Investors Cheer Acelyrin's Stock, Its Second Lead Candidate Shows Clinical Benefit In Thyroid Eye Disease Patients

Wednesday, Acelyrin Inc SLRN released proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED). 

Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action for TED.

In the Phase 1/2 trial, lonigutamab demonstrated rapid improvements in proptosis and clinical activity score (CAS) at the first measurement – within three weeks after the first subcutaneous dose.

Also Read: Acelyrin’s Lead Drug Candidate Hits Primary Goal In Late-Stage Psoriatic Arthritis Study.

Reduction in Proptosis (eye bulge) was 50% in Lonigutamab 40mg Q3W and 67% in the 50mg arm compared to 0% in placebo.

CAS response was 100% in the 40mg arm compared to 83% in the 50mg arm and 0% in the placebo arm.

Improvement in diplopia (double vision) was 25% vs. 40% vs. 0%.

Overall, lonigutamab has been well-tolerated across our clinical experience to date. 

There have been no reports of hyperglycemia or hearing impairment and no serious adverse events. 

With proof of concept achieved in Cohort 1, and Cohort 2 further validating these results, a Phase 2b/3 trial is planned to be initiated in the second half of 2024, designed to be the first of two registrational trials in TED.

Given the proximity of the recent data announcements for izokibep and lonigutamab and today’s conference call, Acelyrin will forego hosting the fiscal year 2023 earnings call. 

The company will instead announce its financial results in a press release and file the related 10-K report no later than April 1, 2024.

Price Action: SLRN shares are up 6.53% at $8.48 on the last check Wednesday.