- The main objective of this phase 2B study was to demonstrate
that AEF0117 reduces cannabis use and to determine the endpoints as
well as the optimal dosage of AEF0117 for use in future
studies.
- AEF0117 was well tolerated, and no safety concerns were
identified.
- The primary and secondary endpoints, which measured the
percentage of participants who reduced the number of days of use
per week within a specified threshold: ≤1 day per week (primary
endpoint); ≤2 days per week; and full abstinence, were not met by
AEF0117. The placebo effect was surprisingly very small for these
endpoints.
- At the highest dose of 1 mg/day AEF0117 showed consistent
trends of a quantitative reduction in the overall amount of
cannabis used per week, some of which were statistically
significant in participants with moderate CUD.
- Currently, Aelis Farma is investigating these quantitative
improvements further in order to determine the best course of
strategic and regulatory actions.
- Indivior has communicated that it does not intend to
exercise the option on AEF0117 before seeing the additional
analysis of the clinical data.
Two videoconferences will be held today,
September 4, 2024, the first in French at 10:30 am CEST and
the second in English at 3:30 pm CEST / 9:30 am EDT.
To participate, please register
here:
Videoconference in French
Videoconference in English
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a
clinical-stage biopharmaceutical company specializing in the
development of treatments for brain diseases, today announces
results from the clinical Phase 2B trial conducted by Aelis Farma
with AEF01171, evaluating its efficacy and safety in
treatment-seeking participants with moderate to severe Cannabis Use
Disorder (CUD) that used cannabis ≥5 days/week at baseline. In this
study population, 82% of the participants had severe CUD.
The purpose of this pioneering phase 2B trial was to show that
AEF0117 lowers cannabis use and to determine the endpoints and
optimal dosage of AEF0117 for use in future studies. Three doses of
AEF0117 (0.1, 0.3, 1mg once a day for 12 weeks) were evaluated and
several endpoints (primary, secondary, and exploratory) measuring
changes in cannabis use and their consequences for the participants
were analysed.
AEF0117 was well tolerated, and no safety concerns were
observed. The type and frequency of adverse events were similar
across all treatment groups including placebo.
The primary endpoint, the proportion of participants who reduced
their cannabis use to ≤1 day per week, as well as secondary
endpoints measuring the proportion of participants reaching either
complete abstinence or reducing cannabis use to ≤2 day per week did
not differ from placebo. It is noteworthy that there was a very low
placebo effect for these endpoints, suggesting that CUD
participants in this study may be resistant to change the number of
days per week of use.
At the highest dose of AEF0117 (1 mg/day), encouraging and
consistent positive trends were observed on several quantitative
endpoints measuring the total amount of cannabis used, including
the urine concentrations of the THC metabolite THC-COOH, an
objective measure of cannabis use. Some of these decreases were
statistically significant in participants with moderate CUD. These
data are in agreement with the positive results of the phase 2A2,
in which only quantitative endpoints were measured, and the largest
population of participants had a moderate CUD.
At the end of the treatment period, AEF0117 (1 mg/day) improved,
with a nearly statistically significant effect, anxiety and
depression scores on the Hamilton scales and sleep quality. These
findings suggest that AEF0117's pharmacological profile differs
from that of CB1 receptor antagonists, including rimonabant, which
have been shown to increase anxiety and depression.
These data indicate that AEF0117 is pharmacologically active,
providing a supplementary validation of the new pharmacological
class developed by Aelis Farma, the “Signalling Specific Inhibitors
of the CB1 receptor (CB1-SSi)”.
Aelis Farma continues to explore the results of the study
further in order to determine the best course of strategic and
regulatory actions.
This clinical Phase 2B study is part of the strategic
collaboration between Aelis Farma and Indivior, which includes an
exclusive option for Indivior to license the global rights to
AEF0117, a first-in-class synthetic Signaling Specific Inhibitor
(“SSI”) engineered to inhibit the cannabinoid type 1 (“CB1”)
receptor (“CB1-SSI”).2 Indivior has communicated Aelis Farma that
it does not intend to exercise the option on AEF0117 before seeing
the additional analysis of the clinical data.
About AEF0117 and the Clinical Phase 2B Study
The Phase 2B study is part of Aelis Farma clinical development
program of AEF0117.
The completed Phase 2B trial (NCT05322941) performed by Aelis
Farma was a randomized, double-blind, placebo-controlled, 4-arm,
parallel-group, prospective, multicentre study (“Effect of AEF0117
on Treatment-seeking Patients with Cannabis Use Disorder (CUD)
(SICA2)”).1 Participants were recruited across eleven clinical
centres throughout the United States. Three hundred thirty-three
treatment-seeking participants with moderate to severe CUD were
treated once daily for 12 weeks, with either 1.0mg, 0.3mg, and
0.1mg of AEF0117 or placebo. The primary endpoint was the
proportion of participants who reduced their cannabis use to ≤1 day
per week. Secondary endpoints included improvement in complete
abstinence, the proportion of participants with modest cannabis use
(≤2 days per week), a quantitative improvement in quality of life,
and overall reduction of days of cannabis use per week. Exploratory
endpoints included reduction in cannabis craving and in the amount
of cannabis consumed per day of use, as measured by the amount of $
spent on cannabis per day.
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.2 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 related disorders, that has just completed a Phase 2B
study in the United States in CUD, 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, which
results are expected in Q4-2024. 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. The different drugs developed by the company belong to
the same general pharmacological class, the CB1-SSi, but have
distinct functional effects allowing to target different types of
dysregulations 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.
Upcoming communication:
- Half-year financial results 2024: September 26, 2024
(after market close)
References:
- National Library of Medicine (U.S.) (2022, April). Effect of
AEF0117 on treatment-seeking patients with cannabis use disorder
(CUD) (SICA2). Identifier NCT05322941
https://www.clinicaltrials.gov/study/NCT05322941
- Haney M, Vallée M, Fabre S, Collins Reed S, Zanese M,
Campistron G, Arout CA, Foltin RW, Cooper ZD, Kearney-Ramos T,
Metna M, Justinova Z, Schindler C, Hebert-Chatelain E, Bellocchio
L, Cathala A, Bari A, Serrat R, Finlay DB, Caraci F, Redon B,
Martín-García E, Busquets-Garcia A, Matias I, Levin FR, Felpin FX,
Simon N, Cota D, Spampinato U, Maldonado R, Shaham Y, Glass M,
Thomsen LL, Mengel H, Marsicano G, Monlezun S, Revest JM, Piazza
PV. Signaling-specific inhibition of the CB1 receptor for cannabis
use disorder: phase 1 and phase 2a randomized trials. Nat Med. 2023
Jun;29(6):1487-1499.
https://doi.org/10.1038/s41591-023-02381-w
***
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
24, 2024, under number R.24-004.
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240903187915/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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