Zealand University Hospital

Late-breaking presentation of data from the OSIRIS IIT PoC study of oral orismilast in hidradenitis suppurativa (HS) at the European Academy of Dermatology and Venerology Congress 2023 Additional e-posters on the efficacy and safety of orismilast in moderate-to-severe psoriasis from the IASOS Phase 2b study and biomarker analyses from the skin of patients in the IASOS study, will be presented Positive topline data from the IASOS study was reported early January 2023 and for the OSIRIS study in June 2023 Orismilast is a next generation high-potency PDE4B/D selective inhibitor with broad anti-inflammatory properties in development for oral treatment of atopic dermatitis (AD), HS and psoriasis HELLERUP, Denmark, Oct. 6, 2023 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced acceptance of a late-breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress 2023 on October 11-14, 2023, in Berlin, Germany. New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec. Additionally, two e-posters from the IASOS Phase 2b study will be presented at the EADV Congress 2023, describing the clinical efficacy and safety of orismilast and its impact on biomarkers measured in the skin of moderate-to-severe psoriasis patients. Oral presentation details Presentation: A Phase 2a, open-label, single-center, single-arm, dose finding 16 weeks clinical trial of orismilast for the treatment of hidradenitis suppurativa Presenter: Prof., Dr. Gregor Jemec, Founding Chairman of the Department of Dermatology, Zealand University Hospital, Denmark Session code: D2T01.3I Date and time: Thursday, October 12, 2023, at 16:30-16:45 CEST E-poster details Poster title: Molecular effects in the skin of psoriasis after oral treatment with orismilast Authors: James G. Krueger, Richard B. Warren, Emma Guttman-Yassky Poster ID: P2420 Poster title: Significant improvements in signs and symptoms with orismilast in moderate-to-severe psoriasis: Efficacy, safety and sub-analyses from the Phase 2b IASOS trial Authors: Richard B. Warren, Lars E. French, Andrew Blauvelt Poster ID: P2387 Professor Gregor B. Jemec, PhD, MD, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark and sponsoring investigator of the study says: "A strong unmet need remains for a safe and effective oral treatment for hidradenitis suppurativa. The promising topline results from the OSIRIS study illustrates that potent PDE4 inhibition by orismilast offers the potential for additional efficacy in combination with a well-known safety profile from the PDE4 class." Kim Kjøller, Chief Executive Officer of UNION therapeutics adds: "We are pleased that results from the OSIRIS IIT PoC study have been selected as a late-breaking presentation at the EADV Congress 2023. Additionally, we are super excited about presenting two posters with new data on orismilast at the 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 atopic dermatitis, hidradenitis suppurativa and psoriasis. We look forward to the results being shared and discussed with the leading experts in the field." About orismilast Orismilast is a next generation, high potency PDE4B/D selective inhibitor, selectively targeting the PDE4B/D subtypes linked to inflammation, leading to potent inhibition of Th1, Th2 and Th17 pathways. It operates early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1) UNION is developing orismilast as an efficacious but safe oral treatment across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis, hidradenitis suppurativa and psoriasis. The FDA has cleared UNION's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan. Sources Silverberg J.I. et al., Pharmacology of orismilast, a potent and selective PDE4 inhibitor, JEADV 2022: Warren R.B. et al., Efficacy and safety in moderate-severe psoriasis and development of modified release tablets, JEADV 2022: 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, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. 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 SOURCE UNION therapeutics

Study demonstrates clinically relevant improvements in patients with hidradenitis suppurativa (HS) receiving 16 weeks of treatment with oral orismilast Study supports the dose-finding results from the recent IASOS Phase 2b study of oral orismilast in psoriasis Orismilast has been granted a Fast Track designation by the FDA for HS, and UNION plans to seek regulatory advice on the design of the pivotal study program Orismilast is a high potency, next-generation PDE4 inhibitor with broad anti-inflammatory properties also in development for oral treatment of atopic dermatitis (AD) and psoriasis HELLERUP, Denmark, June 21, 2023 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately-held, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announces positive topline results from the OSIRIS