Nicox said Denali is a 3-month phase 3 trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, vs the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The trial, which will also include a long-term safety extension, is expected to randomize 650+ patients, at approximately 50 clinical sites in the United States and China, with a majority to be recruited in the United States. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the United States and China.

Nicox also announced the selection of the 0.1% dose of NCX 470 for the Mont Blanc phase 3 trial following the completion of the adaptive portion of this clinical trial. As is customary for adaptive-design trials, to maintain the integrity of the trial, no data from the adaptive portion of the trial will be disclosed until the completion of the trial. NCX 470, Nicox’s lead clinical product candidate, is a novel second-generation nitric oxide (NO)-donating bimatoprost analog.

“Selecting the dose for the remaining phase 3 trials is an important milestone in the development of this high potential, novel molecule, and progress on the overall program continues to meet our expectations,” said José Boyer, PhD, vice president and head of clinical development at Nicox.