Allgenesis Biotherapeutics Inc., a clinical-grade specialty pharmaceutical company focused on developing new ophthalmic drugs, has announced topline data from phase 1b clinical trials for AG-80308, a class one formyl peptide receptor agonist (FPR) formulated as an aqueous eye drop solution for treatment of dry eye disease (DED).
AG-80308 was deemed safe at all doses tested for three months. AG-80308 provides improvement in signs and symptoms. There was an increase in corneal staining, conjunctival staining, and tear production responders. The company added there was improvement on a 7-item visual analogue scale, including dry eye discomfort, dry eyes, burning/stinging, itching, foreign body sensation, photophobia, and pain.
AG-80308 A 0.001% and 0.03% Formulation B provide the best overall safety, tolerability and efficacy profiles.
“We are very encouraged by our data showing that patients are seeing improvement in a variety of signs and symptoms from the phase 1b trial as early as two weeks,” said Madhu Cherukury, CEO of Allgenesis.
“AG-80308 can offer an effective treatment for dry eye patients that can be used long-term without AEs associated with other therapies.”
“With the positive results from the phase 1b trials, we hope to move the program into phase 2, where we will evaluate two doses of AG-80308 in formulation B in vehicles. It will be an ideal drug to treat chronic dry eye patients because of its unique MOA and extraordinary potency,” said Sunil Patel, chief medical officer at Allgenesis.
Allgenesis has started preparations to support the initiation of phase 2 trials in 1Q2024.
About Allgenesis Biotherapeutics
Allgenesis is a clinical stage biopharmaceutical company headquartered in Taipei, Taiwan. The company focuses on research and development of new drugs for the treatment of eye diseases. Current projects in progress 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.
AG-80308 is a first-in-class formyl peptide receptor (FPR) agonist formulated as an aqueous eye drop solution for the treatment of inflammation associated with dry eye disease.
The project was licensed by Allergan (now AbbVie) in May 2020.
For more information on eye disease, see our recent article on five ophthalmology biotechnology companies to look out for.