Louisville, Ky. – Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), announced today that it successfully completed its Phase I ASaP (Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration) clinical trial for the company's leading drug candidate, POT-4.
The ASaP trial was an open label, first-in-man, multi-center, single escalating dose study. The primary safety endpoint of this trial was achieved and the drug was well tolerated by all subjects at all doses tested, based on clinical signs, ophthalmic examinations, and laboratory results. No drug-related serious adverse events and no identifiable intraocular inflammation were reported. Additionally, significant sustained levels of POT-4 were consistently measured via serum analysis in subjects receiving the highest dose studied. The current POT-4 formulation is expected to provide sustained therapeutic ocular levels of the drug for several months following a single injection.
The data accumulated so far support the implementation of a comprehensive Phase II clinical program to further define the safety, efficacy and pharmacokinetic profile of POT-4 as a treatment for both dry and wet AMD.
"The safety and pharmacokinetic data strongly support the further development of POT-4 as a first-in-class treatment for patients with AMD," said Cedric Francois, President and CEO of Potentia Pharmaceuticals. "We believe that POT-4 has significant promise based on these early-stage findings and look forward to further testing of POT-4 in this disease, which is so prevalent and devastating to those affected by it."