MindMed (NASDAQ: MNMD, NEO: MMED, DE: MMQ), a leading clinical stage psychedelic medicine company, and Nextage Therapeutics (TASE: NXTG), an Israeli innovative drug development company, announce the execution of a Memorandum of Understanding (the “MOU”) regarding the launch of an exclusive collaborative development program to optimize the delivery of certain psychedelic drug candidates, leveraging Nextage’s proprietary Brain Targeting Liposome System (BTLS) delivery technology, for which it has an exclusive license. MindMed and Nextage will initially collaborate to optimize the delivery of drug products based on noribogaine, and ultimately other ibogaine derivatives, and will share development costs and intellectual property arising from the collaboration.
The BTLS technology is an innovative drug delivery system designed to allow the targeted delivery of active pharmaceutical ingredients (APIs) through the Blood Brain Barrier. BTLS is designed to reduce exposure to the active material outside of the brain, reducing potential risks, intended to substantially lower API concentrations and increasing efficacy.
Using this state-of-the-art drug delivery technology, MindMed is seeking to capitalize on the opportunity to mitigate the serious side effects that can make some orally administered psychedelics poor drug candidates. There is anecdotal evidence which suggests the psychedelic substance ibogaine can be effective in the treatment of opioid addiction, but orally administered ibogaine and noribogaine present unacceptable safety risks due to their torsadogenic effects at high systemic concentrations.
Utilizing Nextage’s proprietary brain-targeted liposome system, the collaboration will seek to develop a proprietary formulation aimed at minimizing the systemic exposure of ibogaine derivatives while maintaining effective concentrations in the brain, with the objective of significantly improving the risk-benefit profile of their delivery.
Nextage CEO, Mr. Abraham Dreazen, said “Our innovative delivery technology has potential to revolutionize brain and CNS treatment. Psychedelic inspired drugs could be a breakthrough in many brain-related disorders and working together with an industry pioneer such as MindMed may open the door for life-changing treatments for patients globally. Nextage is pioneering these emerging technologies in Israel and we look forward to working with MindMed and forming a long and successful collaboration.”
Based on initial Proof of Concept work, MindMed and Nextage will work towards a final collaborative development agreement and a determination if such potential formulations of drug candidates should be further progressed into clinical trials.
Pursuant to the MOU, the parties will jointly pilot the development of a drug product based on noribogaine (the “Pilot Program”) with the parties sharing the development costs equally. At the same time that they are advancing the Pilot Program, MindMed and Nextage will negotiate a definitive written agreement to facilitate long-term collaboration on the development and commercialization of any contemplated conjugation of agreed pharmaceutical ingredients with BTLS. Nextage also granted to MindMed an exclusive, non-transferable, sublicensable license to all intellectual property, and the use of all new data, study results, know-how, arising from the Pilot Program in order to make submissions to those regulators whose approval is required in order to market a product.
MindMed and Nextage shall each retain all rights to any intellectual property and inventions owned by them prior to the commencement of the Pilot Program, and to any of their rights unrelated to the Pilot Program. MindMed and Nextage shall jointly own all new data, study results, and know-how developed from the Pilot Program. If the two companies fail to agree on the further development or application of any jointly owned know-how, whether patentable or not, within 12 months of initiating the Pilot Program, then each shall be entitled, subject to some conditions, to pursue independently the further development and commercialization of such know-how.
MindMed Executive President Dr. Miri Halperin Wernli said “Our collaboration with Nextage builds on the commitment of both companies to discover new ways by which we can shake adaptive mechanisms which normally constrain our perception, emotions and self-references. By joining forces and applying Nextage’s innovative BTLS technology which allows for a targeted delivery of substances through the Blood Brain Barrier we aim to find better ways to ultimately free the brain to experience new and unusual patterns of connectivity.”