Nicox SA has screened the first patient in its phase 3b trial evaluating NCX 470 for the treatment of patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Refresh me on the company.
Headquartered in Sophia Antipolis, France, Nicox is an international ophthalmology company focused on developing solutions for vision management and ocular health.
Its current key areas of focus include:
- Glaucoma
- Allergic conjunctivitis
- Dry eye disease (DED)
However, the company is currently funded exclusively—through June 2024—on the development of its lead clinical product candidate: NCX 470.
Now NCX-470.
This novel nitric oxide (NO)-donating bimatoprost formulation features intraocular pressure (IOP)-lowering effects of NO and prostaglandin analogs (PGAs).
Talk about NO.
NO possesses small, naturally-occurring signaling properties that play a critical role in IOP regulation via the activation of soluble guanylate cyclase (sGC).
And what about PGAs?
PGAs are considered one of the widely used, convenient, and effective classes of drugs as an initial therapy for lowering IOP in OAG and OHT patients.
Note: Branded versions of bimatoprost are already readily available from Allegan, an AbbVie company:
So why not just use PGAs in this eye drop?
Per Nicox, NO provides “additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action [MOA] to that of PGAs.”
To be more precise, this NO-bimatoprost combination contains a dual mechanism of action that, according to the company, has been clinically proven to achieve superior IOP-lowering.
Let’s talk about this previous data.
In September 2021, exploratory nonclinical in vivo studies evaluating the potential protective effects of NCX 470 for the retina and optic nerve head.
Investigators reported that the eye drop demonstrated retinal cell protection by improving “ocular perfusion and retinal function in damaged eyes compared to vehicle.”
Based on this data, the company stated that NCX 470, “may have therapeutic properties over and above lowering of IOP.”
Any other prior trials?
Yes, actually. Two phase 3 trials, in fact: Denali (NCT04630808) and Mont Blanc (NCT04445519).
Back in October 2022, Nicox reported that Mont Blanc—the first of the two studies—achieved its primary objective of demonstrating non-inferiority to latanoprost 0.005%, with NCX 470 exhibiting an IOP lowering of 8.0 to 9.7 mmHg from baseline (vs 7.1 to 9.4 mmHg for latanoprost).
Denali, on the other hand, is currently ongoing in the U.S. and China—with topline data expected in 2025.
To note, both studies were approved to support a potential new drug application (NDA) submission for NCX 470.
Now this new phase 3 trial.
The double-masked, placebo-controlled, phase 3b Whistler study (NCT05938699) is enrolling an estimated 20 healthy participants with OHT who will receive one drop of NCX 470 in a randomized eye (vs an artificial tear placebo) for ~8 days.
The target: to investigate NCX 470’s MOA on aqueous humor parameters, including the trabecular meshwork (TM) outflow and episcleral venous pressure (EVP).
And when can we expect data?
With the trial slated to conclude by December 2024, likely around then. Stay tuned for interim updates in the meantime!