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NFL Biosciences Receives Regulatory Approval to Begin Its Phase 2 TONIC Trial for Smoking and Nicotine Cessation

· Issued by NFL Biosciences SA via Business Wire

Summary by 6ix AI

NFL Biosciences, a French biopharmaceutical company developing immunotherapies for quitting smoking and nicotine, has obtained approvals from France's medicines regulator (ANSM) and an ethics committee for the protection of trial participants (CPP) to begin its Phase 2 (mid-stage) TONIC study of its drug candidate NFL-102.

Key details

  • The trial plans to enroll 310 smokers at several sites in France. Participants are randomly assigned to the drug or a placebo (inactive treatment), and neither they nor the investigators know who gets which. The design is meant to narrow three starting doses to one.
  • The main measure of success is four weeks of continuous abstinence, confirmed by urinary cotinine (a substance the body makes from nicotine, measured in urine).
  • Part A covers the first 40 participants at the Eurofins Optimed Clinical Center in Gières. One dose is then to be dropped based on safety and efficacy data analyzed, after revealing who received what, by an Independent Data Monitoring Committee and the company.
  • Part B covers the next 270 participants: first 150 at about ten centers in France, then an interim analysis by the committee to pick the most effective dose, then 120 more comparing that dose with placebo.
  • NFL Biosciences says its current cash position enables it to fund Part A, and it is actively pursuing efforts to identify strategic and financial partners to ensure the clinical development of Part B.

What’s still pending

  • Enrollment of the first participants is scheduled to begin in November 2026.
  • Analysis and communication of Part A results are expected in April 2027.

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NFL BIOSCIENCES S.A.

  • The TONIC Phase 2 trial evaluating NFL-102 consists of Part A (the first 40 participants) and Part B (the next 270 participants)
  • Enrollment of the first participants (Part A) is scheduled to begin in November 2026
  • Analysis and communication of the results from Part A expected in April 2027

Regulatory News:

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing immunotherapies for smoking and nicotine cessation, announced today that it has obtained the necessary approvals from the French National Agency for Medicines and Health Products Safety (ANSM) and the Committee for the Protection of Human Subjects (CPP) to begin its Phase 2 TONIC study evaluating NFL-102 for smoking and nicotine cessation.

NFL-101 AND NFL-102: TWO DISTINCT IMMUNOTHERAPIES

NFL-101 is designed to reduce neuroinflammation and has demonstrated statistically significant efficacy in a Phase 2 trial in a population defined by an immune biomarker predictive of response, identified in post-hoc analyses. A manuscript presenting these results is currently being submitted to an international peer-reviewed scientific journal. NFL-102, on the other hand, targets a root cause of addiction: alterations in brain plasticity. The TONIC study will now evaluate its efficacy in smoking and nicotine cessation.

TONIC STUDY

The TONIC study plans to enroll 310 smokers in France in a multicenter, randomized, double-blind, placebo-controlled trial. Its adaptive design will allow for the gradual selection of one dose from among three initial doses. The primary endpoint will be continuous abstinence for four weeks, confirmed by urinary cotinine.

Part A

An initial analysis will focus on the first 40 participants, included in the Eurofins Optimed Clinical Center (Gières, 38), and one dose will be eliminated based on safety and efficacy data analyzed—after unblinding—by an Independent Data Monitoring Committee (IDMC) and the company.

The first enrollments are scheduled for November 2026, and the analysis of the results from Part A is scheduled for April 2027. These two milestones will be the subject of dedicated announcements.

Part B

After enrolling an additional 150 participants (50 per arm, randomized between the two selected dose arms and the placebo) at about ten clinical centers in France, an interim analysis conducted by the IDMC will identify the most effective dose, without unblinding the other parties involved in the study. The study will then continue exclusively with this selected dose compared to placebo, with the enrollment of an additional 120 participants (60 per arm, randomized between the selected dose and placebo).

The Company’s current cash position enables it to fund Part A of this TONIC study. The Company is actively pursuing efforts to identify strategic and financial partners to ensure the clinical development of Part B.

About NFL Biosciences: www.nflbiosciences.com

NFL Biosciences is a biopharmaceutical company based in the Montpellier region (France) that is developing a portfolio of innovative immunotherapies for smoking cessation and nicotine dependence. The Company is developing two drug candidates derived from tobacco leaves, NFL-101 and NFL-102, which target complementary biological mechanisms involved in addiction. NFL-101, whose efficacy and safety have been evaluated in a Phase 2 trial, is being developed using a precision medicine approach based on a biomarker that identifies patients most likely to respond to treatment. It is currently preparing for a Phase 3 trial and is intended to be the subject of a licensing agreement. NFL-102 represents a second immunotherapeutic approach and enters Phase 2 to evaluate its efficacy, select the optimal dose, and characterize responders. Both treatments are designed to be administered as just two subcutaneous injections one week apart.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 - ALNFL).

View source version on businesswire.com: https://www.businesswire.com/news/home/20261021927272/en/

NewCap
Investor Relations / Media Relations
Mathilde Bohin / Jérémy Digel
Tel.: 01 44 71 94 94
E-mail : nfl@newcap.eu

NFL Biosciences
Bruno Lafont
Tél.: 04 11 93 76 67
E-mail : info@nflbiosciences.com

View original source (Business Wire)NFL Biosciences SA on 6ix

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