In this edition of "Rising High," The Fly conducted an exclusive interview with Greg Mayes, Chief Executive Officer, and Nathan Bryson, Chief Scientific Officer, of Reunion Neuroscience (REUN), a novel psychedelic drug development company. Here are some highlights:
CEO APPOINTMENT: Reunion is company committed to innovating therapeutic solutions for mental health conditions by developing proprietary serotonin receptor agonist compounds. The company’s lead asset, RE-104 is a proprietary psychedelic drug being developed for post-partum and treatment resistant depression as a potential fast-acting antidepressant. In September, Reunion appointed Greg Mayes, former president and CEO of Antios Therapeutics, as President and CEO. “I am absolutely thrilled to be at Reunion Neuroscience,” he said. “The opportunity for me to take my biotech career, use all those tools I’ve developed over the past 20 years and apply them to a new and novel technology like Reunion Neuroscience has and move it forward as a new and innovative way to treat depression and anxiety is an opportunity I could simply not pass on.” The CEO noted mental health is a personal passion area for him, giving him extra drive for success. Mayes founded Engage Therapeutics in 2017, inspired by his son’s epilepsy diagnosis, he said, and the company was acquired by UCB Pharma for $270M in 2020, following data from a Phase 2b clinical trial evaluating its Rapid Epileptic Seizure Termination treatment. “I think that the number one co-morbidity associated with epilepsy is depression and anxiety and there’s too much emphasis placed on future management,” he said. “Much more attention should be drawn to anxiety and depression. The opportunity presented by psychedelics to dramatically bend the curve in terms of people suffering with those illnesses is amazing”.
When asked about his growth strategy for Reunion, Mayes pointed to three pillars needed to move forward in a strategic manner. “The first thing is we’re going to have Phase I data presented most likely early next year,” he said. “I believe that data will show that we have an active compound that can be safely administered. That will put us on the map and pathway to a regulatory filing with the FDA and most importantly, the opening of a robust Phase 2 program in the second half of 2023 that will focus on post-partum depression.” He said Reunion chose PPD because it is episodic, there’s a huge unmet medical need and the company should be able to rapidly enroll and complete the study within eighteen months.
COMPETITIVE EDGE: As competition increases in the psychedelics space, Mayes pointed to Reunion’s intellectual property protection as a key differentiator. “We have composition of matter patents on RE-104, with protection out through 2040,” he said. “When you look at other psychedelic companies, of which there are many that are in pre-clinical or clinical development, they do not afford that level of protection.” The IP will be an important element of being able to finance clinical programs for RE-104 going forward, the CEO said. “Another differentiating factor is that, based upon the chemical structure of RE-104, we have the prospect to have a shorter psychedelic experience,” he said. “That would allow for greater patient acceptability and interest as well as lower burden to the healthcare system.” Reunion also has the only psychedelic molecule going into Phase 2 development for PPD in 2023, Mayes said. “It is important to recognize that within the psychedelic space, there are attributes that RE-104 has that others do not,” he said. “We want to continue to showcase and highlight them as our clinical development program reads out its Phase 1 data in early 2023 and we commence our Phase 2 program later in 2023."
RE-104: RE-104, a proprietary psychedelic drug, is Reunion’s lead asset being developed for post-partum and treatment resistant depression. “We did take the time to go back and look across a broad spectrum of potential indications for drugs of this nature,” CSO Nathan Bryson said. “We wanted to keep at least our initial developments low-risk where there was an abundant amount of evidence to support the development that we were going to do. That’s why we chose initially to start out in depression.” He added depression will not be the only space Reunion focuses on, but it is an area where the company wanted to start. “There is a great need and a lot of potential for the drug to make inroads in the space because there hasn’t really been much development in the last 30 years,” the CSO said. “Treatment-resistant depression has the biggest support for evidence and that was part of the rationale for choosing that. PPD was a bit new for most people to be looking at and we chose it in part due to the unique characteristics of RE-104 being a very short-acting drug.” Following a short psychedelic experience, mothers can be back to their babies in a half a day, he said. “If the data rings true from our preclinical, the washout can be quite rapid and we can have mothers back to breastfeeding within 24 to 48 hours,” Bryson said. “That would be a great benefit relative to any of the other products available to them now.” The indication also allows for a very fast development pathway as it’s an episodi- type depression, he said. “It doesn't require long-term safety studies to the same extent as other indications, where you might have to give the drug repeatedly over the lifetime of a patient,” the CSO said. “Your endpoints are shorter, your studies are smaller and you can achieve a demonstration of safety and efficacy much faster overall. It becomes a more cost-efficient development pathway to the market in a space that is less competitive and where we can actually make our mark in this niche.”
RE-104 is in a Phase I single-dose escalation study with subjects experienced in the use of psychedelics that is currently ongoing in Australia. “We chose experienced users because they can explain the psychedelic nature of the drug a little bit better,” Bryson said. “It will be a truer readout on the psychedelic experience itself.” Reunion has been through a couple of cohorts in the study, he said, and expects a readout early next year. “We are progressing through the cohorts, which indicates that we’re seeing good signs of safety,” the CSO said. “The safety review committee is accepting that we can move and progress through the doses that we planned in our protocol.” The primary focus of the study is to look at the pharmacokinetics and the safety of drug and Reunion will also be capturing both the duration of the experience and intensity as measured by validated questionnaires, he said.
