NFL Biosciences is a hit on the stock market today. The shares of this biopharma, which is working on a drug intended for smoking cessation, gained nearly 40%, signing the second best performance on Euronext Paris, behind Deinove. The company located on the outskirts of Montpellier announced last night that its experimental treatment NFL-101, based on natural proteins extracted from tobacco leaves, was going to be tested in India at no cost to it. NFL Biosciences has entered into a partnership with the Indian group Themis Medicare. This will support “the cost of the process, from submission to completion of the study”we read in the press release.
Once the study is approved, the clinical trial will be conducted with 334 smokers. In the event of positive results, Themis will purchase the commercial rights to NFL-101 for India from NFL Biosciences. In addition to a fixed payment, the French company will also receive a double-digit percentage on sales (so more than 10%).
Today, options for quitting smoking are very limited, and focus on nicotine replacement therapy. NFL-101, on the other hand, is devoid of nicotine, a toxic substance.
India has about 267 million smokers. “The Indian smoking cessation market is very largeDacts Ignacio Faus, the general manager of NFL Biosciences. We hope for rapid and accelerated development in India so that NFL-101 can reach the market in a short time. This is our first partnership for the international development of the NFL-101 and we intend to establish more in the future, in developed countries as well as in low and medium countries. revenue. »
Tests in France and Australia
NFL Biosciences, also engaged in the search for a drug against alcohol and cannabis addiction, has made the development of NFL-101 its priority. An international phase II/III study (phase III being the last before potential marketing) has started at the beginning of the year. It concerns 318 smokers, distributed in four centers in France and Australia, over a provisional period of two years.
The main The objectives are to select the best dose and to evaluate the effectiveness of NFL-101 compared to the placebo, for an immediate cessation of smoking and also for a gradual cessation. Endpoints are continuous abstinence for four weeks and six months. The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. Many secondary criteria will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and cravings. Preclinical and phase I studies have already shown a strong reduction in the desire to smoke, without showing any toxicity.
NFL Biosciences had been floated on the stock exchange in the summer of 2021, at a price of 3.80 euros per share, in order to raise funds (5 million euros) to finance clinical trials. Its shares have since lost half their value, in a stock market made more complicated by interest rate hikes by central banks to fight inflation, reducing cash in circulation and raising fears of a recession. . Because of geopolitical tensions, and the war in Ukraine in particular, they prefer to be invested in defensive companies, such as those in health (excluding biotechs and innovative companies, considered too risky because they are not yet making sales).