NFL BIOSCIENCES: Inclusion of the first volunteer in the PRECESTO study
2023年2月23日 - 2:00AM
NFL BIOSCIENCES: Inclusion of the first volunteer in the PRECESTO
study
NFL BIOSCIENCES: Inclusion of the first volunteer in the
PRECESTO study, which aims to demonstrate the complementarity of
NFL-101 with other smoking cessation treatments
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company
developing botanical medicines for the treatment of addiction,
announces the inclusion of the first volunteer in its PRECESTO
clinical trial, designed to
evaluate the complementarity of its NFL-101 treatment as a smoking
cessation therapy with other smoking cessation treatments, notably
nicotine replacement therapies.
This Phase IIa clinical study, entitled
PRECESTO, was approved by the French National Agency for the Safety
of Medicines and Health Products (ANSM), and received a positive
opinion from the French Committee for the Protection of Individuals
(CPP) in November 2022. Its main objective is to validate the
complementarity of NFL-101 with other smoking cessation treatments,
in particular nicotine substitutes (transdermal patches, tablets,
gum, inhalers and nicotine sprays), with a view to developing an
innovative treatment method combining NFL-101 with other smoking
cessation methods. PRECESTO is being implemented at Eurofins
Optimed's clinical research center in Gières, in the Grenoble
area.
In this new treatment method, for which a patent
was filed in October 2022, the administration of NFL-101 prior to
the quit attempt aims to break the link between cigarettes and the
satisfaction they provide, and to reduce the desire to smoke.
Smokers can then focus on their quit attempt and manage their
nicotine withdrawal symptoms (irritability, nervousness, anxiety,
etc.) with the help of other smoking cessation treatments,
including nicotine replacement therapies.
The PRECESTO study compares the ability of
NFL-101 to reduce cigarette satisfaction and craving with placebo.
It is a randomized, double-blind study that will include a total of
34 smokers who do not wish to quit and have high smoking
satisfaction in a cross-over design. Each subject is his or her own
control and receives either NFL-101 or placebo randomly and
alternately at the beginning of each of two periods during which he
or she assesses satisfaction with cigarettes and craving for
cigarettes using international questionnaires. The periods are each
one month long. The Modified Cigarette Evaluation Questionnaire
(mCEQ) is used as the main instrument. It measures satisfaction
with smoking, psychological reward, aversion, pleasant sensations
in the airways, and reduction in craving. Results of the PRECESTO
study are expected in the third quarter of 2023. This study is
expected to increase the attractiveness of NFL-101 to
pharmaceutical companies marketing smoking cessation drugs and who
may be interested in licensing it.
Bruno Lafont, Chief Operating Officer and
co-founder of NFL Biosciences, said: "PRECESTO complements the
ongoing CESTO II study (318 smokers, 9 clinical investigation
centers in France) designed to validate the efficacy of NFL-101 as
a smoking cessation therapy. 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. The
global market for smoking cessation drugs is estimated to be close
to USD 6 billion, with a growth rate of around 6% in the years to
come.”
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
disorders.
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 – nflbio@calyptus.net - +33 1 53 65 68 68
- 20230222_NFLBiosciences_1er-volontaire-PRECESTO_EN_DEF
NFL Biosciences (EU:ALNFL)
過去 株価チャート
から 5 2024 まで 6 2024
NFL Biosciences (EU:ALNFL)
過去 株価チャート
から 6 2023 まで 6 2024