(Photo credits: Pixabay – fernando zhiminaicela)
(AOF) – Nicox jumped 10% to 1.84 euros. This morning, the company announced the publication of the results of the Dolomites Phase 2 clinical study of NCX 470 in patients with open-angle glaucoma or ocular hypertension in the Journal of Glaucoma, the official journal of the World Glaucoma. Association. Two Phase 3 clinical studies of NCX 470 are currently underway.
The Dolomites study was a Phase 2, dose-finding clinical study comparing three concentrations of NCX 470 (0.021%, 0.042%, and 0.065%) to latanoprost ophthalmic solution 0.005% in 433 patients with open-angle glaucoma or ocular hypertension.
Consistent with previously reported key Dolomites study results, NCX 470 showed statistical superiority over latanoprost at all time points measured on day 28 with maximum improvement in intraocular pressure (IOP) reduction greater than that observed with latanoprost.
All NCX 470 concentrations tested were statistically non-inferior to latanoprost and the dose-response relationship of NCX 470 showed that each increment in concentration improved IOP reduction. NCX 470 was shown to be safe and well tolerated, with no serious treatment-related adverse events or evidence of systemic side effects.
“Data from the Phase 2 Dolomites study presented by Dr. David Wirta to the American Glaucoma Society in February 2020 demonstrate the potential of NCX 470, a monotherapy with a dual mechanism of action, as a new gold standard treatment for reduction of intraocular pressure in patients with open glaucoma or ocular hypertension,” said Doug Hubatsch, Chief Scientific Officer of Nicox.
“We are pleased that the results of this phase 2 study are published in a peer-reviewed journal of the international glaucoma scientific community. We are awaiting the results of subsequent Phase 3 studies of NCX 470, the Mont Blanc and Denali studies, which are testing a higher dose of NCX 470 determined based on the results of the initial part of the Mont Blanc study which allowed selecting this dose.”
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit/risk ratio with several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.