Acelyrin Re-prioritizes Pipeline After Mixed Izokibep Results, Shifts Focus to Lonigutamab
核心洞察
Acelyrin's Phase 3 trial of izokibep for hidradenitis suppurativa (搜索) (HS) met its primary endpoint, with 33% of patients achieving HiSCR75 at Week 12 compared to 21% on placebo.
Despite positive results, Acelyrin will not advance izokibep for HS or psoriatic arthritis (搜索) (PsA) due to competitive concerns and insufficient efficacy.
The company is shifting its focus to lonigutamab for thyroid eye disease (搜索) (TED) and has reduced its workforce by 33% as part of the re-prioritization.
Acelyrin Inc. (NASDAQ:SLRN) is re-prioritizing its pipeline following the announcement of its second-quarter 2024 results and topline results from a Phase 3 study of izokibep for hidradenitis suppurativa (搜索) (HS). While the study met its primary endpoint, the company has decided to suspend further investment into izokibep for HS and psoriatic arthritis (搜索) (PsA), shifting its focus to the development of lonigutamab for thyroid eye disease (搜索) (TED).
The Phase 3 trial enrolled 258 patients to assess izokibep 160 mg weekly against a placebo. At Week 12, 33% of patients on izokibep achieved a HiSCR75, compared to 21% for the placebo group. The study also showed statistically significant improvements in HiSCR90 and HiSCR100, with deeper responses observed through Week 16.
Concerns over Competitiveness
Despite the positive outcomes, H.C. Wainwright expressed concerns regarding the competitiveness of izokibep in the HS treatment landscape, noting higher HiSCR75 responses in sonelokimab and bimekizumab during their respective Phase 2 and Phase 3 studies. This assessment contributed to Acelyrin's decision not to advance izokibep internally for HS treatment.
Strategic Shift
Acelyrin will also not pursue izokibep for Psoriatic Arthritis (搜索) (PsA), despite a positive Phase 2b/3 study, due to insufficient efficacy results. This strategic shift has led to a 33% workforce reduction. The company's financial report showed a net loss of $85.7 million for the quarter ended June 30, 2024.
The firm's decision to downgrade Acelyrin's stock reflects the removal of all izokibep sales from its model, given the company's strategic shift away from further internal development of the drug.
Analyst Ratings
Investment firm Piper Sandler maintained an Overweight rating on Acelyrin's stock. H.C. Wainwright adjusted its price target on Acelyrin's shares to $6.00 from $18.00 and downgraded to Neutral. Wells Fargo also increased its price target for Acelyrin to $13.00, maintaining an Equal Weight rating.