Union Therapeutics says positive phase 2 results show psoriasis hopeful can have wider skin benefits

Union Therapeutics has highlighted "positive" new phase 2 results for its anti-inflammatory drug in a painful skin condition as the Danish biotech prepares for a pivotal study in the indication.

The company said in a Wednesday morning press release that the OSIRIS investigator-led study showed “clinically relevant improvements” in patients with hidradenitis suppurativa who received the PDE4 inhibitor for 16 weeks. The biotech specifically pointed to reductions in pain and improvements in quality of life, although the release was light on the details.

The privately-held company added that the findings from the doses explored were consistent with the data from the IASOS phase 2b dose-finding study in psoriasis, which read out in January. Most of the patients began the trial with moderate or severe hidradenitis suppurativa that had failed to respond to existing biologics treatments.

"We are delighted to see positive topline results from the OSIRIS study,” said Union CEO Kim Kjøller, M.D., in the release. “We are looking forward to advancing orismilast in HS and will engage with the regulatory authorities around the best path to approval.”

As well as hidradenitis suppurativa—a condition that can cause lumps under the skin and for which the drug has secured an FDA fast-track tag—Union has been testing orismilast in atopic dermatitis and psoriasis. The later indication has been a hot research area this year, with Takeda and Johnson & Johnson-partnered Protagonist Therapeutics both posting data in recent months. And only yesterday, Eli Lilly handed over $2.4 billion to acquire Dice Therepeutics and its IL-17 inhibitors being developed for psoriasis.

Innovent clearly sees potential in orismilast, having paid out $20 million upfront in 2020 for the China rights to the drug. At the time, Union was touting orismilast as a potential rival to Amgen’s psoriasis blockbuster Otezla.