NFL Biosciences, a biopharmaceutical company developing botanical drugs for the treatment of addictions and addictions, has announced the approval of a Phase 2 study to evaluate the efficacy and safety of its NFL-101 treatment as a therapy for smoking cessation, by the Human Research Ethics Committee (HREC) in Australia.
NFL-101 is a clinically developed botanical drug candidate composed of natural proteins extracted from tobacco leaves, and devoid of nicotine. NFL-101 was the subject of the filing of two families of patents, as well as preclinical studies and a Phase I which demonstrated a strong reduction in the desire to smoke, without exhibiting toxicity.
NFL-101 is derived from a subcutaneous desensitization treatment that had been developed by the Pasteur Institute against tobacco allergies in workers in tobacco factories. Used without prescription by a French doctor on more than 10,000 smokers, the repositioned Pasteur extract had shown promising results which were supported by a retrospective study. NFL-101 is a standardized version for pharmaceutical use. A Phase 2 study of 204 patients was approved by the ANSM in May 2020, but blocked in its execution by the health crisis.
The study now announced will be conducted in Australia, a country largely spared by the Covid-19 pandemic, which will promote its progress over a planned period of 24 months. In addition, the Australian Therapeutic Goods Administration (TGA) is closely aligned in its regulatory approaches with those of international agencies, which would allow the data collected to be used with the EMA (European Medicines Agency) and the FDA (Food & Drug Administration, United States) in addition to the TGA.
« While smoking still kills more than 8 million people per year worldwide, NFL-101 is a natural drug candidate that has shown its ability to change the smoker’s relationship with cigarettes, while presenting a novel treatment profile. . More than ¾ of smokers assisted fail in their attempt to quit. NFL-101 will make it possible to offer smokers real support in the treatment of their addiction and potentially represents a major advance in the field of the fight against this particularly stubborn addiction ”declared Bruno Lafont, Deputy Managing Director and co-founder of NFL Biosciences.
A study of significant size and with the main approved criteria.
The Phase 2 clinical trial, dubbed CESTO II, will have 318 smokers, aged 18 and over. The trial will be multicenter, randomized, double-blind versus placebo. It will include 3 arms (two dose arms and one placebo arm) and patient follow-up will be 12 months (CESTO2, NCT04571216).
The main objectives of CESTO II are to select the best dose and to assess the effectiveness of NFL-101 compared to placebo, for immediate cessation of smoking and also for gradual cessation. The endpoints are continuous abstinence for 4 weeks (FDA) and 6 months (EMA). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. Many secondary endpoints will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and craving.
The administration of the treatment consists of a first subcutaneous injection, concomitant with an attempt to quit smoking, followed a week later by a second injection. The goal is to facilitate success in the days following a quit attempt, a period known to be of the utmost importance in greatly increasing the chances of long-term success. An optional injection may be offered at month three as well as at month six for patients who were not abstinent on these dates and who undertake to make a new attempt to stop at each injection. The aggregate efficacy at the end of treatment, after two, three or four injections will also be measured, assessing the potential for personalization of the treatment.
Source and visual: NFL Biosciences