Allgenesis Biotherapeutics has teased preliminary data from a Phase IIa trial investigating its AG-73305 drug in patients with diabetic macular oedema (DMO). The Taiwan-based company anticipates releasing the final topline results with data from the last two cohorts in Q4 2023.

The preliminary data showed that the 0.5mg dose of AG-73305 demonstrated a median improvement in Best Corrected Visual Accuity (BCVA) of eight ETDRS letters with a Central Subfield Thickness (CST) reduction of -57.9 microns. The 1mg dose showed median improvement in BCVA of +14 ETDRS letters and CST reductions of -145 microns.

The 0.5mg and 1mg doses recruited three patients each. The efficacy in all six patients lasted between 12 and 24 weeks after a single intravitreal injection.

As for safety, both doses were safe and tolerable after a single injection. There were no dose-limiting toxicities or serious adverse events (SAEs) related to the treatment.

Chief medical officer Dr Sunil Patel said that given the positive data, Allgenesis is forging ahead with its plans to initiate a Phase IIb study in DMO patients.

The open-label trial (NCT05301751) is evaluating 0.5mg, 1mg, 2mg and 4mg intravitreal doses of AG-73305 in patients with DMO. The primary endpoint is measuring incidences of adverse events (AEs) and SAEs, while secondary endpoints are evaluating mean change in BCVA and CST. In April, Allgenesis announced enrolment of the last patient into the trial.

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AG-73305 is a bi-specific Fc-fusion protein designed to block vascular endothelial growth factor (VEGF) and integrins. In September 2021, Allgenesis entered a licensing agreement with AffaMed Therapeutics to develop and commercialise AG-73305 in Greater China, South Korea and multiple Association of Southeast Asian Nations (ASEAN) markets.

DMO landscape

DMO is a leading cause of blindness in diabetic patients. It is a complication of diabetic retinopathy, which is defined as retail thickening that involves the macula, the centre of the retina.

According to GlobalData’s epidemiological analysis, the diagnosed prevalent cases of DMO are expected to increase from 1,724,733 cases in 2021 to 2,011,811 cases in 2031 in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). Epidemiologists attribute the increase in diagnosed cases to changes in population dynamics in each market.

GlobalData’s expert analysis indicated that the DMO market is anticipated to reach values of $11.1 billion in 2031 across 7MM. The estimated growth is a result of Roche’s Vabysmo (faricimab) approval in 2022 by the US Food and Drug Administration (FDA), coupled with other anticipated approval of pipeline therapies.