Potentia completes Phase I age-related macular degeneration trial

Potentia Pharmaceuticals, a biotechnology company, has successfully completed its Phase I ASaP clinical trial for POT-4, the company’s lead drug candidate for the treatment of age-related macular degeneration.

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, said Potentia.

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.

According to the company, 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 age-related macular degeneration (AMD).

Cedric Francois, president and CEO of Potentia Pharmaceuticals, said: The safety and pharmacokinetic data strongly support the further development of POT-4 as a first-in-class treatment for patients with AMD. 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.