Allgenesis Announces Encouraging Phase 1b Data Showing AG-80308 Providing Improvements in Multiple Signs and Symptoms in Dry Eye Patients

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ALHAMBRA, Calif. , June 19, 2023 /PRNewswire/ -- Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, today announced topline data from the company's Phase 1b clinical trial 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). The Phase 1b trial is a multi-center, double-masked study to evaluate the safety, tolerability, and dose-response of AG-80308 Formulation A 0.001%, 0.03%, or 0.1% and Formulation B 0.03% dosed twice daily for 3 months in 84 dry eye patients.

AG-80308 was considered safe at all doses tested BID for 3 months. AG-80308 provided improvements in both signs and symptoms:

• Signs: improvements in corneal staining, conjunctival staining, and tear production responders
• Symptoms: improvements in the 7-item visual analog scale, including dry eye discomfort, eye dryness, burning/stinging, itching, foreign body sensation, photophobia, and pain.
• AG-80308 Formulation A 0.001% and Formulation B 0.03% provided the best overall safety, tolerability, and efficacy profile.

"We are very encouraged with our data showing that patients are seeing improvements in multiple signs and symptoms from the Phase 1b trial as early as 2 weeks", said Dr. Madhu Cherukury, CEO of Allgenesis. "AG-80308 can offer dry eye patients an effective treatment that can be used long-term without the AEs associated with other therapies" added Dr. Cherukury.

 "With the positive results from the Phase 1b trial, we are looking forward to moving this program into Phase 2, where we will evaluate 2 doses of AG-80308 in formulation B against vehicle.  This will be an ideal drug for treating chronic dry eye patients due to its unique MOA and excellent potency" said Dr. Sunil Patel, Chief Medical Officer Allgenesis.

Allgenesis has begun preparations to support initiation of the Phase 2 trial in 1Q2024.

For additional inquiries regarding collaboration and partnering opportunities related to AG-80308, please contact Jack Chang ([email protected]) or Sandy Lai ([email protected]) for more information.

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-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). The project was in-licensed from Allergan (now AbbVie) in May 2020.

SOURCE Allgenesis Biotherapeutics Inc.