Allgenesis Biotherapeutics Inc., a clinical-stage pharmaceutical company dedicated to developing advanced ophthalmic drugs, recently released exciting topline data from its Phase 1b clinical trial for AG-80808. AG-80808 is a pioneering formyl peptide receptor (FPR) agonist formulated as an aqueous eye drop, created to address the needs of patients suffering from Dry Eye Disease (DED).
The trial, conducted in multiple centers and following a double-masking protocol, studied the safety, tolerability and dose-response of AG-80808 Formulation A 0.001%, 0.03%, or 0.1% and Formulation B 0.03% when applied twice daily, over the course of three months to 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:
Improvements in corneal staining, conjunctival staining, and tear production are often seen in patients who respond positively to treatment. Such signs indicate progress towards better eye health.
Patients have reported considerable improvements in their eye discomforts such as dryness, burning, stinging, itching, foreign body sensation, photophobia, and pain, according to a 7-item visual analog scale. These improvements have been achieved through regular use of eye lubricants.
Formulation A 0.001% and Formulation B 0.03% emerged as the most successful in terms of efficacy, safety, and tolerability. This powerful combination proved to be a winning recipe for a safe and effective experience.
The results of Allgenesis’ Phase 1b trial have been highly encouraging, showing that dry eye syndrome sufferers experienced improvement in multiple signs and symptoms as quickly as two weeks. With AG-80308, those suffering from this condition are presented with an effective and safe long-term treatment that is free from the adverse effects seen with other therapies. According to Dr. Madhu Cherukury, CEO of Allgenesis, “This new development truly offers hope to those affected by this condition.”
The Phase 1b trial results for AG-80308 in formulation B, a promising drug for treating chronic dry eye conditions, are incredibly positive! We are excited to move forward to the Phase 2 trial, which will assess the efficacy of two different doses of AG-80308 in comparison to a placebo.
With its unique and potent mechanism of action, AG-80308 is sure to revolutionize the treatment of this difficult-to-manage condition. Dr. Sunil Patel, Chief Medical Officer Allgenesis, is optimistic regarding the Phase 2 results.
About Allgenesis Biotherapeutics Inc.
Allgenesis is a biopharmaceutical company on a mission to strive for a better future of eye care. Headquartered in Taipei, Taiwan, Allgenesis is dedicated to developing groundbreaking drugs to treat a range of retinal diseases, ranging from diabetic macular edema (DME) to neovascular age-related macular degeneration (nAMD) to retinal vein occlusion (RVO).
The company’s two major projects, AG-73305 and AG-80308, are being rigorously researched and tested, with great expectations that they may soon become potential blockbusters for treating these conditions. Allgenesis is committed to improving eye health and bringing hope to patients all over the world.
About AG-80308
AG-80308 is a groundbreaking eye drop solution that was recently licensed from Allergan (now AbbVie) to treat Dry Eye Disease (DED) related inflammation. It is the world’s first Formyl Peptide Receptor (FPR) agonist, specifically designed to be applied directly as an aqueous solution. It is sure to be a game-changer as it offers hope to those suffering from debilitating DED symptoms.