UNION therapeutics has announced positive topline results from its OSIRIS study of oral orismilast in adult patients with hidradenitis suppurativa (HS).
Orismilast, which is a high-potency, next-generation PDE4 inhibitor, targets the PDE4 subtypes linked to inflammation. The authors explain that “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.”
The OSIRIS open-label, single-center, prospective, single-arm, investigator-initiated proof-of-concept study investigated the efficacy, safety, and tolerability of oral orismilast. Adult patients with mild, moderate, and severe HS were given oral orismilast twice daily for up to 16 weeks.
Results of the study revealed a reduction of pain, as reported by the Global Pain Assessment, and an improvement in patient-reported quality of life (DLQI).
There is only one drug approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe HS, and none to treat mild cases. Union therapeutics has also announced that the FDA has granted orismilast Fast Track designation for HS.
“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.”
- https://uniontherapeutics.com/union-therapeutics-announces-positive-topline-results-from-the-osiris-investigator-initiated-proof-of-concept-study-of-oral-orismilast-in-patients-with-hidradenitis-suppurativa/
- https://www.dermatologytimes.com/view/oral-orismilast-shows-clinically-relevant-improvement-in-patients-with-moderate-to-severe-hidradenitis-suppurativa
