For Kepler Cheuvreux, the experimental treatment of Nicox against glaucoma “must improve its efficacy profile”


Posted Jan 10, 2023, 3:32 PMUpdated Jan 10, 2023, 3:34 PM

Nicox has been kept out of the rebound in biotechnology stocks since the start of the year. Today, the shares of this company, one of the stars of its sector in France twenty years ago, are still losing around 2%, at 1.094 euros, while Kepler Cheuvreux has lowered its target price to 2, 7 euro. The upside potential on the stock market is still more than 100%, of course, but before looking back on the file, the financial analyst Clémence Thiers rather saw the price of this specialist in ophthalmological treatments – not far from falling into “penny stock – be multiplied by 7 compared to the historical lows on which it has been evolving for more than two months; she was aiming for a target of 7 euros.

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“In October 2022, Nicox published initial data from the Phase III ‘Mont Blanc’ study evaluating NCX 470 in the treatment of open-angle glaucoma and ocular hypertension.recalls Clémence Thiers. Although the study met the primary endpoint of non-inferiority to latanoprost (the standard of care) in lowering IOP [la maladie se caractérise par élévation de la pression intraoculaire], it failed to demonstrate statistically significant superiority in a phase III study. »

Which means that “if these clinical results meet the approval criteria in the United States, we believe that it will be more difficult to convince the medical community”writes the analyst in a note which, accordingly, expects “reduced market share”, 6% against 15% initially anticipated. It expects a peak in sales of 86 million euros.

The company, well aware of the problem, plans to initiate two phase IIIb studies in the first half of this year to evaluate the protective effects of NCX 470 on the retina, in order to create strong differentiation and generate interest. commercial.

A phase III in China

A second phase III study, dubbed “Denali” (Nicox’s clinical trials in glaucoma have mountain names), to test NCX 470 still as a treatment for open-angle glaucoma, but this time in China in addition to the United States. United, started in partnership with its Chinese partner Ocumension and its results are expected in 2025. But, as Kepler analyst Cheuvreux points out, “Because the design of the phase III ‘Denali’ trial is very similar to that of the ‘Mont Blanc’ trial, the results are likely to be similar. »

As part of this study, approximately 670 patients (slightly less than for “Mont Blanc) are to be “randomized” at approximately 60 clinical sites in the United States and China, with approximately 80% of patients recruited in the United States and the remaining 20% ​​in China. The first patient was recruited in China just over a year ago. The “Denali” study also includes a long-term safety study lasting twelve months.


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