RE-200 SERIES: Reunion is also developing the FT-200 series, which includes compounds with potential for more selective serotonin receptor activity with reduced psychoactivity for potential use in more chronic treatment paradigms and indications. “RE-104 and a lot of potential psychedelics have tremendous benefits and they have been able to be shown, but I think there can be improvements like there has been with any other drug out on the market,” the CSO said. “We want to continue to improve on the safety and efficacy of these drugs.” He noted there are aspects of cardiovascular activity that can be seen in classical psychedelic use and the company would like to improve on those aspects by enhancing selectivity to stay away from receptor systems. “In particular the 5-HT2B system, which can lead to valve hardening when there is extended exposure to the drug,” Bryson said. “What it will allow us to do is to expand into a broader set of populations of patients who may have a weakness in the cardiovascular system and may be excluded from the use of psychedelic drugs.” Reunion has filed provisional patents on a couple of families of the molecules and over time will be able to select from the families the most potent and the safest molecules, he said. “One of the particular aspects we are starting to see is as the potency goes up, some of the molecules turn out to be less psychedelic,” the CSO said. “It may be possible that we can get to a molecule that is a 2a agonist, provokes the antidepressant effect and neuroplasticity that we see with psychedelics, but doesn’t have the psychoactivity.”
DRUG SCHEDULING: Several psychedelics like psilocybin and MDMA are listed as Schedule I drugs under the Controlled Substances Act in the U.S. and Bryson said he views drug scheduling as an essential protection for patients. “We currently enjoy the fact that RE-104 is not a scheduled substance, so it doesn’t inhibit it us yet in our development program,” he said. “If it does become scheduled, it will most likely become Schedule I to protect society and protect ourselves as we finish the development.” Once development is finished, Reunion will work with the DEA to find the appropriate scheduling for the drug, the CSO said. “Most likely we’ll see something like a Schedule II or a Schedule III, for in clinic or in hospital use,” he said. “I don’t see scheduling as a major issue. It is a natural regulatory event that we work through and we will do the right things to make sure that we protect everyone as we go forward with RE-104.” Mayes added the DEA has suggested it will reduce a molecule or psychedelic scheduling one level if it precedes to get approval from the FDA. “It gives a very strong rationale to sponsor firms such as Reunion Neuroscience to proceed ethically through the full and complete FDA review process, which will determine whether the product is safe and effective,” he said. “We’re very excited with how the regulatory landscape is shaping up for the psychedelic sector.”
CHALLENGES: When asked about the largest hurdles facing the psychedelics industry, the CSO noted he sees a couple of challenges on the technical side from an industry standards standpoint. “Understanding how to run clinical trials in psychedelics that can be properly blinded is a challenge,” he said. “There is a lot of rigor in how to run a proper trial and maintain as much blindness as possible, when a patient is susceptible to guess which study group they’re in.” Bryson pointed to another issue around uncertainty of how to apply psychotherapy and how much an individual needs to get the best outcomes. “That is while trying to keep it as light as possible in some sense, so that it can be accessible to a variety of doctors who want to administer it,” he said. Mayes added that the CDC reported in September that 25% of young adults in America are in mental health treatment programs. “That does not include those that are undiagnosed or those that are refusing treatment,” he said. “This is an epidemic proportion of people that continues to rise each day. The big challenge for psychedelics continues to be how are we able to move forward with a bolus of data that can convince regulatory agencies as well as people that suffer from mental health illness to take a psychedelic.” The CEO said there is still a very significant portion of people rolling their eyes at the ability for psychedelics to be a meaningful treatment option. “I do believe that over time with data from Reunion Neuroscience and other psychedelic therapeutic developers that hopefully this mindset will change,” he said. “The challenges present our greatest opportunity.”
OPPORTUNITIES: As the psychedelic sector develops, Mayes said he sees the biggest opportunity in the development of RE-104. “We have a wonderful molecule that I think we are being very selective and thoughtful about entering into the post-partum depression space,” he said. “I think we can be successful here.” The CEO cited a recent report by the CDC, which said 80% of women who die within the first year of motherhood have their cause of death attributed to mental health. “We are going to prove in a highly episodic illness that we could be safe and effective for women with post-partum depression,” he said. “It’s a meaningful opportunity for us, but the bigger opportunity over time will be the large body of other potential indications where we can see the benefits of psychedelics.” Mayes noted addiction, post-traumatic stress disorder and other illnesses that are yet to be explored, adding the opportunities are countless. “We have to be smart,” he said. “If we take too much on as a small biotech with limited cash resources, we won’t get there. I’m really happy with the path that Reunion Neuroscience has set out, which is get to meaningful Phase I data and then move right into an area of high unmet medical need that can help women who have recently undergone childbirth.” Mayes added that he would characterize the benefit of psychedelics in a broad-brush way as offering hope for patients with depression. Bryson agreed providing hope to individuals who have been unable to find relief for their symptoms is a huge opportunity. “We want to bring hope in a broad set of indications and if we do that, we’ve done a good job,” he said.
CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Audacious (AUSAF), Aurora Cannabis (ACB), Awakn Life Sciences (AWKNF), Ayr Wellness (AYRWF), Body and Mind (BMMJ), Canopy Growth (CGC), Cannara Biotech (LOVFF), Chicago Atlantic (REFI), Clever Leaves (CLVR), Columbia Care (CCHWF), Compass Pathways (CMPS), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos (CRON), Curaleaf (CURLF), CURE Pharmaceutical (CURR), CV Sciences (CVSI), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen (MMNFF), Neptune Wellness (NEPT), NewLake Capital (NLCP), Thermic Science (ENDO), Organigram (OGI), Planet 13 (PLNHF), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Sproutly (SRUTF), Stem Holdings (STMH), Small Pharma (DMTTF), Skye Biosciences (SKYE), SNDL (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), The Valens Company (VLNS), Verano Holdings (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).
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