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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: morten.boesen@uniontherapeutics.com

JW Communications

Julia Wilson
Tel: +44 781 8430877
Email: juliawilsonuk@gmail.com

 

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Hellerup, Denmark, March 29, 2021 – UNION therapeutics A/S (UNION) today announced that the National Institute for Health Research (NIHR) in the UK has granted Urgent Public Health (UPH) prioritization to the PROTECT-V trial – a platform study investigating UNION’s niclosamide-based treatment candidate for COVID-19 in kidney patients.

Clinical trials granted UPH prioritization by the NIHR are deemed critically important in the fight against COVID-19 and will thus receive infrastructure support allowing expedited recruitment for the study. NIHR is an entity under the Department of Health & Social Care of the UK government.

UPH prioritization will enable streamlined site set up across the UK, and facilitate rapid patient recruitment as a result of NIHR resource and clinical research network support being available.

“We are pleased that our COVID-19 program has achieved this important recognition through the UPH prioritization of the PROTECT-V study as it paves the way for a faster and more efficient conduct of the trial,” said UNION co-founder, Professor Morten Sommer.

“The PROTECT-V trial is testing our product, a niclosamide-based nasal spray (UNI91103), in kidney patients, who may require additional protection from COVID-19 in addition to vaccination. Considering the medical needs within this high-risk patient group, it is vital that the trial will be able to roll out in an expeditated manner,” Professor Sommer concluded.

The PROTECT-V trial is led by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge and involves researchers and patients from across the UK.

About UNI91103
UNI91103 is a niclosamide based nasal spray in development for prophylaxis and treatment of COVID-19. SARS-CoV-2, the virus causing COVID-19, has been found to replicate most rapidly in nasal epithelial cells, and the sinonasal tract is thought to be an important site for infection as well as transmission. Niclosamide has been identified as a potent inhibitor of SARS-CoV-2 and has been demonstrated to prevent fatal outcomes in a murine challenge model of COVID-19 when administered intranasally. UNI91103 nasal spray is in development as a stand-alone product as well as in combination with UNION therapeutics’ inhalation treatment product (UNI91104).

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: morten.boesen@uniontherapeutics.com

JW Communications

Julia Wilson
Tel: +44 781 8430877
Email: juliawilsonuk@gmail.com

 

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  • UNI91103 is a nasal spray delivering niclosamide - a potent inhibitor of SARS-CoV-2 with in-vitro potency >40x higher than remdesivir - to the nasal cavity
  • UNI91103 has been selected as the first agent to be trialed in a study by UK investigators
  • If successful, data generated will be used for registration of the product
  • The study will include approx.1,500 kidney patients to assess if UNI91103 can prevent patients from contracting symptomatic COVID-19 and / or reduce serious illness and death from the infection
  • Kidney patients are considered a high-risk patient population that may not respond well to vaccination
  • Niclosamide has been demonstrated to prevent fatal outcomes in an animal model of COVID-19 when administered intranasally1

 

Hellerup, Denmark, February 22, 2021– UNION therapeutics A/S (UNION) has been selected by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge to trial UNI91103 (intranasal niclosamide) as a prophylactic treatment of COVID-19 in kidney patients, a vulnerable and high-risk patient population.

UNION has recently announced the expansion of its clinical program for COVID-19 with a niclosamide based nasal spray (UNI91103) to prevent and treat SARS-CoV-2 infection among people at risk. Kidney patients, in particular those on dialysis, are considered a particularly vulnerable patient population.

Following approval by the Medicines and Healthcare products Regulatory Agency (MHRA), the University of Cambridge has commenced recruitment to the PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion (PROTECT-V) trial.

A prophylactic treatment for vulnerable patients
“Niclosamide, the active ingredient of UNI91103, was recently identified as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, and is being developed by UNION for prevention and treatment of COVID-19,” says UNION co-founder, Professor Morten Sommer2.

Studies have documented that SARS-CoV-2 replicates most rapidly in the nasal epithelial cells and suggest that initial replication of the virus in the nasal cavity then leads to infection of the lungs2. When administered to the nasal cavity prior to exposure to SARS-CoV-2, UNI91103 would prevent the virus from establishing in the nasal cavity and spreading to the lungs. 

“For high-risk patient groups such as dialysis patients, patients who have had a kidney transplant, and patients with auto-immune diseases requiring immunosuppressive medications, COVID-19 can be very serious. In fact, one in five kidney patients receiving dialysis in hospital or who have a kidney transplant, who tested positive for the virus, died within four weeks,” explains Professor Morten Sommer3.

The fastest route to benefit patients
Funded by LifeArc, Kidney Research UK, the Addenbrooke’s Charitable Trust, UNION therapeutics and further supported by the NIHR Cambridge Biomedical Research Centre, the clinical trial is expected to enroll at least 1,500 high-risk subjects. Initially, trial participants will be randomised to receive either a placebo drug or UNI91103, both provided by UNION therapeutics, in addition to their standard of care.

