Hellerup, Denmark, 19 August 2022 – UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, today announced it will present new preclinical data on orismilast’s inhibition of various inflammatory cytokines, and additionally present an e-poster on the safety and efficacy of orismilast immediate release formulation at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-10 September 2022 in Milan, Italy and online.

The preclinical study supports orismilast’s potential in AD, psoriasis, and HS, and further differentiates orismilast from other PDE4 inhibitors 1). The Phase 2a data on orismilast IR supports the potential of orismilast for the treatment of psoriasis.

Kim Kjøller, Chief Executive Officer of UNION therapeutics said:

“We are excited to debut preclinical data on orismilast, a potent next-generation PDE4 inhibitor, at the EADV Congress. The data presented at EADV demonstrate the attractive profile of orismilast and its potential to be a first or best-in-class candidate for the treatment of psoriasis, atopic dermatitis, and hidradenitis suppurativa.”

 

Oral presentation details

Oral presentation: Pharmacology of orismilast, a next generation PDE4 inhibitor

Presenter: Prof. Dr. Jonathan Silverberg, George Washington University School of Medicine and Health Sciences

Authors: J.I. Silverberg, L.E. French, R.B. Warren, B. Strober, K. Kjøller, M. Sommer, P. Andres, J. Felding, A. Weiss, D. Tutkunkardas, E. Guttman

Session title: FC01: Free communications: miscellaneous – Exact session identifier: FC01.02

Session date and time: Thursday 8. September 2022 at 8:40-8:50am.

 

E-poster details

Poster title: Oral Orismilast: Efficacy and Safety in Moderate-Severe Psoriasis and Development of Modified Release Tablets

Authors: R.B. Warren, B. Strober, J.I. Silverberg, E. Guttman, K. Kjøller, M. Sommer, P. Andres, J. Felding, D.Tutkunkardas, L.E. French

 

About orismilast

UNION is developing orismilast, which is a next-generation phosphodiesterase type-4 (“PDE4”) inhibitor with high potency for the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade to induce a broad range of anti-inflammatory effects. Orismilast has the potential to inhibit many inflammatory pathways involved in dermatological and immunological diseases and holds the potential to become a safe and efficacious treatment option in these diseases.

 

UNION has two product candidates based on orismilast in its clinical stage pipeline: Orismilast MR tablet currently investigated for the treatment of psoriasis, AD and HS; and topical orismilast with clinical proof of concept established in AD. UNION is progressing orismilast as a modified release tablet to minimize the occurrence of gastrointestinal side effects typically associated with PDE4 inhibition.

 

In November 2020, the FDA cleared UNION’s Investigational New Drug (IND) application for orismilast MR tablet, and in November 2021, the FDA granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD.

In September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologics for orismilast in Mainland China, Hong Kong, Macau and Taiwan2).

Sources

1)      In vitro study to assess the effect of orismilast on cytokine production in human PBMCs. Study number: DSK0001

2)      https://uniontherapeutics.com/union-therapeutics-and-innovent-biologics-enter-into-strategic-collaboration-and-license-agreement-for-orismilast-a-next-generation-pde4-inhibitor-for-inflammatory-dermatology-conditions-1/

 

Contacts

Morten Boesen, Chief Financial Officer, UNION therapeutics A/S

+45 2381 5487

[email protected]

 

Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S

+45 5385 3044

[email protected]

 

About UNION therapeutics

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