investigator-initiated proof-of-concept study with oral orismilast in adult patients with HS. HS is a painful, scarring, inflammatory skin disease with few or limited treatment options. The study demonstrated clinically relevant improvements in HS for patients who completed the planned 16 weeks of treatment with oral orismilast. Importantly, the improvements included reduction of pain (Global Pain Assessment) and improvement in patient-reported quality of life (DLQI). Most responders had moderate or severe HS at baseline, including several prior failures to biologics treatment. The conclusion on the doses explored is consistent with the findings from the subsequent IASOS Phase 2b dose-finding study in psoriasis recently reported. The target product profile of oral orismilast was confirmed including the well-established favorable safety profile of PDE4 inhibition. The results will be presented by the sponsoring investigator at an upcoming scientific conference, and UNION expects to further progress the development of oral orismilast in HS. Professor Gregor B. Jemec, PhD, MD, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark and sponsoring investigator of the study said: "Hidradenitis suppurativa is an inflammatory systemic skin disease where a strong unmet need remains for safe and effective oral treatments. Patients suffer from pain discharge and scarring of intimate skin areas. The positive topline data from the OSIRIS study are very encouraging." Kim Kjøller, Chief Executive Officer of UNION therapeutics said: "We are delighted to see positive topline results from the OSIRIS study. The results are very encouraging, including not least seeing patients in this difficult to treat patient population achieving HiSCR90 and HiSCR100 response. Equally important, patients experienced significant reduction in pain, which is a great burden for patients with HS, and most responders had moderate or severe HS at baseline, including several prior failures to biologics treatment. The study supports the target product profile of orismilast as a high-potency PDE4 inhibitor consistent with the recent IASOS Phase 2b study in psoriasis. We are looking forward to advancing orismilast in HS and will engage with the regulatory authorities around the best path to approval." About the OSIRIS Phase 2 study OSIRIS is an open-label, single-center, prospective, single arm, investigator-initiated proof-of-concept study investigating the efficacy, safety, and tolerability of oral orismilast taken twice daily for up to 16 weeks in adult patients with mild, moderate, and severe HS. About HS and treatment of HS HS is a chronic, inflammatory skin disease which results in painful inflammation of the hair follicles, most notably in the armpit and genital 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. HS severely and adversely affects patients' quality of life and is associated with an increased overall mortality rate due to cardiovascular disease and suicides.1) Currently, only one drug (a biologic) is approved for treatment of moderate to severe HS in the US. For mild HS there are no treatments approved. The general standard of care for HS patients, although off-label, includes topical, oral or intravenous antibiotic treatment which often provides only temporary symptomatic relief. Antibiotics do not target the underlying inflammation and they are associated with resistance development.2) About orismilast Orismilast is a high-potency, next-generation PDE4 inhibitor targeting the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.3) UNION is developing orismilast as an efficacious but safe oral treatment across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis, hidradenitis suppurativa and psoriasis. The FDA has cleared UNION's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan. Sources 1) Ballard et al., Hidradenitis Suppurativa, StatPearls 2022: and Thorlacius et al., Increased Suicide Risk in Patients with Hidradenitis Suppurativa, The Journal of Investigatory Dermatology, 2018: 2) Saunte et al., Hidradenitis Suppurativa: Advances in Diagnosis and Treatment, JAMA, 2017: 3) Silverberg J.I. et al., Pharmacology of orismilast, a potent and selective PDE4 inhibitor, JEADV 2022: & Warren R.B. et al., Efficacy and safety in moderate-severe psoriasis and development of modified release tablets, JEADV 2022: 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, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. 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 The following files are available for download: SOURCE UNION therapeutics

