· AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of 0.5 mg and 1 mg in DME patients.
· AG-73305 showed median improvements in Best Corrected Visual Accuity (BCVA) of 8.5 ETDRS letters with median Central Subfield Thickness (CST) improvements of -110 microns from baseline across the 2 doses.
· The efficacious effects in all 6 patients lasted between 12 and 24 weeks after a single injection of AG-73305.
AffaMed Therapeutics (“AffaMed”) announced today that its partner Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, reported exciting preliminary data from the two initial cohorts of the on-going AG-77305 FIH Phase 2a clinical trial for the treatment of Diabetic Macular Edema (DME) in the US. In addition, Allgenesis completed dosing of the last patient in April 2023, and anticipates the release of the final topline data, including data from the latter two cohorts (the 2 and 4 mg cohorts), in the fourth quarter of 2023.
Preliminary data from the 0.5 mg (n=3) and 1 mg (n=3) cohorts demonstrated that AG-73305 was safe and tolerable after a single intravitreal injection. There were no dose-limiting toxicities and no SAEs related to AG-73305 in patients. The 0.5 mg cohort showed median improvement in BCVA of +8 ETDRS letters with CST reduction of -57.9 microns. The 1 mg AG-73305 cohort showed median improvement in BCVA of +14 ETDRS letters and CST reductions of -145 microns. All 6 patients responded to the treatment with efficacy lasting between 12 and 24weeks after a single injection.
“We are thrilled to share this exciting preliminary data and anticipate continued improvements as we treat patients with higher doses of AG-73305.” said Madhu Cherukury, Ph.D., DABT., CEO of Allgenesis. “The current data for AG-73305 supports our hypothesis that blocking multiple pathways in the disease state can provide additional benefits to DME patients in the form of BCVA gains and durability.”
Dr. Dayao Zhao, CEO of AffaMed commented “we are very encouraged by the safety and efficacy outcomes after just one intravitreal injection with the low doses. AG-73305, through its novel mechanism of action, has the potential to be a disease modifying therapy for retinal disease. We look forward to its continued development for the future benefit of DME patients globally and in China.”
In September 2021, AffaMed announced it had entered into a licensing agreement with Allgenesis for the development and commercialization of AG-73305 in Greater China, South Korea, and multiple ASEAN markets.
AG-73305 is a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of DME, nAMD, RVO, and other retinal diseases. AG-73305 contains a VEGF-trap and a disintegrin that blocks various key integrin receptors. AG-73305 has the potential to treat both anti-VEGF responders and non-responders.
About AffaMed Therapeutics
AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.