A recent Phase 2 study conducted by Union Therapeutics has yielded positive results in patients suffering from hidradenitis suppurativa (HS) who were treated with the biotech’s oral drug orismilast twice daily for up to 16 weeks. Patients enrolled in the study had failed to respond to prior biologics treatment and mostly suffered from moderate or severe HS.
The OSIRIS investigator-initiated proof-of-concept study revealed that patients who completed the 16-week treatment showed improvement in their quality of life and reduced pain. OSIRIS is a single-center, open-arm prospective study meant to test the efficacy, safety, and tolerability of oral orismilast.
The firm has decided to share these positive results at an upcoming scientific conference and announced that it will further continue developing the drug for treating HS.
The IASOS Phase 2b dose-finding study in psoriasis conducted afterward echoes the results of this study and confirms the favorable safety and target product profile of the treatment. Additionally, the oral treatment has been granted Fast Track designation by the FDA for HS, and the firm will seek the advice of the agency regarding the design of its pivotal study program.
Researching drugs for the treatment of HS has been a hot topic this year. In fact, apart from Union, Johnson & Johnson-partnered Protagonist Therapeutics and Takeda have both posted data about the topic in recent months. Eli Lilly has also demonstrated interest in the area by paying over $2 billion just this week to acquire Dice Therapeutics and its IL-17, which is being developed as an inhibitor for psoriasis.
Regarding the OSIRIS study, Chief Executive Officer of Union Therapeutics, Kim Kjøller said, “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.”
HS is a chronic skin disease in which hair follicles, particularly in the armpits and genital area, are painfully inflamed. Patients suffering from the disease typically develop open boils and abscesses that release odorous inflammatory fluids. The disease causes great discomfort and social stigma as it results in the constant formation of pus, which is dealt with using diapers or bandages.
Union Therapeutics’ oral orismilast addresses the disease by acting as a high-potency PDE4 inhibitor, specifically targeting subtypes of PDE4 linked to inflammation. In developing the drug, the company also entered a strategic partnership with Innovent in 2021, according to which Innovent will be responsible for the drug in Mainland China, Hong Kong, Macau, and Taiwan.