The primary endpoint, HiSCR50, was met at week 16 by 6 out of 10 patients in the MC2-32 group compared to 1 of 5 in the placebo group.

MC2-32 (previously RGRN-305), a first-in-class, oral therapy HSP90 inhibitor, performed well in Hidradenitis Suppurativa (HS), according to Phase 2a results presented during a late-breaking session at the European Academy of Dermatology and Venereology (EADV) Annual Meeting in Berlin.

The single center, Phase 2a, clinical trial conducted at Aarhus University Hospital, Denmark evaluated the efficacy and safety of MC2 Therapeutics' MC2-32 in patients with moderate to severe (Hurley stage 2 or 3) HS. Fifteen patients were recruited for the study and randomized 2:1, to 16 weeks oral treatment with 250 mg MC2-32 once daily or placebo. The study was a Phase 2a proof-of-concept study and not designed to obtain statistical significance. All included patients completed the study.

The primary endpoint, Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16 was achieved by 6 out of 10 patients in the MC2-32 group versus 1 out of 5 patients in the placebo group. The harder-to-reach HiSCR75 and HiSCR90 were achieved by 5 and 3 patients out of 10 in the MC2-32 treated group, respectively whereas none in the placebo group achieved HiSCR75 and HiSCR90 responses. All other secondary endpoints, including IHS4, HS-PGA, DLQI, and pain-NRS pointed towards better response rates in the MC2-32 treated group compared to placebo, the study showed.

MC2-32 was well-tolerated with no serious adverse events and treatment-emergent adverse events were similarly frequent between the MC2-32 and the placebo groups. Moreover, there were no clinically significant changes in blood biochemistry seen throughout the study.

"Inhibiting HSP-90 leads to the inhibition of multiple inflammatory pathways related to HS not just IL-17, while the exceptional pharmacological properties provide a remarkably favorable safety profile. We believe that MC2-32's broad spectrum approach combined with oral delivery will propel the product to best-in-class status in the HS field," says Professor Lars Iversen, CMO of MC2 Therapeutics, in a news release. "Using HiSCR75 as our primary endpoint, we are now laser-focused on preparing for our randomized, double-blinded, placebo-controlled Phase 2b trial."

Jesper J. Lange, CEO of MC2 Therapeutics, adds, "With these compelling data, unique mode of action and oral delivery, MC2-32 has the potential to be a game-changer in the treatment of HS. Joining our strong portfolio of immunology and inflammation treatments in development and on the market, MC2 Therapeutics is on its way to becoming an emerging force in the field."