Oral HSP90 Inhibitor Gets Positive Feedback From FDA

A first-in-class oral drug candidate for the treatment of hidradenitis suppurativa (HS) received positive feedback from a pre-Investigational New Drug meeting with the US Food and Drug Administration (FDA), according to a press release.

MC2 Therapeutics, a commercial stage biotech company focused on developing novel treatment paradigms for immunology and inflammatory diseases, announced the news about MC2-32, an oral HSP90 inhibitor with a unique and highly specific pharmacological profile that elicits a full spectrum effect of HSP90 inhibition, without the class side effects. Alongside its pro-inflammatory action, MC2-32 has a specific targeted tissue distribution, supporting good clinical response profile, and tolerability, as demonstrated in a Phase 2a trial. “Based on initial positive feedback from the FDA and subject to the completion of already initiated pre-clinical studies, MC2 Therapeutics expects to file an IND for MC2-32 in HS in mid-2025,” the company said in the press release.

MC2-32’s unique mode of action positions it well to address a multitude of other neutrophilic dermatoses as well as other I&I diseases, the company said. Consequently, MC2 Therapeutics is planning to explore MC2-32 in a Phase 2 trial in pyoderma gangrenosum, a rare skin condition causing painful ulcers, for which there is a significant unmet patient need and no approved treatments. It is estimated that >50,000 people suffer from PG in the US and Europe alone.

The potential of MC2-32 will also be investigated in additional diseases in the skin and other organs.

“Encouraging feedback from the FDA marks an important milestone in the continued clinical development progress of our oral drug candidate MC2-32 and is a testament to the high quality of work by our team,” said Jesper J. Lange, CEO of MC2 Therapeutics. “Proceeding to the initiation of our Phase 2b trial for HS will be the first step to exploit the full potential of MC2-32 in several I&I indications where patients are currently left with no or limited treatment options. We look forward to working closely with the FDA, our investigators and stakeholders to advance the next phase of development.”