Taipei, Taiwan/April 18, 2023
Allgenesis Biotherapeutics Inc., a clinical-stage biopharmaceutical company focused on developing novel ophthalmic drugs, announced the last patient was enrolled in the first-in-human (FIH) DME trial for AG-73305. The Phase 2a trial is a multicenter, open-labeled study to evaluate the safety, tolerability, and efficacy of a single intravitreal injection of AG-73305 (0.5, 1, 2, and 4 mg) in patients with DME. In addition to assessing the safety profile of AG-73305, the company is also evaluating the potential effects on best-corrected visual acuity (BCVA) and central subfield thickness (CST). Allgenesis expects to release initial results from all cohorts of the study in 4Q23.
“We are very excited to have reached this significant milestone for Allgenesis in this FIH trial for AG-73305” said Dr. Madhu Cherukury, CEO of Allgenesis. “We are looking forward to the full topline data readout in 4Q23. AG-73305’s anti-vascular endothelial growth factor (VEGF) and anti-integrin bi-functional design allows it to address the multiple pathways involved in retinal diseases and the safety and efficacy results from the current trial will support the design for our planned Phase 2b studies in DME and neovascular age-related macular degeneration (nAMD) patients.”
“We are already seeing efficacy and durability in all patients dosed (non-naïve and naïve) after a single injection with AG-73305. The durability observed can be attributed to the anti-integrin mechanism, which we believe is modifying the DME disease state to benefit patients”, said Dr. Sunil Patel, Chief Medical Officer.
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, retinal vein occlusion (RVO), and other retinal diseases, and AG-80308 for Dry Eye Disease and other corneal surface diseases.
AG-73305 is a 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’s novel mechanism of action blocks various key integrin receptors that are important for cell-cell and cell-matrix interactions. This leads to disruption of downstream signaling and has the potential to modify the disease state to provide long-term efficacy.
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