The ASaP trial is a first-in-man, multi-center, single escalating dose study. The interim results of this trial revealed no drug-related toxicity based on clinical signs, ophthalmic examinations, or laboratory results at any time point monitored in patients treated with up to 150mcg/dose of POT-4. Additionally, no serious adverse events and no identifiable intraocular inflammation were reported.
Preliminary results indicate that intravitreal POT-4 is safe, and the data accumulated so far support the continued investigation of POT-4 for the treatment of both dry and wet age-related macular degeneration (AMD) with larger randomized clinical trials to further define its efficacy profile, the company said.
Cedric Francois, president and CEO of Potentia Pharmaceuticals, said: “These safety data strongly support the further development of POT-4 as a potential treatment for patients with AMD. We believe that the product has significant promise based on these early-stage findings and look forward to further testing of the compound in higher doses as we continue this trial.”