FDA's Fast Track designation for oral orismilast underscores the urgent need for new treatment options to fulfil the unmet medical need for people affected by moderate to severe hidradenitis suppurativa (HS) HS is a chronic, progressive, inflammatory, and scarring skin disease leading to a diminished quality of life, for which very limited treatment options exist Orismilast is a high-potency PDE4 inhibitor with broad anti-inflammatory properties also in development for oral treatment of psoriasis and atopic dermatitis (AD), for which a Fast Track designation has also been granted in AD HELLERUP, Denmark, Jan. 10, 2023 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral orismilast for the treatment of moderate to severe HS. The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address a significant unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review. In the coming interactions with FDA, UNION plans to discuss the most appropriate endpoints, target disease severity, and next steps in the clinical development of oral orismilast for the treatment of HS. In September, the Danish Medicines Agency and Ethics Committee granted a Treatment Extension to the ongoing investigator-led study of oral orismilast (OSIRIS, Phase 2a)1) for the treatment of patients with mild to severe HS. With the Treatment Extension, patients who have completed the initial treatment period in the OSIRIS study may continue treatment with orismilast MR tablets for a period of 52 weeks. Professor Gregor B. Jemec, PhD, MD, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark said: "Hidradenitis suppurativa is an inflammatory systemic skin disease that seriously affects the life of patients. Despite the recent advances in the treatment of hidradenitis suppurativa, there is still a high unmet need in terms of safe and efficacious oral treatments. It is encouraging to see that FDA recognizes the potential of oral orismilast in hidradenitis suppurativa and grants it fast track designation." Kim Kjøller, Chief Executive Officer of UNION therapeutics said: "We are very pleased to receive this Fast Track designation for oral orismilast in hidradenitis suppurativa (HS) and look forward to working closely with the FDA in the design of the clinical development program for oral orismilast. Our ambition is to provide an effective oral treatment for HS and in collaboration with dermatologists and patients develop relevant trial designs, addressing the true needs of patients living with HS." About orismilast UNION is developing orismilast, a high-potency PDE4 inhibitor targeting the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases. 2) Orismilast holds the potential to become a safe and efficacious oral treatment for many immunological diseases, and UNION is currently developing oral orismilast for the treatment of AD, psoriasis, and HS. The FDA has cleared UNION's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan. About HS and treatment of HS HS is a chronic, progressive, inflammatory skin disease that usually develops after puberty as a result of inflamed hair follicles, most notably in the armpit and genital regions. The clinical hallmarks of the disease include very painful inflammatory nodules, boils or abscesses that typically open and release odorous inflammatory fluids. As HS progresses, the scars form tunnels or sinus tracts that connect. HS patients suffer primarily from pain and significant discomfort as a result of the constant formation of pus, and often require the use of bandages, resulting in social isolation. Many patients are stigmatized by these symptoms, leading to a very diminished quality of life. HS is associated with various more general diseases, such as arthritis and metabolic syndrome. Currently, there is only one drug approved for the treatment of moderate to severe HS, which is a biologic administered through injections. For mild HS there are no treatments approved. The general standard of care for HS patients, although off-label, includes topical antiseptics and oral antibiotic treatment which often provide only temporary symptomatic relief. Antibiotics do not target the underlying inflammation and they are associated with resistance development. 3) Sources 1) Taudorf E.H. and Jemec G.B. OSIRIS – Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa: Rationale and Design.11th Conference of the European Hidradenitis Suppurativa Foundation. 2022 Feb 9-11. PV-05-02 and Taudorf E.H. et al. Rapid reduction of inflammation in severe hidradenitis suppurativa following treatment with the PDE4-inhibitor Orismilast, oral presentation at 11th Conference of the European Hidradenitis Suppurativa Foundation. 2022 Feb 9-11 2) Silverberg J.I. et al., Pharmacology of orismilast, a potent and selective PDE4 inhibitor, JEADV 2022: & Warren R.B. et al., Efficacy and safety in moderate-severe psoriasis and development of modified release tablets, JEADV 2022: 3) Saunte D.M.L. and Jemec G.B., JAMA 2017: 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 The following files are available for download: SOURCE UNION therapeutics