Allgenesis Biotherapeutics Announces Initial Safety and Efficacy Data from Phase 2a Clinical Trial of AG-73305 for Diabetic Macular Edema

ShanghaiMay 25, 2023PR Newswire -- AffaMed Therapeutics today announced that its partner Allgenesis Biotherapeutics (a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs) has reported exciting preliminary data from the first two cohorts of the ongoing first-in-human (FIH) trial of AG-77305 for DME in the United States. Allgenesis completed dosing of the last patient in this clinical trial in April 2023 and expects to release final pivotal data, including data from the last two cohorts (2 mg and 4 mg), in the fourth quarter of 2023.

Preliminary data from the 0.5 mg (n=3) and 1 mg (n=3) cohorts indicate that a single intravitreal injection of AG-73305 is safe and well-tolerated. No dose-limiting toxicity or AG-73305-related SAEs were observed in patients. The 0.5 mg cohort showed a median improvement of 8 ETDRS letters in BCVA and a median reduction of 57.9 in CST.μm。The 1 mg cohort showed a median improvement of 14 ETDRS letters in BCVA and a median reduction of 145 in CST.μm. All 6 patients showed improvement after treatment, with the effects lasting 12 to 24 weeks after a single injection.

"Allgenesis CEO Dr. Madhu Cherukury said, 'We are excited to share this promising preliminary data and look forward to observing more significant efficacy when treating patients with higher doses of AG-73305. The current data on AG-73305 support our hypothesis that blocking multiple signaling pathways in disease conditions can improve best-corrected visual acuity and produce longer-lasting effects, offering greater benefits to patients with DME.'"

AffaMed CEO Dr. Dayao Zhao commented, "We are very encouraged by the safety and efficacy results following a single intravitreal injection of low-dose AG-73305. With its innovative mechanism of action, AG-73305 has the potential to become a superior new therapy for retinal diseases. We look forward to the further clinical development of this drug, benefiting DME patients globally and in China."

In September 2021, AffaMed announced a licensing agreement with Allgenesis Biotherapeutics Inc. for the development and commercialization of AG-73305 in Greater China, South Korea, and multiple ASEAN markets.