LifeArc has made £27m available to support the global effort against COVID-19, of which £10m has been given to repurpose existing medicines.

“Repurposing already available drugs or those in the late stage of development offers the fastest route to bring benefit to patients at this critical time,” says LifeArc CEO, Melanie Lee.

A promising option
The trial, led by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, involves researchers and patients from across the UK.

Dr Rona Smith, who is leading the UK study, is senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke’s Hospital, says:

”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.”

“The vaccine is a huge step forwards, but we know that the patients enrolled in this study may make less robust vaccine responses due to their underlying condition or treatment. Niclosamide may provide further protection against COVID-19 that doesn’t rely on the immune system mounting a response,” Dr Smith adds.  

A persistent need for treatment and prevention
Currently a number of trials are taking place that are searching for an effective COVID-19 preventative treatment, but patients with impaired kidney function are largely excluded, despite being so vulnerable to the disease.

“Despite recent advancements with COVID-19 vaccines, UNION foresees a persistent need for prevention and treatment products targeting COVID-19. We are humbled and grateful for this extraordinary opportunity and look forward to collaborate with the PROTECT-V team to offer new prophylactic treatment options for some of the most vulnerable patients,” says Kim Kjøller, CEO of UNION, and elaborates:

“The reason why this particular patient group may not respond well to vaccines is due to a low serological response caused by a weak immune defense system. The immune system of these patient groups is weak because of their illness and/or because of the treatment they are receiving. This is why the mortality rates among high-risk patients are so devastatingly high. At UNION we see an urgent need for contributing a potential solution to these patient groups as the global vaccination roll-out might not be the answer for several patient groups at risk.”  

Sources
1. Brunaugh et al. BiorXiv 2020, DOI: 10.1101/2020.09.24.310490
2. Jeon et al. AAC 2020, DOI: 10.1128/AAC.00819-20
3. Renal Registry, UK

For further information
Morten Boesen
Chief Financial Officer
Phone: +45 2381 5487
Email: info@uniontherapeutics.com
Website: www.uniontherapeutics.com

Marie-Louise Jersin
Communications Manager
Phone: +45 3049 4957
Email: mlj@szpirt.com

About UNION:
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 across immunology and microbiology and has multiple candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced, international team of pharmaceutical executives and biotech entrepreneurs. For more information please visit www.uniontherapeutics.com.

About UNI91103
UNI91103 is a niclosamide based nasal spray in development for prophylaxis and treatment of COVID-19. SARS-CoV-2, the virus causing COVID-19, has been found to replicate most rapidly in nasal epithelial cells, and the sinonasal tract is thought to be an important site for infection as well as transmission. Niclosamide has been identified as a potent inhibitor of SARS-CoV-2 and has been demonstrated to prevent fatal outcomes in a murine challenge model of COVID-19 when administered intranasally. UNI91103 nasal spray is in development as a stand-alone product as well as in combination with UNION therapeutics’ inhalation treatment product (UNI91104).

About Kidney Research UK
As the largest kidney research charity in the UK, nothing is going to stop us in our urgent mission to end kidney disease. We’re here to be heard, to make a difference, to change the future. This is a disease that destroys lives. It must be stopped.

Over the past 60 years, our research has made an impact. But the incidence of kidney failure is rising, as are the factors contributing to it, such as diabetes and obesity. Today, we are more essential than ever. Kidney disease affects three million people in the UK, treatments can be gruelling and currently there is no cure. Only research will end this, and we are the ones to do it.

Find out more about our work: www.kidneyresearchuk.org

About LifeArc
LifeArc is a self-funded medical research charity. Our mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients. We have been doing this for more than 25 years and our work has resulted in a diagnostic for antibiotic resistance and four licensed medicines.

Our success allows us to explore new approaches to stimulate and fund translation. We have our own drug discovery and diagnostics development facilities, supported by experts in technology transfer and intellectual property who also provide services to other organisations. Our model is built on collaboration, and we partner with a broad range of groups including medical research charities, research organisations, industry and academic scientists. We are motivated by patient need and scientific opportunity. Two funds help us to invest in external projects for the benefit of patients: our Philanthropic Fund provides grants to support medical research projects focused on the translation of rare diseases research and our Seed Fund is aimed at start-up companies focused on developing new therapeutics and biological modalities. Find out more about our work on www.lifearc.org or follow us on LinkedIn or Twitter.

About Addenbrooke’s Charitable Trust (ACT)
Registered charity number: 1170103

Our purpose is to raise funds to make Addenbrooke’s and The Rosie hospitals even better through improved patient care that allows more people to be diagnosed quicker and more accurately, to get the treatment they need in environments that support health, and to recover more quickly or get the support that they need over and above what would be possible through NHS funding alone. With the help of many generous supporters, we provide funds so that your local hospitals can offer the very best care day after day, year after year.
For further information about Addenbrooke’s Charitable Trust’s work visit www.act4addenbrookes.org.uk or follow us on Twitter @ACTcharity.

