Aelis Farma: share collapses after clinical failure

(CercleFinance.com) - Aelis Farma sares fell over 40% in Paris on Wednesday, after the group announced disappointing results for its Phase 2b study on its drug candidate AEF0117, its treatment for cannabis abuse disorders.


After being booked lower at the opening, the biopharmaceutical company's shares fell by more than 42%, their lowest ever, in volumes representing more than 60 times their daily average over the last few days.

The brain disease specialist said the trial's primary and secondary endpoints had not been met with AEF0117.

The primary endpoint sought to determine the proportion of participants who reduced their cannabis consumption to no more than one day per week, while the secondary endpoints measured the proportion of participants achieving complete abstinence or reducing cannabis consumption to no more than two days.

On all these points, the trial showed no significant differences between AEF0117 and placebo, Aelis said in a statement.

This failure should be heavily punished by the market, warned analysts at Invest Securities this morning.

The teams at Oddo BHF also said they expected 'strong pressure' on the brain disease specialist's share price, leading them to review their 'outperform' recommendation and target of E25.

A new phase 2b trial with a larger population and possibly higher dosage will certainly have to be carried out before a phase 3 trial can be envisaged, it said.

In the meantime, the Anglo-American pharmaceutical company Indivior - which considers these results 'disappointing' - has stated its intention not to exercise its option on AEF0117 until it has seen further analyses of the clinical data.

Despite this setback, Aelis has indicated that it will continue to study the results of the study in order to determine the best strategic and regulatory course of action.

The group also has another drug project, AEF0217, for the treatment of cognitive disorders, including those associated with Down's syndrome (trisomy 21), for which the results of a phase 1/2 clinical study are expected in Q4 2024.


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