The trial is designed to evaluate the efficacy, safety and tolerability of AG-73305 in diabetic macular oedema patients. Credit: Jo Panuwat D / Shutterstock.

Allgenesis Biotherapeutics has reported initial findings from the Phase IIa clinical trial of AG-73305 to treat diabetic macular oedema (DME). 

The trial is designed to evaluate the efficacy, safety and tolerability of AG-73305 in 22 DME patients.

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According to the findings, a single intravitreal dose of AG-73305 was demonstrated to be safe and tolerable in the trial. 

No dose-limiting toxicities and serious adverse events linked to treatment with AG-73305 were reported. 

Four weeks after administering the injection, efficacy evaluations in the four trial cohorts revealed a mean best corrected visual acuity (BCVA) improvement of +6.4 ETDRS letters. 

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It also provided a -100 micron decline in mean central subfield thickness (CST).  

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The treatment effects were maintained for 12-24 weeks and nearly 66% chance of trial subjects not needing rescue by 24 weeks. 

Allgenesis CEO Madhu Cherukury said: “The data from our Phase IIa study supports the hypothesis that blocking multiple pathways in the disease state can provide additional benefits to DME patients in the form of BCVA gains with the potential to push for the extended durability versus the current standard of care.”

A humanised, bi-specific Fc-fusion protein, AG-73305 can hinder VEGF and integrin pathways at the same time.

The company signed a licensing deal with AffaMed Therapeutics in September 2021 to develop and market the drug in Greater China, South Korea, as well as other ASEAN countries.