Consilium Strategic Communications
Matthew Cole
[email protected]
+44 (0)7593 572 720

 

 

Innovent Biologics, Inc.
Media:
[email protected]
+86 512-6956 6088

Investors:
[email protected]
+86 512-6956 6088

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Hellerup, Denmark, 12 July 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage pharmaceutical company focused on immunology and infectious diseases, today announced that Gitte Aabo, CEO of GN Hearing A/S, and Arthur Higgins, Senior Advisor to Blackstone Private Equity Group, have been elected to the Board of Directors of UNION. Arthur Higgins has been appointed Deputy Chairman of the Board.

Stig Løkke Pedersen, Chairman of the Board of Directors of UNION, says:
“With their impressive track records, Gitte Aabo and Arthur Higgins are very experienced life science professionals with long executive careers at the highest level in the healthcare industry, spanning from innovation and startup to chief executive positions of large, global companies, directorships, deal-making and financing. Thanks to their comprehensive leadership experience from large and complex organizations, they will provide significant value to the board’s work regarding strategy, governance, and company processes. They complete the board’s competences, and I very much look forward to working with Gitte and Arthur on UNION’s exciting journey.”

Rasmus Toft-Kehler, Co-Founder of UNION and Chief Operating Officer, says:
“I am proud of UNION’s ability to attract very strong board members with proven track records, international network and strategic vision, who can support our ambition to build a sustainable and innovative pharmaceutical company. Gitte Aabo brings deep insights in dermatology from LEO Pharma and relevant experience as the current CEO of a large listed global healthcare leader. Arthur Higgins knows the mechanics of leading a pharmaceutical company inside out, and he has extensive deal making experience. On top of that, they are amazing people, who I am sure will deliver substantial value to UNION.”

Gitte Aabo is the Chief Executive Officer at GN Hearing (NASDAQ: GN), one of the global leaders in hearing aid innovation. Prior to this, she was President & Chief Executive Officer of LEO Pharma. Gitte Aabo is also a member of the Committee of Directors of Danmarks Nationalbank (the Danish National Bank), and a board member of ALK-Abelló A/S and HIMPP A/S. Gitte Aabo has extensive global leadership experience from the life science industry and a deep understanding of dermatology, marketing and capital markets. Gitte Aabo holds an M.Sc. in Business administration from Copenhagen Business School.

Arthur Higgins is a Senior Advisor to Blackstone Private Equity Group and Board member at Ecolab (NYSE: ECL) and Zimmer Biomet (NYSE: ZBH). Previously, Arthur Higgins was Chief Executive Officer of Bayer HealthCare AG as well as Chairman of the Bayer HealthCare Executive Committee and Enzon Pharmaceuticals. He also served as President and Chief Executive Officer and a member of the board of directors of Assertio Therapeutics, Inc. Through extensive leadership experience at large healthcare companies in both the United States and Europe, Arthur Higgins will provide UNION with deep knowledge of the global pharmaceutical markets and strategies for developing, marketing and transacting pharmaceutical products. Arthur Higgins holds a B.Sc. in Biochemistry from Strathclyde University and is based in the U.S.

Contacts
UNION therapeutics A/S

Morten Boesen, Chief Financial Officer
+45 2381 5487 – [email protected]

Media enquiries
Point Communications

Jørgen Fischer Ravn
+45 2030 3903 – j[email protected]

About UNION therapeutics
UNION therapeutics is a privately held, multi-asset, clinical stage pharmaceutical company focused on immunology and infectious diseases. The company currently has seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team combining biotech entrepreneurs and senior pharmaceutical executives, with a track record of developing, launching and commercializing more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

 

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  • Dr. Per Cantor, MD, DMSci, appointed as new Chief Medical Officer
  • Mr. Eckhard Niemeier appointed as Chief Business Officer
  • Mr. Mads Jellingsø promoted to Chief Commercial Officer


Hellerup, Denmark, 31 May 2021 – UNION therapeutics A/S, a privately held, multi-asset, clinical stage, pharmaceutical company focusing on infectious and inflammatory diseases, announces onboarding of Dr. Per Cantor, MD, DMSci, as the Chief Medical Officer, effective as of 1 April 2021. Also, as of 1 June 2021, Mr. Eckhard Niemeier, MSc Biotechnology, will join UNION as Chief Business Officer. At the same time, Mr. Mads Jellingsø is promoted to Chief Commercial Officer from his current position as VP, Commercial and Medical Affairs.

