- The last patient in the clinical phase 2b trial with AEF0117
for the treatment of cannabis use disorder has completed its last
medical visit, paving the way for the release of study results in
the third quarter of 2024
- This achievement is a key milestone in the clinical
development of AEF0117, which could represent the first treatment
of cannabis use disorder
- Aelis Farma's partner Indivior retains a $100 million
license option, exercisable within 90 days of promising phase 2b
results and FDA feedback at future End-of-Phase 2 (EOP2)
meeting
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a
clinical-stage biopharmaceutical company specializing in the
development of treatments for brain diseases, is pleased to
announce today a significant milestone in the clinical development
of AEF0117: the last patient visit in the clinical phase 2b study,
which included 333 individuals seeking treatment for cannabis use
disorder (CUD), has been completed.
AEF0117 represents a novel class of drugs developed by Aelis
Farma, the Signaling-Specific inhibitor of the CB1 receptor
("CB1-SSi"). This phase 2b multicenter study aims to demonstrate
the efficacy and safety of this "first-in-class" compound in
treating cannabis addiction, currently defined as CUD in the DSM-5,
the reference diagnostic manual of mental disorders.
This significant advancement marks the conclusion of clinical
data collection and the start of in-depth analysis. The company
confirms its intention to announce the study results in the third
quarter of this year.
Pr. Frances Levin, the study's principal investigator and
Professor of Psychiatry at Columbia University, comments:
"Completion of the last patient, last visit is a crucial step
towards unveiling the potential efficacy of AEF0117 as a treatment
of cannabis addiction. This milestone marks the end of data
collection and the beginning of in-depth analysis. We eagerly await
results that could offer a crucial and innovative therapeutic
alternative for the treatment of cannabis use disorder. We also
wish to thank all the medical teams involved in the study for their
efforts and dedication and send a special thanks to the CUD
participants for their trust and participation to the study.”
AEF0117 has a favorable therapeutic index >13,000 times the
active dose confirmed in long-term chronic oral toxicity studies (6
months in rats and 9 months in dogs) which support the potential
chronic use of AEF0117 in humans without time restriction. In
addition, the lack of adverse effect in juvenile toxicity studies
would support administration of AEF0117 in adolescents, an
important target population in CUD. Finally, the reproductive
toxicology studies show that AEF0117 does not modify embryonic and
embryofetal development.
The successful early completion of the toxicity studies
described above and of additional non-clinical development studies,
positions AEF0117 to enter phase 3 clinical trials for the
treatment of CUD upon positive results of the present phase 2b
clinical trial and regulatory agreement of the phase 3 protocol. To
reach this goal, the company plans to request an end-of-phase 2
(EOP2) meeting with the FDA in the fourth quarter of this year.
Pier Vincenzo Piazza, CEO of Aelis Farma, concludes:
"Completion of the last patient, last visit in the phase 2b study
with AEF0117, the largest study ever performed for a treatment of
cannabis addiction, marks a significant milestone in our clinical
journey and demonstrates our ability to respect timelines announced
to the market. I would like to send heartfelt thanks to all the
persons who have contributed to this significant advancement in
AEF0117's development, the investigators, the patients and the
extremely dedicated Aelis team. We remain committed to our roadmap
for AEF0117 to offer an effective treatment of cannabis addiction,
an increasingly prevalent and worrying condition worldwide."
Phase 2b clinical study with AEF0117 for the treatment of
cannabis addiction
Under the coordination of Professor Frances Levin at Columbia
University (New York) and of Aelis Farma clinical team, recruitment
and randomization of the 333 patients for the phase 2b trial of
AEF0117 at 11 clinical centers in the United States were completed
in December 2023. The last visit for the last patient was completed
mid-April 2024.
Patients received either placebo or one of the three tested
doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3
months. The primary objective of the study is to assess whether
AEF0117 can reduce cannabis use by increasing the proportion of
subjects consuming cannabis ≤1 day per week compared to the
placebo. Secondary endpoints include the proportion of patients
achieving other levels of reduced cannabis use including
abstinence, and potential improvement in their quality of life.
These secondary endpoints, if positive, could potentially serve as
alternative primary objectives for the future phase 3 trials.
