Following an announcement of restructuring its corporate debt, Nicox SA has named Gavin Spencer, PhD, a veteran biotech executive and long-time company employee, as its new CEO.
Refresh me on this company.
The international ophthalmology company is based in Sophia Antipolis, France, operating as a developer of solutions for vision management and ocular health.
Its current key areas of focus include:
- Glaucoma
- Allergic conjunctivitis
- Dry eye disease (DED)
Its lead candidate: NCX 470. But more on that in a moment …
Back to Spencer; what’s his background?
With over 25 years of executive experience in the life science industry, Spencer started with Nicox in 2005 as a licensing and alliances director.
His background also includes:
- Parkure Ltd, a Scottish-based biotech company dedicated to curing Parkinson’s disease
- Altacor, an ophthalmology specialty pharma company based in the United Kingdom
- (On behalf of Nicox)
- Boots Healthcare International, a pharmaceutical manufacturing company in Great Britain
- Novartis Consumer Health
So what has he been involved in at Nicox?
Per the company, he played key roles in building and managing Nicox’s partnerships, which included “closing agreements with Pfizer, Bausch + Lomb, VISUfarma, and Ocumension Therapeutics.”
And who is he replacing?
Andreas Segerros, who had held the position since June 2022.
And before you ask: No, the company didn’t give specific reasoning for the change, save for stating that the decision was made “following the Board [of Directors’] decision to end the mandate of … Segerros.”
Gotcha. So when is this new position effective?
Immediately—Feb. 29, 2024.
Now on the company front … what’s in the pipeline?
Most recently, Nicox announced in December 2023 that the first patient had been screened for the phase 3b Whistler trial (NCT05938699) evaluating NCX 470, its lead investigational candidate, for the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT).
See our coverage here, including details on two previous phase 3 trials: Denali (NCT04630808) and Mont Blanc (NCT04445519).
That’s exciting! What, exactly, is NCX 470?
An eye drop, to put it plainly.But more accurately, as a novel nitric oxide (NO)-donating bimatoprost formulation, NCX 470 features the intraocular pressure (IOP)-lowering effects of NO and prostaglandin analogs (PGAs).
Note: NO contains small, naturally-occurring signaling properties that are critical in IOP regulation via the activation of soluble guanylate cyclase (sGC).
Break down PGAs for me.
PGAs are widely used, convenient, and effective classes of drugs as an initial therapy for lowering IOP in both OAG and OHT patients.
In fact, branded versions of bimatoprost (from Allegan, an AbbVie company) are already commercially available:
Tell me then: Why aren’t PGAs used in NCX 470?
Nicox previously stated that 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.”
More specifically: This NO-bimatoprost combination contains a dual mechanism of action that, according to the company, has been clinically proven to achieve superior IOP-lowering.
Interesting … now what’s this about debt restructuring?
Nicox also disclosed that it will be restructuring its debt to streamline operations (plus downsizing its Board of Directors, with three members resigning) and extend cash runway.
The goal: focusing resources on the development of NCX 470.
The extension will fund the completion of the trial through November 2024—5 months longer than the company’s previous extension of funding to June 2024.
And as far as data readouts go?
Interim data from the phase 3 Whistler trial should be released later this year, before the study wraps up in December 2024 (per Clinical Trials, that is).
Topline data from the ongoing phase 3 Denali trial (in both the U.S. and China) is expected in 2025.