Per Cantor provides significant drug development expertise to UNION
Dr. Cantor brings over 30 years of experience and several significant accomplishments from the life science industry to UNION, where he will assume overall responsibility for UNION’s development programs across infectious and inflammatory diseases. Dr. Cantor has served as SVP of Clinical and Preclinical R&D at Ferring from 2006-2020, the last two years as Chief Scientific Officer in China, where he expanded the Ferring R&D organization and in collaboration with the Chinese Academy of Sciences established the Ferring Institute of Reproductive Medicine in Beijing with more than 100 scientists. Prior to Ferring, Per Cantor was 15 years at Eli Lilly in both Europe and at the Lilly Research Laboratories in the US, leading major clinical development programs mainly within endocrinology and Women’s Health.

With his experience from every step of the R&D process, all the way from drug discovery, pre-clinical and clinical development, regulatory approval, product launch, and Life Cycle Management, Dr. Cantor will play an important role in advancing the pipeline of UNION.

Per Cantor said: “UNION has a strong clinical pipeline with the potential to make a huge difference to patients in major therapeutic areas. I am impressed with the company’s capabilities within medical and pharmaceutical innovation, taking a holistic and innovative view on the molecules’ potential across therapeutic areas, and look forward to contributing with my own experience of bringing novel drugs all the way to the patient.

Eckhard Niemeier to advance strategic partnerships
Working almost 20 years with all stages of business development in the life science industry, Mr. Niemeier will be focusing on bringing UNION’s portfolio management to the next level. Eckhard Niemeier will join UNION from a position as SVP, Head of Business Development & Portfolio Management at Pieris Pharmaceuticals (Nasdaq:PIRS), where he was responsible for all business and corporate development activities including establishing strategic partnerships with AstraZeneca, Roche/Genentech, Seagen and Servier. Prior to joining Pieris, Eckhard Niemeier held senior business development positions in Gruenenthal GmbH and MorphoSys AG and spent more than five years with McKinsey & Co.

Eckhard Niemeier said: “UNION’s pipeline has been significantly expanded and matured over the last couple of years, and I look forward to contributing to further advancing it towards the multiple potential near-term value inflection points lying ahead. I am excited to be joining the company at such an important time and also look forward to exploring partnerships and other portfolio opportunities as an integrated part of UNION’s strategy.

Mads Jellingsø promoted to Chief Commercial Officer
In his role as Chief Commercial Officer, Mads Jellingsø will assume the broader commercial responsibility for UNION’s pipeline, including the development and execution of road maps for commercialization of lead drug candidates. Mads joined UNION in 2018 from Novo Nordisk.


UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries
Jørgen Fischer Ravn, Point Communications
+45 2030 3903
j[email protected]


About UNION therapeutics A/S
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working on two complementary chemistry classes spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an international team combining biotech entrepreneurs and senior pharma executives with a track record of more than 15 marketed drugs. Read more at www.uniontherapeutics.com

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  • The Lancet Regional Health - Europe has published the results of UNION therapeutics’ phase 1 study of inhaled and intranasal niclosamide products (UNI91103 and UNI91104)
  • The study endpoints were to assess the safety profile and the pharmacokinetic profile of niclosamide when administered as a nasal spray and as an inhalation product (nebulizer)
  • The study was placebo-controlled and conducted in healthy volunteers
  • No adverse effects were identified, paving the way for further investigation in COVID-19 patients
  • On the basis of these results UNI91103 has been selected as the first intervention of the PROTECT-V study, which recently received UK Urgent Public Heath prioritization


Hellerup, Denmark, April 6, 2021 – UNION therapeutics A/S (UNION) announced today that the results of a phase 1 study of inhaled and intranasal niclosamide (UNI911) have been published by The Lancet Regional Health – Europe (LINK). With no serious adverse effects reported, the study showed a strong safety profile of inhaled and intranasal niclosamide which was the primary endpoint for the trial.

