Source: News by Formosa Pharmaceuticals
Formosa Pharmaceuticals, Inc. (TWO.6838) and AimMax Therapeutics, Inc. (United States) report successful top-line results from CPN-301, the first of two pivotal Phase 3 clinical studies of APP13007, a novel ophthalmic nanosuspension formulation of a potent corticosteroid, clobetasol propionate(0.05%), for the treatment of inflammation and pain after cataract surgery.
CPN-301 was a randomized, double-masked trial in the United States of APP13007 versus matching placebo (1:1 ratio) in 378 subjects following cataract surgery. The primary endpoints are complete and sustained resolution of ocular inflammation and pain after cataract surgery. Treatment with an APP13007 eyedrop twice daily for 14 days met the two primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo.
There were 26.5% of subjects who showed sustained anterior chamber cell (ACC) count = 0 (inflammation free) from post-operative day 8 (POD8) through POD15 in the APP13007 arm as compared to 5.1% in the placebo arm (p<0.001). A total of 58.6% of subjects had ACC count = 0 on POD15 following APP13007 treatment as compared to 15.7% following placebo treatment (p<0.001).
Sixty-eight percent (68.0%) of subjects showed sustained ocular pain grade = 0 (pain free) as early as POD4 through to POD15 in the APP13007 arm as compared to 23% in the placebo arm (p<0.001). A total of 77.3% of subjects on APP13007 were ocular pain free at POD4 as compared to 43.7% on placebo (p<0.001).
APP13007 treatment was well tolerated with a safety profile similar to that of placebo. There were no serious adverse events, and the treatment-emergent adverse events were mainly ocular events commonly seen after cataract surgery. Both the APP13007 and placebo treatments had comparable profiles of change in intraocular pressure (IOP) from baseline.
"The data from Study CPN-301 demonstrate the clear benefits of treating patients after cataract surgery with APP13007 accompanied by a reassuring placebo-like safety profile," said AimMax Therapeutics' Chief Medical Officer, Derek Nunez, M.D. "We are extremely pleased to have successfully completed Study CPN-301 over a challenging pandemic period and to have achieved superiority for APP13007 in both primary efficacy endpoints, paving the way for an NDA submission pending the second Phase 3 trial results," said AimMax Therapeutics' Chief Executive Officer, Laurene Wang, Ph.D.
"We are extremely encouraged to observe the clinical outcome of this novel formulation of clobetasol propionate and are appreciative of the painstaking efforts of our clinical team at AimMax Therapeutics and the clinical investigators for achieving this latest milestone of APP13007," said Erick Co, Ph.D., Formosa Pharmaceuticals' Chief Executive Officer.