- As planned, 333 patients have been randomized at end of
December 2023 across 11 clinical centers in the United
States
- This major milestone confirms the announced availability of
the first results of the study for the end of the second quarter of
2024
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a
clinical-stage biopharmaceutical company specializing in the
development of treatments for brain disorders, today announces to
have reached a key milestone by successfully completing the
recruitment of 333 patients suffering from cannabis addiction in
its Phase 2b clinical study with AEF0117.
AEF0117 is the first of a new class of proprietary drugs
developed by Aelis Farma, the Signaling Specific inhibitors of the
CB1 receptor of the endocannabinoid system (CB1-SSi). The ongoing
multicenter Phase 2b study aims to demonstrate the effectiveness of
this "first-in-class" compound in treating cannabis addiction,
currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the
reference diagnostic manual of mental disorders.
The recruitment and randomization of the 333 study patients were
accomplished across 11 clinical centers in the United States, under
the coordination of Pr. Frances Levin from Columbia University (New
York). The double-blind, placebo-controlled trial involves the
administration of 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 reduces
cannabis consumption by demonstrating an increase in the proportion
of subjects consuming cannabis ≤1 day per week compared to the
placebo. The proportion of patients achieving other levels of
reduced consumption, along with the potential improvement in their
quality of life, will also be examined as secondary endpoint.
Initial results are expected in line with the timeline previously
announced for the second quarter of 2024.
Pr. Frances Levin, the study's principal investigator and
Professor of Psychiatry at Columbia University, commented: “The
successful recruitment of 333 patients, according to the
predetermined schedule, demonstrates the real demand for treatment
experienced by individuals suffering from CUD. We would like to
thank the participants as well as the medical teams of the eleven
centres of this study, for their trust, effort, and dedication to
this important clinical trial. We eagerly await results that could
be a critically important and novel therapeutic intervention for
the treatment of moderate to severe cannabis use disorder.”
To ensure a smooth transition of AEF0117 to the Phase 3 study
after a positive Phase 2b, Aelis Farma initiated, in parallel with
the Phase 2b, a series of toxicology studies required by the
regulatory authorities. Announced last November, the favourable
safety profile observed in this context validates the positive
observations of the independent Data Safety Monitoring Board (DSMB)
for the initial 115 patients in the Phase 2b study, confirming the
good tolerance of AEF0117 in individuals with cannabis addiction.
Thanks to the completion of these non-clinical developments ahead
of schedule, AEF0117 will be ready to enter the Phase 3 clinical
study for cannabis addiction at the end of a positive Phase 2b,
subject to regulatory approval of the Phase 3 design.
Pier Vincenzo Piazza, CEO of Aelis Farma, concluded: “We
are delighted to announce the completion of the recruitment phase
of this study, which is the largest ever conducted for the
treatment of cannabis addiction. This important milestone, once
again, demonstrates Aelis Farma's ability to deliver and meet
deadlines. We are determined to continue our roadmap with the goal
of offering an effective treatment against cannabis addiction, a
condition affecting an increasing number of people worldwide. In
this regard, I would like to thank Professor Levin, the
investigators, the Aelis team, and naturally, the participants to
the study for their trust and dedication to the development of this
promising new treatment.”
The Phase 2b study is an integral part of the clinical program
for AEF0117, which received USD 7.8 million of total funding from
the National Institutes of Health (NIH), with USD 4.5 million
allocated in late 2021 for the current development phase.
Previously, a Phase 2a study, conducted by Pr. Margaret Haney
(Columbia University, NY) in volunteers with cannabis addiction,
provided initial evidence of the efficacy of AEF0117 with a
favourable safety profile.
Based on encouraging Phase 2a results, Aelis Farma entered into
an exclusive option and license agreement in 2021 with Indivior
PLC, a leading pharmaceutical group in addiction treatment, for the
development and commercialization of AEF0117 as a treatment for
disorders due to excessive cannabis use. As part of this agreement,
Aelis Farma has received already USD 30 million (option payment).
If Indivior exercises the license option at the end of the Phase 2b
(H2 2024), Aelis Farma will receive a USD 100 million license fee
and up to USD 340 million in additional payments contingent on the
achievement of development, regulatory and commercial milestones as
well as, royalties on net sales of AEF0117 ranging between 12% and
20%. Following the exercise of the option, all development,
registration, and commercialization costs of AEF0117 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 activity made by the team led by Dr. Pier Vincenzo
Piazza, the Company’s CEO, when he was the director of the
Neurocentre Magendie of the 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), currently being tested in a phase 2b
study in the United States; 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 20 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/20240109064721/en/
AELIS FARMA Pier Vincenzo Piazza CEO
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.fr +33
1 44 71 00 15
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