BORDEAUX, France–(BUSINESS WIRE)–AELIS FARMA (“AELIS”), a biotechnology company specializing in the treatment of brain disorders, today announced a strategic collaboration and option-license agreement with INDIVIOR PLC (LON: INDV) to address the serious consequences of cannabis use disorders (CUD), including cannabis-induced psychosis (CIP).
Dr. Pier Vincenzo Piazza, Co-founder and Chief Executive Officer of AELIS, said: “We are very excited to collaborate with INDIVIOR, whose experience developing approved treatments for addiction and serious mental illnesses will accelerate the development of our new class of therapeutics and the unique approach to cannabis use disorders they provide. This strategic collaboration will enable us to help more patients suffering from cannabis-induced pathologies, which is a large and widely underserved global market. CIP has been identified as the first cause of emergency room (ER) entries for acute psychosis in Europe and, in the U.S., more than 500,000 ER entries per year are due to cannabis use. Further, there are more than 8 million individuals with a diagnosis of CUD in Europe and in the U.S. Because of widespread legalisation of recreational cannabis use, these figures are expected to grow in the upcoming years.”
AELIS’s AEF0117 is the first drug candidate of a new pharmacological class, the Signaling Specific Inhibitors of the CB1 receptor (CB1-SSi), that AELIS developed over the last seven years. AELIS has built extensive knowledge and intellectual property rights around this new family of inhibitors of the CB1 receptors. Thanks to a unique mechanism of action, CB1-SSi selectively inhibit a CB1-mediated hyperactive state, thus preserving the normal functioning of the brain and behaviour.
Under the terms of the agreement with AELIS, INDIVIOR PLC is being granted an option to an exclusive worldwide license for AEF0117 for the treatment of cannabis-related disorders, and in particular, addiction and psychosis. The collaboration will be coordinated by a joint steering committee comprised of drug development leadership from AELIS and INDIVIOR. During the option period AELIS will conduct clinical and non-clinical development to ready AEF0117 to enter Phase 3. If INDIVIOR exercises the option, it would then be responsible for all future development, regulatory, commercial and manufacturing costs and activities.
AELIS will receive an immediate upfront payment of $30 million. Upon successful phase 2b proof of concept studies for cannabis use disorders, INDIVIOR could exercise the option triggering a $100 million license fee payment. AELIS is also eligible to receive additional payments for achieving certain further development and regulatory milestones, as well as mid-teens royalties on any net sales. The phase 2b that will be executed during the option period is a multi-center study evaluating the efficacy of AEF0117 as a treatment of CUD, which will be coordinated by Prof. Frances Levin at Columbia University in the U.S.
AELIS is now broadening its pipeline with a second compound (AEF0217) at the clinical stage, developed as a treatment for cognitive disorders, and several new compounds generated on its proprietary CB1-targeted drug screening platform.
“The collaboration with AELIS is a great opportunity for INDIVIOR. The new pharmacological class developed by the company furthers INDIVIOR’s strategy of targeting innovative treatments for substance use disorders where there is a growing unmet public health need. We look forward to partnering with the AELIS team on AEF0117 in a joint goal to bring the first medication for the treatment of cannabis use disorders to market,” said Mark Crossley, INDIVIOR’s Chief Executive Officer.
“We look forward to working with the team at INDIVIOR to bring new treatment options to patients with cannabis-related disorders. We expect that the joint efforts prompted by this agreement will enable INDIVIOR to leverage AELIS’s extensive knowledge of Signaling Specific inhibitors of the CB1 receptor (CB1-SSi), and further accelerate the development of treatment options for a broader range of substance use disorders,” noted Dr. Piazza.
About AELIS FARMA
AELIS FARMA is a clinical-stage biotechnology company founded in 2014 as a spin-off of the Magendie Neurocenter in Bordeaux, a leading Neuroscience institute of INSERM (French National Institute of Health and Medical Research) and University of Bordeaux. AELIS FARMA’s mission is to develop a new pharmacological drug class, the Signaling Specific inhibitors of the CB1 receptor (CB1-SSI) that were discovered by the research team of Dr. Pier Vincenzo Piazza, the Company’s CEO, during his tenure as director of the Magendie Institute. For this discovery Dr. Piazza was awarded the Grand Prix of INSERM and the Grand Prix of Neurology of the French Academy of Science that are among the most prestigious French scientific awards.
CB1-SSi have potential application for the treatment of numerous disorders. The Company is currently developing two first-in-class drug candidates: AEF0117, and AEF0217.
AEF0117, which targets cannabis related disorders (CUD and psychosis), has been studied in a Phase IIa trial in subjects with cannabis use disorders and was performed at Columbia University (NY, USA) and shown positive signs of efficacy; it will now enter into a Phase IIb trial.
AEF0217, which is being developed for the treatment of cognitive impairments, will enter Phase I clinical trials in the second half of 2021 and will be first tested as a therapy of cognitive deficits in Down syndrome.
AELIS FARMA also has a CB1-targeted Platform that has already generated novel leads with differentiated pharmacological characteristics.
AELIS FARMA has its headquarter at the Magendie Neurocenter in Bordeaux and has received grants and/or investments from the Nouvelle-Aquitaine region, the European Union, NIDA (National Institute on Drug Abuse, NIH, USA), Inserm Transfert Initiative, Bpifrance, Aquiti, NACO and Irdi Capital Investissement.