In this edition of "Rising High," The Fly conducted an exclusive interview with Jim Gilligan, Chief Scientific Officer and Interim Chief Executive Officer of Tryp Therapeutics (TRYPF), a clinical-stage biotech company focused on developing psilocybin-based compounds for diseases with unmet medical needs. Here are some highlights:
PSILOCYBIN-BASED TREATMENTS: Tryp Therapeutics aims to develop psilocybin-based treatments for chronic pain indications and eating disorders. The company has begun enrolling patients in a Phase II trial of TRP-8802, a non-proprietary 25 mg oral capsule of synthetic psilocybin, for the treatment of binge eating disorder at the University of Florida and announced in July 2021, an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP-8802 for fibromyalgia. The company is also working on TRP-8803, a proprietary psilocybin-based product using a novel formulation and route of administration to potentially improve efficacy, safety and the patient experience. “What attracted me to the clinical potential for psilocybin was that unlike traditional pharmacologic intervention, you start looking at what is the cause of the problem, not just treating the symptoms,” Gilligan said. “In chronic pain circumstances, you would administer an analgesic drug and to some extent maybe even opioids to address the pain, but you’re really not working out what is causing the pain. That ends up causing chronic treatment.”
The company is pursuing indications in fibromyalgia, phantom limb pain and complex regional pain syndrome. “The pain clearly originates in the brain,” he said. “We think that psilocybin has the potential to basically turn off that pain switch and provide relief to the patients.” Looking at overeating disorders, the company plans to focus on binge eating disorder and hypothalamic obesity. “Again we think that this is a behavior where there is a signal in the brain that’s causing overeating,” the Interim CEO said. “We want to be able to use the pharmacology of psilocybin in conjunction with psychotherapy to change that behavior and change that relationship between the patient and their eating behavior.”
He added Tryp is taking the approach of developing the product as an ethical pharmaceutical. “In order to do that, you need to have familiarity with regulatory authorities, in this case, the FDA,” Gilligan said. “We wanted to bring really sound science to our investigation and we think that helps with the credibility of moving psilocybin based therapies forward.” He cited the company’s ability to navigate the regulatory process as a key differentiator as well as its pursuit of two very distinct areas. “When we initiated the programs, there really weren’t any other groups pursuing those indications,” he said. “Then lastly, we also have our proprietary program, TRP-8803, which we think will afford a number of benefits to the patients.”
PHASE II BED TRIAL: In April, Tryp announced the dosing of the first patient in its Phase II clinical trial of TRP-8802 in combination with psychotherapy for the treatment of Binge Eating Disorder. “One of the issues with overeating disorders is there are very few, if any, current treatment paradigms that have been successful,” the interim CEO said. “If you look at patients who elected to have gastric bypass surgery, after about five years, they start to gain weight again. Why? Because the behavior that was causing the overeating hasn’t been addressed.” Tryp feels the key is to address the factors in the patient’s brain in conjunction with psychotherapy to change this behavior, he said. “One of the things that is interesting with psilocybin treatments across the spectrum is the drug is administered either once or twice, yet you see the durability of effect where the patients show benefits for three months and six months later,” he said. “Clearly the drug isn’t still present, but you really are changing some of the neural networks in the brain that are therefore contributing to this long-term benefit.”
PHASE 2A FIBROMYALGIA STUDY: In December, Tryp received confirmation from the FDA that it could proceed with its clinical study of TRP-8802 in combination with psychotherapy in fibromyalgia. The company expects to initiate the study in 2022. “One of the things that is difficult right now with performing psilocybin-based studies is not only do we need to go through the FDA, but you need to get DEA approval in order to administer the drug,” Gilligan said. “You need to do that both at the state level and the federal level.” Since the FDA approval, Tryp has been dealing with the DEA regulations and certain Michigan regulations to be able to administer the drug, he said. “It appears that the process could take as long as nine months,” the interim CEO said. “Our partners at the University of Michigan are outstanding and they are working through all of the bureaucracy.” He said he expects Tryp to initiate the study at the end of the summer or beginning of the fall.
TRP-8803: TRP-8803 is a proprietary, psilocybin-based drug, manufactured exclusively for Tryp by Curia featuring a novel route of administration expected to improve the patient experience. “What people are familiar with is a patient comes in the morning, and they’re administered an oral capsule of psilocybin,” the interim CEO said. “It can take anywhere from one to two hours before they enter the dissociative psychedelic state and that could last for six to eight hours.” That creates a potential burden for not only the patient, but also the therapist, he said, noting Tryp is looking to reduce that treatment time. “The other situation that we realize is that in the literature it turns out there is a large degree of variability when someone takes the capsule orally,” Gilligan said. “You can literally have some patients who do not enter the psychedelic state whereas others could have a bad trip. What we developed in 8803 is a novel formulation in administration where we can control the blood levels so that it’s very accurate.” The formulation allows Tryp to control when a patient goes into the psychedelic state as well as the duration of that experience, he said. “Then another important issue is an idiosyncratic response,” the Interim CEO said. “With 8803 if they are experiencing difficult side effects, we can terminate the administration and we can administer an anti-serotonin or a drug that would help them basically turn off the psychedelic experience.”
