- Aclaris Therapeutics Inc ACRS flunked a 12-week, Phase 2a study of zunsemetinib (ATI-450) for moderate to severe hidradenitis suppurativa.
- The study did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count (AN) of zunsemetinib 50mg BID versus placebo at week 12. The study did not meet the secondary efficacy endpoints.
- William Blair writes that while the negative results are disappointing and represent a setback, it does not change the thesis that zunsemetinib may demonstrate promising results in the ongoing Phase 2 studies in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) expected later in 2023.
- In addition to zunsemetinib, preliminary data from ATI-1777, the company’s second compound from the KINect drug discovery platform, suggest the compelling efficacy of ATI-1777 in atopic dermatitis (AD) without the adverse event baggage of the broader class of JAK inhibitors, and validate Aclaris’s development platform, the analyst writes.
- The analyst believes the company’s current enterprise value of about $700 million significantly undervalues the potential for zunsemetinib in several blockbuster indications and the value in the company’s pipeline, including ATI-1777 and ATI-2138.
- William Blair maintains Outperform rating.
- Price Action: ACRS shares are down 48.79% at $6.55 on the last check Monday.
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