The Phase 2b study is part of the clinical program for AEF0117,
which received $7.8 million of total funding from the National
Institutes of Health (NIH), with $4.5 million allocated in late
2021 for the current developmental phase, aiming to ready the
compound to enter phase 3. The remaining $3.3 million were
previously dedicated to help financing phase 1 and a Phase 2a study
with AEF0117. The phase 2a study, conducted by Pr. Margaret Haney
(Columbia University, NY) in volunteers with cannabis addiction,
provided initial evidence of the efficacy of AEF0117 and confirmed
a favorable safety profile.
License Option with Indivior
Based on promising phase 2a results, Aelis Farma entered an
exclusive option and license agreement in 2021 with Indivior UK
Limited, a subsidiary of Indivior PLC, which is a leading
pharmaceutical group in addiction treatment, for the development
and commercialization of AEF0117 as a treatment for disorders due
to excessive cannabis use. Per agreement, Aelis Farma has already
received $30 million (license option fee). Within three months
following the end of phase 2 meeting with the FDA, Indivior will be
able to exercise its license option, triggering the payment of a
$100 million license fee, up to an additional $340 million in
milestone payments contingent upon the achievement of development,
regulatory, and commercial milestones, as well as royalties on net
sales of AEF0117 ranging from 12% to 20%. Following the exercise of
the option, all development, registration, and commercialization
activities for AEF0117 in CUD shall be conducted by Indivior and
those costs will be borne by Indivior.
***
About AELIS FARMA
Founded in Bordeaux in 2013, Aelis Farma is a biopharmaceutical
company that is developing a new class of drugs, the
Signaling-Specific inhibitors of the CB1 receptor of the
endocannabinoid system (CB1-SSi). CB1-SSi have been developed by
Aelis Farma based on the discovery of a natural regulatory
mechanism of CB1 hyperactivity made by the team led by Dr. Pier
Vincenzo Piazza, the Company’s CEO, when he was the director of the
Neurocentre Magendie of INSERM in Bordeaux. By mimicking this
natural mechanism, CB1-SSi appear to selectively inhibit the
disease-related activity of the CB1 receptor without disrupting its
normal physiological activity. CB1-SSi have consequently the
potential to provide new safe treatments for several brain
diseases.
Aelis Farma is currently developing two first-in-class
clinical-stage drug candidates: AEF0117 for the treatment of
cannabis use disorder (CUD), that has just completed a phase 2b
study in the United States with result expected in Q3 2024; and
AEF0217 for cognitive disorders, including those of Down Syndrome
(Trisomy 21), currently in a phase 1/2 study in Spain in people
with Down syndrome. The Company also has a portfolio of new
innovative CB1-SSi for the treatment of other disorders associated
with a dysregulation of the activity of the CB1 receptor.
Aelis Farma draws on the talents of more than 25 highly
qualified employees.
For more information, visit www.aelisfarma.com and follow us on
LinkedIn and Twitter.
ISIN: FR0014007ZB4 Ticker: AELIS B Compartment
of Euronext Paris
Disclaimer
Forward-looking statements
Some information contained in this press release are
forward-looking statements, not historical data. These
forward-looking statements are based on current beliefs,
expectations, and assumptions, including, but not limited to,
assumptions about Aelis Farma's current and future strategy and the
environment in which Aelis Farma operates. They involve known and
unknown risks, uncertainties, and other factors, which may cause
actual results, performance, or achievements, or industry results
or other events, to differ materially from those described or
implied by such forward-looking statements. These risks and
uncertainties include those set out and described in detail in
Chapter 3 "Risk Factors" of Aelis Farma's Universal Registration
Document approved by the Autorité des Marchés Financiers on April
26, 2023, under number R.23-018.
These forward-looking statements are made only as of the date of
this press release and Aelis Farma expressly disclaims any
obligation or undertaking to release any updates or corrections to
the forward-looking statements included in this press release to
reflect any change in expectations or events, conditions, or
circumstances on which any such forward-looking statement is based.
Forward-looking information and statements are not guarantees of
future performance and are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond Aelis Farma's control. Actual results could differ
materially from those described in, or implied or projected by,
forward-looking information and statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240418781685/en/
AELIS FARMA Arsène Guekam Chief Corporate Development
Officer contact@aelisfarma.com
NewCap Dusan Oresansky / Aurélie Manavarere Investor
Relations aelis@newcap.eu +33 1 44 71 94 92
NewCap Arthur Rouillé Media Relations aelis@newcap.eu +33
1 44 71 00 15
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