(BFM Bourse) – The company specializing in treatments for brain diseases is collapsing on the Paris Stock Exchange. A clinical trial evaluating its treatment to reduce cannabis consumption did not meet its primary and secondary endpoints.
This is a serious setback for the biopharmaceutical company Aelis Farma, which recently arrived on the Paris Stock Exchange, in February 2022 to be precise. This Bordeaux-based company specializes in treatments for brain diseases.
The company has thus developed drug candidates for the treatment of Down syndrome, or trisomy 21, as well as to combat excessive cannabis consumption.
It is in this last indication that Aelis Fama is experiencing a major blunder this Wednesday. The company announced the results of a phase 2b clinical study, an intermediate stage before phase 3, which is the last step before the potential marketing of a drug candidate. Phase 2b focuses more specifically on the efficacy of the treatment, while phase 2a studies the dosage.
This clinical study therefore evaluated AEF0117, the name of the company’s molecule, to reduce cannabis consumption in patients with CUD, i.e. a “moderate to severe cannabis use disorder”. The approximately 333 patients recruited were consuming cannabis at least five days a week at the time of their inclusion in the trial and 82% of them suffered from “severe grade” CUD.
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No efficacy demonstrated compared to placebo
While the molecule was well tolerated and no safety issues were observed, the study was not a success. AEF0117 did not meet its primary endpoint, measuring, compared to placebo, the proportion of patients reducing their cannabis use to one day per week or less.
The potential treatment also failed to meet secondary endpoints, which measured the proportion of participants who achieved total abstinence and whose cannabis use fell to two days or fewer per week.
In all cases, the results did not show significant differences between AEF0117 and placebo.
“It should be noted that the placebo effect was very small for these outcomes, suggesting that in this study, participants with CUD may be resistant to changing the number of days of consumption per week,” the company says.
“At the highest dose of AEF0117 (1 milligram per day), encouraging and consistent positive trends were observed across multiple quantitative endpoints measuring total cannabis consumption,” including urinary concentrations of THC-COOH, a THC metabolite considered an objective measure of cannabis use,” the company said. “Some of these declines were even statistically significant in participants with moderate CUD,” it added.
Aelis Farma said it would continue to study the results of the study “to determine the best course of strategic and regulatory action.”
A heavy plunge on the Paris Stock Exchange
“This failure should be heavily sanctioned by the market,” Invest Securities wrote in a commentary written before the opening of the Paris Stock Exchange.
After having been reserved for a long time on the downside, the Aelis Farma share price collapsed by 50% on the Paris Stock Exchange around 12:30 p.m.
In a note written in April, Degroof Petercam expected positive results for this clinical study.
Allied with Aelis Farma since 2021, the British-American laboratory Indivior has an option for an exclusive license agreement on AEF0117 on the condition that the phase 2b trial is successful. Which, if so, would have triggered a payment of 100 million dollars to Aelis Farma.
Unsurprisingly, Indivior issued a press release on Wednesday in which it indicated that it did not intend “at this stage” to exercise this option. This “given the absence of difference with the placebo with regard to the primary and secondary evaluation criteria, and before obtaining other favorable clinical data,” the company specifies.
Last month, Aelis Farma completed a capital increase of 4 million euros, which, coupled with cash of 20.2 million euros at the end of December 2023, should enable it to finance its activities until the fourth quarter of 2026.
By then, the company is expected to report results from a Phase 1/2 clinical study for its other key drug candidate, AEF0217, which aims to address cognitive disorders, including those associated with Down syndrome. These results are expected in the fourth quarter of 2024.
Julien Marion – ©2024 BFM Bourse
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