(News Bulletin 247) – The biopharmaceutical company announced results from its phase 2 clinical study highlighting the efficacy of NFL-101 for smoking cessation comparable to that of Champix, but without its side effects. However, the stock is falling on the Paris Stock Exchange.

NFL Biosciences is on track to announce results from a phase 2 clinical trial for Cesto II, its program testing NFL-101, its most advanced drug candidate for smoking cessation.

The company specializing in the treatment of dependencies and addictions announced this Monday that the fundamental objectives of this Cesto II Phase 2 study (intermediate stage of clinical trials) “have been achieved”, and that the potential of NFL-101 as a smoking cessation treatment has been “confirmed”.

Initiated in September 2021, Cesto II is a double-blind phase II clinical study comprising three “arms” (a group of patients with dose 1, another group of patients with dose 2 and a final group receiving a placebo), and which was conducted in nine clinical centers in France on 318 smokers wishing to quit smoking.

Effectiveness comparable to that of Champix

This study demonstrates an effect that compares favorably with current treatments, with efficacy comparable to that of Champix – a drug marketed by Pfizer – but without the side effects commonly associated with this treatment, such as insomnia, abnormal dreams and thoughts, nausea, other gastrointestinal complaints or depressive events.

NFL Biosciences also confirms that its potential treatment NFL-101 matches the efficacy of the best current treatment with just two administrations versus two daily doses for twelve weeks.

The company adds that the efficacy of NFL-101 one year after stopping treatment is equivalent to that of nicotine replacement therapy just 3 months after stopping treatment.

“NFL-101 confirms its disruptive potential by equaling the efficacy of the best current treatment with only two administrations compared to two daily doses for twelve weeks, all without side effects that could limit its administration. The efficacy rates obtained allow us to confidently envisage success in Phase III,” explains Bruno Lafont, Deputy CEO and co-founder of NFL Biosciences.

The company recalls that NFL-101 has already been tested in two clinical studies: a phase I study (first stage of clinical trials), called Cesto, which confirmed safety and a phase IIa study, Precesto, which confirmed the ability to significantly reduce the satisfaction provided by cigarettes in smokers not wishing to quit.

“Generally satisfactory” results

On the Paris Stock Exchange, NFL Biosciences is currently down 9.5% at around 3:00 p.m., after having gained more than 13% in early trading on Monday morning. Today’s announcement was a pretext for profit-taking on a stock that had gained 77.7% at the close on Friday.

“The drop can be justified by profit-taking on a very retail stock (held by individual investors, Editor’s note) with phase II results that are satisfactory and sufficient to move to phase III but not exceptional,” explains Invest Securities.

“The black spot remains the absence of statistical significance, even if it is very close and that in the context of a phase III on numbers a priori three times larger should not pose a problem. The doubts are partly lifted with an encouraging efficiency but there is still a way to go and long negotiations to be conducted with potential partners to sign a license agreement”, continues the research office.

“There is therefore nothing alarming about NFL Biosciences, which has all the cards in hand to hope to negotiate a partnership,” concludes Invest Securities. The research firm confirmed its buy recommendation and raised its price target from 5.5 euros to 8.8 euros, after the announcement of the results of the Cesto II study.

“A considerable potential market”

Let’s recall that with NFL-101, the biopharmaceutical company hopes to help the millions of people around the world who want to stop smoking. And it intends to attack the market for traditional patches and other chewing gums.

“Its unique mechanism of action, distinct from current treatments, and its punctate administration, would allow it to be used alone or at the initiation of any treatment with nicotine replacement therapy or Champix. NFL-101 would thus have access to a considerable potential market, significantly greater than that of Champix, which had exceeded $1 billion in annual sales, because Champix could not be taken with nicotine replacement therapy, which targets the same nicotinic receptors in the brain,” NFL Biosciences said in its press release today.

In parallel, NFL Biosciences is developing natural drug candidates for the treatment of two other addictions: cannabis-related addictions (NFL-201) and alcohol-related addictions (NFL-301). NFL-201 is a mixed extract of tobacco leaf proteins and cannabis proteins (without nicotine, THC or CBD) while NFL-301 aims to reduce alcohol consumption based on a plant extract from traditional Chinese medicine.