NFL Biosciences: Recruitment completed for the PRECESTO study
09 Mayo 2023 - 10:45AM
NFL Biosciences: Recruitment completed for the PRECESTO study
NFL Biosciences: Recruitment completed for the
PRECESTO study
PRECESTO clinical trial to demonstrate the
potential complementarity of NFL-101 with other smoking cessation
treatments: 100% of volunteers recruited and initial results
expected in the third quarter of 2023.
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company developing
botanical drugs for the treatment of addictions, is announcing that
the final recruitments have been completed for the 34
volunteers in its
PRECESTO clinical trial to
evaluate the potential complementarity of its NFL-101 treatment as
a smoking cessation therapy with other smoking cessation
treatments, notably nicotine replacement therapies.
PRECESTO is a proof-of-concept study that aims
to increase the addressable market for NFL-101 by expanding it, by
administering it in combination with other smoking cessation
treatments, in particular nicotine substitutes (transdermal
patches, tablets, gum, inhalers and nicotine sprays). The global
market for smoking cessation drugs is estimated to be close to USD
6 billion1, with a growth rate of around 6% in the years to
come.
After obtaining the necessary regulatory
authorizations to carry out the trial in September 2022, volunteer
recruitment started up in February 2023 and was completed on May 5,
2023. The initial results are expected in the third quarter of
2023. This study could increase the attractiveness of NFL-101 to
pharmaceutical companies, especially those marketing smoking
cessation drugs. Conducted at the Eurofins-Optimed research
institute (Grenoble), PRECESTO compares against placebo the ability
of NFL-101 to reduce the attributes that reinforce smoking, such as
the satisfaction or psychological rewards offered by cigarettes.
The PRECESTO study includes 34 smokers who do not wish to quit and
have high smoking satisfaction.
The joint funding for the PRECESTO study
includes a €200,000 non-refundable grant obtained on January 17,
2023 under “Programme d’Investissement d’Avenir 4” from the France
2030 plan, awarded jointly by the French government and the
Occitanie region. This study complements the CESTO II (phase
II/III) clinical trial to assess the efficacy of NFL-101 as a
smoking cessation treatment. CESTO II includes 318 smokers, whose
recruitment was also completed at the end of April 20232.
Bruno Lafont, Chief Operating Officer, and in
charge of product development: “Our ability to effectively manage
complex projects with a streamlined team is a major asset for NFL
Biosciences. We can be proud of having completed, on time and on
budget, the recruitmens for two clinical trials for NFL-101. With a
very low fixed cost structure, the vast majority of our resources
are allocated to financing clinical trials and therefore serve to
increase the potential value of NFL’s addiction treatment
projects”.
About NFL Biosciences
NFL Biosciences is a biopharmaceutical company
based in the Montpellier area which develops botanical drug
candidates for the treatment of addictions. NFL Biosciences'
ambition is to bring new, natural, safer and more effective
therapeutic solutions to the entire world population, including
low- and middle-income countries. Its most advanced product, called
NFL-101, is a standardized, nicotine free tobacco leaf extract
protected by two patent families. NFL Biosciences intends to offer
smokers who want to quit a natural, safe, easy-to-administer and
personalized alternative. NFL Biosciences is also developing
NFL-301, a natural drug candidate for the reduction of alcohol
consumption and has a drug development project for the treatment of
cannabis use disorder.
The shares of NFL Biosciences are listed on
Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at
www.nflbiosciences.com
Contacts
Bruno Lafont – info@nflbiosciences.com - +33 4
11 93 76 67 Agence
Calyptus – nflbiosciences@calyptus.net - +33 1 53 65 68 68
1 Source: Coherent Market Insights.2 See press release from
April 25, 2023 “NFL Biosciences: 2022 full-year business and
earnings update” available here
- NFLBio_CP_PRECESTO-fin-recrutement_EN_DEF
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