Allgenesis announces Phase 1b data showing AG-80308 providing improvements in dry eye patients

According to Allgenesis, AG-80308 was found safe at all doses tested BID for 3 months. (Image courtesy of Adobe Stock)

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).

According to the company, the Phase 1btrial 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.

The company noted AG-80208 is a novel, first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop to treat the inflammation linked with DED. It was in-licensed from Allergan (now AbbVie) in 2020.

Allgenesis pointed out in the news release that AG-80308 was found 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.

Madhu Cherukury, PhD, CEO of Allgenesis, said the company was encouraged by its data showing that patients are seeing improvements in multiple signs and symptoms from the Phase 1b trial as early as 2 weeks.

“AG-80308 can offer dry eye patients an effective treatment that can be used long-term without the AEs associated with other therapies,” Cherukury said in the news release.

Sunil Patel, MD, chief medical officer of Allgenesis, pointed out in the news release that amid the positive results from the Phase 1b trial, and the company is looking forward to moving the program into Phase 2, where it 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,” Patel said in the news release.

Allgenesis has begun preparations to support initiation of the Phase 2 trial in the first quarter of 2024