Allgenesis Announces First Patient Dosed in the U.S. for the Phase 1b trial Evaluating AG-80308 for the Treatment of Dry Eye Disease

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Taipei, Taiwan/June 20th, 2022

Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, announces the first patient dosed for AG-80308, a first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop for the treatment of Dry Eye Disease (DED). AG-80308 was in-licensed from Allergan in 2020.

“We are excited to have reached this major milestone by dosing the first patient in our Phase 1b study for Dry Eye patients.” said Dr. Madhu Cherukury, the CEO of Allgenesis. “AG-80308’s unique MoA acts to provide anti-inflammatory benefits to Dry Eye patients and increases mucin levels which we hope will stabilize their tear film. We believe this has the potential to disrupt the dry eye vicious cycle and addresses unmet medical needs for DED”, added Dr. Cherukury.

The Phase 1b trial is a multi-center, double-masked study with plans to recruit up to 80 patients with DED. “The study’s goals are to assess safety, tolerability, and efficacy of lower doses compared to the prior Phase 1a study”, said Dr. Sunil Patel, Chief Medical Officer of Allgenesis. “There’s a need for a novel anti-inflammatory therapeutic for DED, such as AG-80308, that are non-immunosuppressive and non-steroidal. We also extended the treatment period to three months to assess the clinical benefits of long-term dosing of AG-80308 treatment.”

Allgenesis expects to report topline data for the Phase 1b trial in 1Q23.

About Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan. The company is focused on the 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-80308

AG-80308 is a novel, first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop for the treatment of inflammation associated with Dry Eye Disease (DED).