About NIHR Cambridge Biomedical Research Centre
Based within the most outstanding NHS and University partnerships in the country, the Biomedical Research Centres are leaders in scientific translation. Located on the Cambridge Biomedical Campus, they receive substantial levels of funding from the National Institute for Health Research (NIHR) to translate fundamental biomedical research into clinical research that benefits patients and they are early adopters of new treatments.

 

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Hellerup, Denmark, February 9, 2021 - UNION therapeutics A/S (“UNION”), a privately held, clinical stage pharmaceutical company, today announced the completion of a 155m DKK financing round from a group of existing and new investors.

The proceeds enable accelerated development of UNION’s clinical programs, and in particular offers an opportunity for UNION to support international patient studies for which UNI91103 (nasal spray) and UNI91104 (inhalation treatment) have been invited by government sponsored COVID-19 platform trial committees.

Morten Boesen, Chief Financial Officer of UNION commented: “UNION has experienced tremendous growth and advancements in our clinical pipeline during 2020. With the selection into international COVID-19 patient studies, UNION is entering a new stage of development. We are honored and proud to support these studies and the development of treatment options for COVID-19 patients.”

Rasmus Toft-Kehler, Co-founder and Chief Operating Officer, further added; “The UNION team successfully advanced two drug development programs from idea to registration studies in 2020 and both team and momentum has continued to rapidly build as we entered 2021. With additional funds available, Dr. Kim Kjoeller in place as our new CEO, and four clinical product candidates in mid- to late stage development, UNION is set for an exciting 2021.”

About UNION:
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 and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA. For more information please visit www.uniontherapeutics.com.

 

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  • Orismilast is a next generation oral PDE4-inhibitor with an improved therapeutic window compared to other PDE4-inhibitors
  • Oral orismilast (UNI50001) has demonstrated proof of concept in patients living with plaque psoriasis and indicated “best-in-class” potential
  • PDE4-inhibition is a validated pharmacological target published for a broad range of inflammatory indications1
  • The improved therapeutic window of orismilast suggests potential for use in a number of inflammatory conditions, which have so far been limited by the typical narrow therapeutic window of PDE4-inhibitors


Hellerup, Denmark, January 7th, 2021 – UNION therapeutics A/S (UNION) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults.

A potential game-changer for people living with severe skin conditions
With the IND approval, UNION is granted permission to advance oral orismilast into Phase 2b trials in humans with moderate to severe plaque psoriasis to evaluate the safety and efficacy of orismilast. 

“Orismilast is a next generation PDE4-inhibitor with an improved therapeutic window compared to earlier oral PDE4 inhibitors, supporting the opportunity to achieve improved efficacy while maintaining good tolerability. It holds the potential to become a best-in-class treatment and a game-changer for psoriasis patients. Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. Oral orismilast would therefore offer an efficacious and patient-friendly treatment,” says UNION co-founder Professor Morten Sommer.

“Further, PDE4-inhibition is a well-documented pharmacological target for a number of other inflammatory indications, and we look forward to advancing our clinical research to realize the full potential of orismilast for the benefit of the millions of patients living with inflammatory conditions globally,” adds Professor Sommer.

One step closer to a novel treatment
Psoriasis is a common inflammatory skin condition involving 2–4% of the global population. It is clinically characterized by erythematous and scaly plaques that persist throughout life in variable severity.

”Plaque psoriasis is associated with an increased risk of developing severe comorbidities such as psoriatic arthritis, cardiovascular disease, metabolic syndrome, overweight/obesity, inflammatory bowel disease, and depression - all resulting in a substantial impact on the quality of life2”, says Dr. Kim Domela Kjoeller, CEO of UNION. He continues:

“With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

The trial design of the planned Phase 2b study will be a parallel-group, randomized, dose-ranging, double-blinded, four-armed study to evaluate the safety and efficacy of orismilast tablets compared with placebo in adults with moderate-to-severe plaque psoriasis.

UNION therapeutics expects to commence the Phase 2b trial in second half of 2021.

About orismilast
Orismilast is an investigational drug candidate that is a selective inhibitor of phosphodiesterase type 4, commonly referred to as PDE4. PDE4-inhibition is a validated pharmacological target for inflammatory indications. Orismilast is a next-generation PDE4-inhibitor with an improved therapeutic window, and attractive physicochemical properties allowing it to be formulated for multiple routes of administration, including oral (UNI50001) and topical (UNI50002). 

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 and has five 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.

Sources
1: Li et al. (2018)
2: Menter MA, Armstrong AW, Gordon KB, Wu JJ. Common and Not-So-Common Comorbidities of Psoriasis. Semin Cutan Med Surg. 2018 Feb;37(2S):S48-S51. doi: 10.12788/j.sder.2018.011.

Contacts

UNION therapeutics
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: morten.boesen@uniontherapeutics.com

Szpirt & Company
Marie-Louise Jersin                        
Senior PR Manager
Tel: +45 3049 4967
Email: mlj@szpirt.com
 

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