Nicox screens first patient in Whistler Phase 3b trial of NCX 470 in glaucoma

NCX 470, a novel NO-donating bimatoprost eye drop, is currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.(Image courtesy of Adobe Stock)

Nicox SA announced the first patient has been screened in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in IOP lowering.

According to the company, NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is its lead product candidate in Phase 3 clinical development for IOP lowering in patients with open-angle glaucoma or ocular hypertension.¹

Doug Hubatsch, executive vice president and chief scientific officer of Nicox, pointed out in the company’s news release the model the company is using to investigate the effects on aqueous humor outflow is well established. He noted Nicox is working with one of the experts in this field, Arthur Sit, MD, at the Mayo Clinic.

“The data from this trial is expected to provide further evidence of the dual mechanism of action of NCX 470 as we should be able to tease out parameters related to how the nitric oxide and the prostaglandin analog components of NCX 470 function,” he said in the news release.

According to the company, its Whistler Phase 3b trial will enroll ~20 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study which will investigate the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. The company noted that each subject will participate in the trial for ~8 days and will provide insight into the mechanism of action of NCX 470. The trial is expected to take approximately 1 year to complete.¹

NCX 470, a novel NO-donating bimatoprost eye drop, is currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, were unveiled in October 2022. The second Phase 3 clinical trial, Denali, is currently ongoing, and the results are expected in 2025 based on current recruitment rates. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the United States and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics.¹

Moreover, the company noted it is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470. The company noted in its news release it is pursuing licensing discussions which could extend the cash runway. In parallel, the company said in the news release it is exploring multiple strategic options and is also discussing with its creditors to restructure its debt.

Reference

1. Nicox Announces First Patient Screened in the Whistler Phase 3b . www.globenewswire.com/news-release/2023/12/18/2797468/0/en/Nicox-Announces-First-Patient-Screened-in-the-Whistler-Phase-3b-Trial-of-NCX-470-in-Glaucoma.html. Published December 18, 2023. Accessed December 18, 2023.