AUD1001 / Eli Lilly, Massachusetts Eye and Ear, Audion Therap - LARVOL DELTA

Hidradenitis suppurativa and HS-like cutaneous adverse events associated with γ-secretase inhibitors (SID 2026) - "Seventeen studies met inclusion criteria, including 11 clinical trials, 4 case reports, and 2 cohort studies evaluating nirogacestat, crenigacestat, varegacestat, MK-0752, RO4929097, LY3056480, and semagacestat. While explicit diagnoses of HS were uncommon, GSIs were frequently associated with follicular and inflammatory cutaneous adverse events that overlap with HS phenotypes. These findings support a role for γ-secretase malfunction in HS pathogenesis and suggest that HS or HS-like disease may be under-recognized in patients receiving γ-secretase inhibitors."

Adverse events • Acne Vulgaris • Alzheimer's Disease • CNS Disorders • Dermatitis • Dermatology • Desmoid Tumors • Hidradenitis Suppurativa • Immunology • Infectious Disease • Sarcoma

A phase I/IIa safety and efficacy trial of intratympanic gamma-secretase inhibitor as a regenerative drug treatment for sensorineural hearing loss. (PubMed, Nat Commun) - "DPOAE amplitudes, SNRs and distribution of categories did not change from baseline to 6 and 12 weeks, nor did SRTs and HHIA/E scores. Intratympanic delivery of LY3056480 is safe and well-tolerated; the trial's primary endpoint was not met."

Journal • P1/2 data • Otorhinolaryngology

VESTA: A Trial of LY3056480 in Patients With SNLH (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Audion Therapeutics BV | N=135 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Otorhinolaryngology