Allgenesis Announces First Patient Enrollment in a FIH Phase 2a Trial of AG-73305 for the Treatment of Diabetic Macular Edema

Allgenesis Announces FDA Clearance of the IND for AG-73305 for the Treatment of Diabetic Macular Edema
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Taipei, Taiwan/June 13th, 2022 

Allgenesis today announces the first patient enrollment in the DME trial for AG-73305 (NCT05301751), following the customary clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The Phase 2a trial is a multicenter, open-labeled study to evaluate the safety, tolerability, and efficacy of intravitreal AG-73305 in patients with DME. The study’s goal is to assess whether AG-73305 has an acceptable safety profile and whether AG-73305 demonstrates some clinical beneficial effects on improvements to BCVA and central subfoveal thickness. 

“We are excited to have reached this major milestone for Allgenesis of first patient enrolled in our Phase 2a trial,” said Dr. Madhu Cherukury, CEO of Allgenesis. “We are looking forward to obtaining clinical data in patients. This is an important step for Allgenesis as our company grows to accelerate our development efforts with AG-73305”.  

“Despite the success of anti-VEGF monotherapies commercially, a significant proportion of patients either lose efficacy over time or are non-responders. We designed our molecule to offer additional benefits by blocking multiple VEGF and integrin targets to address retinal neovascularization and permeability, macular edema, fibrosis, and inflammation which are not fully controlled with current anti-VEGF monotherapies. We look forward to the clinical benefit that AG-73305 treatment can potentially provide to DME patients”, said Dr. Sunil Patel, Chief Medical Officer.  

Allgenesis intends to accelerate the development of AG-73305 and collaborate with AffaMed Therapeutics for development in China and other Asian markets. The two companies entered into a licensing agreement for the development of AG-73305 in territories for Greater China, ex-Japan and Taiwan.  

Allgenesis expects to report interim data in 2H22. 

About AffaMed Therapeutics 

AffaMed Therapeutics is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs in ophthalmic, neurological and psychological disorders for patients in Greater China and around the world. The leadership team of AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality clinical development, regulatory affairs, CMC, business development and commercial operations at leading multi-national pharmaceutical companies in China and globally. AffaMed Therapeutics was founded and funded by the CBC Group in 2019. 

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. 

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.