The promising safety and pharmacokinetic results for inhaled and intranasal niclosamide have opened the doors for further investigation, and will now be tested as a potential treatment (UNI91104) and prophylaxis (UNI91103) for COVID-19. Niclosamide was shown by Institut Pasteur to have a 40-fold better potency than remdesivir against SARS-CoV-2.

Local administration of niclosamide prompts new options for the treatment of COVID-19

Professor Vibeke Backer, pulmonologist at the Center for Physical Activity Research, at Rigshospitalet, Copenhagen, served as principal investigator for the phase 1 study. Professor Backer has taken the lead on the Lancet Regional Health Europe paper.

“UNI91103 and UNI91104 are exceptional because the products are administered locally by inhalation and intranasal administration. Hence, the poor bioavailability of niclosamide is addressed, enabling a high drug concentration in the area from which the COVID-19 infection otherwise starts to spread. In this way, inhaled drugs have been crucial in the management of other respiratory conditions such as asthma. Niclosamide is a relevant and important product that holds great potential for COVID-19, and it is rewarding to see this important data published in a peer-reviewed journal,” Dr Backer said.

The phase 1 trial described in the publication was randomized, placebo-controlled, double-blinded, multi-ascending dose, and was conducted in 44 healthy volunteers, of which 34 were assigned to UNI911 and 10 to placebo across five cohorts.

The trial was conducted with DanTrials at Bispebjerg Hospital, Copenhagen, backed by experts from Rigshospitalet and supported financially by the Innovation Fund Denmark.

Local administration of niclosamide to the nasal cavity and the lungs was well tolerated

The phase 1 trial met all its endpoints and demonstrated that the concentrated niclosamide solution of UNION therapeutics is well tolerated when administered via the intranasal and inhaled route. The study results demonstrated a dose-proportional pharmacokinetic and showed no signs of systemic accumulation of the drug in the blood.

“With these promising results for safety and tolerance, the COVID-19 products of UNION therapeutics are gaining substantial interest from platform trials across the world,” said Professor Morten Sommer, Chief Scientific Officer at UNION therapeutics.

A promising prophylactic option for vulnerable patients

UNION therapeutics recently announced that UNI91103 will be tested in kidney patients, a particularly high-risk patient population. Led by Cambridge University and funded by among others Kidney Research UK, the PROTECT-V study is set to determine if UNI91103 could work as a preventive treatment for kidney patients who may not benefit sufficiently from vaccinations alone.

“Finding effective agents for treatment and prophylaxis is crucial for our ability to manage COVID-19 infection. We identified niclosamide as a promising option, and we look forward to testing it in this very critical patient population,” said Dr Rona Smith in connection to the announcement of the PROTECT-V trial. Dr Smith, who is leading the study, is senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke’s Hospital.   

The PROTECT-V trial recently received Urgent Public Health Prioritization from the UK government ensuring rapid roll out across the UK.

The Lancet Regional Health - Europe is a regional edition of the Lancet that focuses on research conducted in the European Region.

Sources
1: Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf


About UNI91103 and UNI91104
Recent studies undertaken by the Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as one of the most potent inhibitors of SARS-CoV-2; the virus causing COVID-19 based on in vitro studies. Niclosamide has the potential to become a truly differentiated treatment of COVID-19, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. UNION has more than six years of preclinical and clinical experience with niclosamide and has utilized these insights to advance a battery of potential niclosamide-based treatments for COVID-19. UNI91103 and UNI91104 are two products developed by UNION based on a proprietary salt form and formulation of niclosamide to be administered locally to the respiratory tract. By delivering niclosamide directly to the lungs and the nasal cavity UNI91103 and UNI91104 addresses the challenges related to low bioavailability of niclosamide administered orally.

About UNION therapeutics A/S
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The Company is working on two complementary chemistry classes spanning immunology and microbiology, with multiple candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and is managed by an experienced international team. For more information, please visit: www.uniontherapeutics.com.

 

Contacts

UNION therapeutics
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: [email protected]

JW Communications

Julia Wilson
Tel: +44 781 8430877
Email: [email protected]

 

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