Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema

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• 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.

TAIPEI, May 23, 2023 /PRNewswire/ -- Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, announces 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 4Q23.  

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 24 weeks 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."

"We are very encouraged by the safety and efficacy outcomes after just one intravitreal injection with the low doses", said Sunil Patel MD, PhD., Chief Medical Officer. "AG-73305, through its novel mechanism of action, has the potential to be a disease modifying therapy for retinal disease."

"Given the positive data that we are seeing from the open label study, we are forging ahead with our plans to initiate a Ph2b study in DME patients." said Dr. Cherukury.

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

For additional inquiries regarding collaboration and partnering opportunities related to AG-73305, please contact Jack Chang or Sandy Lai at [email protected] for more information.

About AG-73305

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 Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO, and AG-80308 for Dry Eye Disease.

SOURCE Allgenesis Biotherapeutics Inc.