PARTNERSHIPS: Tryp has partnered with Curia to manufacture its Active Pharmaceutical Ingredient through a proprietary process giving the company control over its product supply for clinical trials as well as commercialization. “We’re taking the approach of an ethical pharmaceutical,” Gilligan said. “You need to have a very reproducible drug, have the dose be very precise, have certain purity standards and you also need to understand your audience.” He said Tryp’s audience is the FDA, and they’re accustomed to seeing drugs made through chemical synthesis. “Curia is a very well-respected contract manufacturer,” the interim CEO said. “We already advanced our manufacturing to work to commercial scale levels, up to multiple kilos, so that we’re prepared and having an exclusive license is great for us because they can’t make it for potential competitor.” The company has also formed a collaboration with Fluence for design and training for the psychotherapeutic portion of clinical trial activities. “The patients actually meet with those therapists for six to eight hours before they actually have what we call the intervention, before the dose is administered,” Gilligan said. “There aren’t that many psychotherapists that are trained in the administration of psychedelics and Fluence happens to have that expertise to train our therapists.” He said Fluence has also supported Tryp’s philosophy of working to customize therapies towards a specific indication. “The backbones of the therapy could be similar across indications, but the approach that we take with patients in overeating will be different and distinct from those with fibromyalgia,” he said. “They’ve been a great partner. They’re helping us at the University of Florida and we’re taking a similar approach to training at University of Michigan.”
SCHEDULE 1 DRUG: The Drug Enforcement Administration currently places psilocybin in Schedule I of the Controlled Substances Act, meaning the drug currently has no accepted medical use. “Given the fact that there’s a multitude of clinical studies going on, FDA-recognized and fast-tracked, it seems that we’re getting to the point where there is potential clinical benefit,” the Interim CEO said. “We hope that this will be recognized and that it will facilitate proper clinical studies to be performed.” He added well-respected institutes like Johns Hopkins, Yale, Imperial College of London, UC San Francisco and NYU are conducting sound clinical research, which affords credibility to the field. “Hopefully this will help the removal of psilocybin from the Schedule I listing and make it easier for people to perform the requisite clinical research to demonstrate the clinical utility of the molecule,” Gilligan said. “Right now, it is a barrier.”
CHALLENGES: When asked about the largest hurdles facing the psychedelic space, Gilligan pointed to perception as one possible challenge. “Certain people due to the cultural history are skeptical,” Gilligan said, noting he has been in the medical research field for over 35 years and was doubtful of the potential benefits of psychedelics. “It wasn’t until I started reading the scientific literature that I realized I was wrong, that there was a sound, scientific basis for the clinical utility and benefit,” he said. “More good, quality research done at reputable institutions is going to be the best way to get people to start looking at the fact that there appears to be a tremendous level of potential across many different areas.” The interim CEO added that neural networks control many, many different functions and having the ability to rearrange them could have a benefit in numerous distinct indications. “We are trying to demystify the mystical experience,” he said. “We’re trying to understand it so that we can optimize how we approach patients for benefit. The better we understand it, the better we can communicate that to people at large and there will be better acceptance.” The interim CEO said showing a clinical benefit will be the best solution to get people to start believing in the potential.
OPPORTUNITIES: As the psychedelic industry develops and matures, the interim CEO said Tryp is most excited about the opportunity to help patients. “For us right now, even though it’s early stages, we’re getting positive reinforcement from patients’ experiences,” he said. “If we can help people live more productive, better, happier lives, that is the goal.” Gilligan said the sooner that Tryp can get into a clinic and demonstrate benefit, the sooner the company is going to be able to help people with tremendous unmet medical needs. “For fibromyalgia after a year, only about 10% of patients see a benefit and unfortunately a third of them will resort to use of opioid analgesics,” he said. “If we can help even a fraction of those people alleviate their pain and resume a normal pain-free life, to me that’s the most exciting aspect. That’s what gets me ready to go to work every day and move these programs forward.”
OTHER CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Awakn Life Sciences (AWKNF), Audacious (AUSAF), Aurora Cannabis (ACB), Ayr Wellness (AYRWF), BC Craft (CRFTF), Body and Mind (BMMJ), CanaFarma (CNFHF), Cannara Biotech (LOVFF), Canopy Growth (CGC), RIV Capital (CNPOF), Chicago Atlantic (REFI), Columbia Care (CCHWF), Compass Pathways (CMPS), CordovaCann (LVRLF), Clever Leaves (CLVR), Cresco Labs (CRLBF), Cronos Group (CRON), CV Sciences (CVSI), Curaleaf (CURLF), CURE Pharmaceutical (CURR), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), FluroTech (FLURF), General Cannabis (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Harborside (HBORF), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), Innovative Industrial Properties (IIPR), IM Cannabis (IMCC), India Globalization Capital (IGC), Indiva (NDVAF), InterCure (INCR), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm (MEDIF), MedMen (MMNFF), MJardin Group (MJARF), Neptune Wellness (NEPT), NewLake Capital (NLCP), Thermic Science (ENDO), Organigram (OGI), Planet 13 (PLNHF), Relmada (RLMD), RYAH Group (RYAHF), Sproutly (SRUTF), Stem Holdings (STMH), Small Pharma (DMTTF), Skye Biosciences (SKYE), Sundial Growers (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Valens (VLNCF), Verano Holdings (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).
Goodness Growth
-0.05 (-3.40%)
ZYNE
+
Trulieve Cannabis
-0.135 (-0.93%)
Tilray
+0.15 (+3.13%)
IGC Pharma
+
Green Thumb Industries
-0.52 (-4.27%)
Trees Corporation
+
Cronos Group
+0.155 (+4.66%)
Canopy Growth
+0.3 (+5.37%)
CannTrust
+
CV Sciences
+
Aurora Cannabis
+0.175 (+6.02%)
Relmada Therapeutics
-0.3 (-1.39%)
Compass Pathways
+0.36 (+4.37%)
Atai Life Sciences
+0.125 (+3.17%)
Tryp Therapeutics
+