Allgenesis announces preliminary safety and efficacy data from AG-73305 Phase 2a trial for treatment of DME

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Allgenesis Biotherapeutics Inc. this week announced preliminary data from the initial cohorts of the on-going AG-77305 FIH Phase 2a clinical trial for the treatment of Diabetic Macular Edema (DME) in the United States.

In addition, Allgenesis announced in a news release it dosed the final patient in April 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 this year.

The company noted the 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." Madhu Cherukury, PhD, DABT, CEO of Allgenesis, said in a news release. "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."

Sunil Patel MD, PhD, chief medical officer, said company officials were 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,” Patel said.

Moreover, Cherukury was looking to the future in the wake of the positive results.

"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." Cherukury said in the release.

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.