We are investigating whether Acelyrin, Inc. (Nasdaq: SLRN) (“Acelyrin”) violated federal securities laws in connection with its prior public statements concerning the potential of its lead drug candidate, izokibep. Please see further details concerning the investigation below.
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Why is there an investigation?
Acelyrin is a late-stage clinical biopharma company focused on developing and commercializing transformative medicines. Its lead drug candidate is izokibep, which is currently in development for treatment of hidradenitis suppurativa (HS), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA) and uveitis.
Active ongoing trials with izokibep include Part B of a Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe HS.
Efficacy of treatments in HS is typically measured by improvements in Hidradenitis Suppurativa Clinical Response (HiSCR). HiSCR is a clinically validated scoring system that is used to assess disease activity. HiSCR50 represents a 50% improvement in abscesses and inflammatory nodules without worsening in either of these individually or worsening in tunnelling. High order responses, such as 75% improvement (HiSCR75), 90% improvement (HiSCR90) and 100% improvement (HiSCR100, which means there are no abscesses or inflammatory nodules and no new fistulae/tunnels), represent even greater clinical responses on the reduction of inflammatory nodules and abscesses as well as fistulae/tunnels.
On Acelyrin’s Q2 2023 earnings call on August 16, 2023, Acelyrin’s CEO, Shao-Lee Lin advised analysts that the “totality of evidence across these two independent data sets of HS and PsA continues to support the hypothesis that the high potency and small molecular size of izokibep can lead to clinically meaningful differentiated benefits for patients: in HS, HiSCR100 responses in 33% of patients at week 12 and improvements in draining tunnels within the first month of therapy.”
On September 11, 2023, after the markets closed, Acelyrin announced disappointing top-line results from Part B of the Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe HS. Specifically, izokibep failed to show statistically significant reduction in abscesses and inflammatory nodules (i.e., HiSCR75 at week 16) in patients as compared to placebo.
On this news, Acelyrin’s stock price fell 54.12% in trading to a close of $12.80 on September 12, 2023, from its prior close of $27.90 on September 11, 2023.
On September 13, 20203 Acelyrin’s stock price fell another $2.09 to close at $10.71.