MindMed Update MindMed Concludes Phase 1 dosing of 18-MC: “Mind Medicine… has concluded dosing in a Phase 1 Single Ascending Dose (SAD) study of 18-MC. The dosing of 18-MC was well tolerated in humans and will help advance planning for a Phase 2a clinical trial in opioid addiction… The study tested doses ranging from 4mg to 16mg twice a day and all participants were evaluated for pharmacokinetics and safety… MindMed plans to begin the Phase 2a study of 18-MC in opioid addiction by the end of this year.”
On the topic of trials in participants with substance use disorders, it would not be surprising for MindMed to hire a CRO with experience in these populations to run the trial. In that case, MindMed would learn very little. No matter what they do, their knowledge will be small compared to groups that have worked on this area for years. So this isn't esoteric knowledge that only MindMed would have. NIDA puts significant money into treatment trials and maintaining this expertise. Much of the success in recruitment depends on small details like reducing time between contact with participants (eg, if someone contacts you expressing interest, bring them in the next day or two, not the next month), helping with transportation once they're in the study, and having a thoughtful approach to reimbursement. Finally, you're plausibly optimizing on cost per completed participant not on dropout rate. If someone is high risk of dropping out, you want it to happen as early and inexpensively as possible.
The motivations for applying for a patent on psilocybin synthesis presumably include protecting your ability to manufacture, specifically having legal ammo for litigation against other manufacturers. That is, it help you to be able to countersue if you're sued. Also, patent applications (no matter how improbable) make you seem valuable to investors, which young companies desperately need to do. I don't know MindSet's strategy, but it sounds like they are saying they want to supply active pharmaceutical ingredients for investigator-initiated clinical trials as an early income stream. This manufacturing capability could then position them to release a generic psilocybin medicine in 8 or 9 years or whenever exclusivity expires for any FDA-approved products. And they'll be positioned for supplying material for consumer products if/when/where that becomes legal.
In regards to some of your musings re Mindset Pharma and others looking to create revenue streams from production of non patentable compounds - From my understanding the potential goldmine is in finding the cheapest way to produce something like psilocybin. In the rub lies in the fact some methods may be exponentially cheaper. Examples that spring to mind would be Octarine Bio and CB Therapeutics. Both are looking to develop proprietary biosynthesis methods using genetically modified microorganisms like yeast. If successful batch fermentation of GM yeast could produce a far higher yield at a far lower cost than methods using direct organic chemistry synthesis or distillation from mycological sources, essentially blowing their competitors out of the water with their ability to provide low cost compound. The IP would then lie in the creation of a specific GMO used in the biosynthesis method and/or the enzymes involved. These novel biosynthesis processes could also then be potentially piggyback production of other novel (read patentable) psychedelics as a future source of growth for which ever company has the IP.
Not sure if this what you were wondering about but hope it's helpful!
Cheers,
Finnebar
(My views are informed by a Medical Degree with a previous BSc in Molecular Biology & Statistics).
On the topic of trials in participants with substance use disorders, it would not be surprising for MindMed to hire a CRO with experience in these populations to run the trial. In that case, MindMed would learn very little. No matter what they do, their knowledge will be small compared to groups that have worked on this area for years. So this isn't esoteric knowledge that only MindMed would have. NIDA puts significant money into treatment trials and maintaining this expertise. Much of the success in recruitment depends on small details like reducing time between contact with participants (eg, if someone contacts you expressing interest, bring them in the next day or two, not the next month), helping with transportation once they're in the study, and having a thoughtful approach to reimbursement. Finally, you're plausibly optimizing on cost per completed participant not on dropout rate. If someone is high risk of dropping out, you want it to happen as early and inexpensively as possible.
The motivations for applying for a patent on psilocybin synthesis presumably include protecting your ability to manufacture, specifically having legal ammo for litigation against other manufacturers. That is, it help you to be able to countersue if you're sued. Also, patent applications (no matter how improbable) make you seem valuable to investors, which young companies desperately need to do. I don't know MindSet's strategy, but it sounds like they are saying they want to supply active pharmaceutical ingredients for investigator-initiated clinical trials as an early income stream. This manufacturing capability could then position them to release a generic psilocybin medicine in 8 or 9 years or whenever exclusivity expires for any FDA-approved products. And they'll be positioned for supplying material for consumer products if/when/where that becomes legal.
Hi Zach,
In regards to some of your musings re Mindset Pharma and others looking to create revenue streams from production of non patentable compounds - From my understanding the potential goldmine is in finding the cheapest way to produce something like psilocybin. In the rub lies in the fact some methods may be exponentially cheaper. Examples that spring to mind would be Octarine Bio and CB Therapeutics. Both are looking to develop proprietary biosynthesis methods using genetically modified microorganisms like yeast. If successful batch fermentation of GM yeast could produce a far higher yield at a far lower cost than methods using direct organic chemistry synthesis or distillation from mycological sources, essentially blowing their competitors out of the water with their ability to provide low cost compound. The IP would then lie in the creation of a specific GMO used in the biosynthesis method and/or the enzymes involved. These novel biosynthesis processes could also then be potentially piggyback production of other novel (read patentable) psychedelics as a future source of growth for which ever company has the IP.
Not sure if this what you were wondering about but hope it's helpful!
Cheers,
Finnebar
(My views are informed by a Medical Degree with a previous BSc in Molecular Biology & Statistics).