• PYC has initiated a global repeat dose study of its ADOA drug candidate PYC-001
• The study aims to evaluate the safety/tolerability and efficacy of repeat dosing in ADOA patients
• Data from the study is expected in H2 2026

PYC Therapeutics, a precision medicine company, has announced the initiation of a global repeat dose Phase 1b study of its investigational drug candidate PYC-001 in patients with Autosomal Dominant Optic Atrophy (ADOA), a blinding eye disease that affects 1 in 35,000 people and currently has no approved treatment options. The objective of the MYRTLE study is to evaluate the safety/tolerability and efficacy profile of repeat dosing of PYC-001 in the ADOA population, with the aim of establishing clinical proof of concept for the drug candidate prior to initiation of a registrational study. The study will evaluate three different doses of PYC-001 (10, 30 and 60 micrograms per eye) and two different dose intervals (8 and 12-week dosing intervals). The first ADOA patient has now received their initial dose of PYC-001 in their study eye via intravitreal administration. The study treatment period is projected to end in Q4 2026, and the results are expected to provide preliminary efficacy insights as well as determine the optimal dose and dosing regimen for PYC-001. The successful completion of this Phase 1b study and the subsequent Open-Label Extension study are intended to establish clinical proof-of-concept for PYC-001 in the ADOA population prior to progression into a global registrational trial, expected to commence in 2027, directed towards supporting a New Drug Application for PYC-001 in ADOA.

PYC Therapeutics is progressing its investigational drug candidate PYC-001 through clinical trials to address the underlying cause of Autosomal Dominant Optic Atrophy (ADOA), a blinding eye disease with no approved treatment options. The company has initiated a global repeat dose Phase 1b study to evaluate the safety, tolerability and efficacy of PYC-001 in ADOA patients, with data expected in H2 2026. This study and the subsequent Open-Label Extension study are intended to establish clinical proof-of-concept for PYC-001 prior to progression into a global registrational trial, expected to commence in 2027.