Dr. James Gilligan | President and Chief Scientific Officer, Tryp Therapeutics

Dr. Gilligan has over 35 years of experience in the life sciences industry, including R&D, clinical development, international regulatory affairs, and manufacturing. Prior to joining Tryp Therapeutics, Dr. Gilligan was a Co-Founder and Managing Partner of The Bracken Group, a life sciences consulting firm providing regulatory and product development support to pharmaceutical and biotech companies. Dr. Gilligan was a co-founder of Unigene Laboratories, which develops technology for the recombinant manufacture of peptide hormones, as well as oral and nasal delivery technologies for peptide based therapeutics. Dr. Gilligan was also a Co-Founder and the Chief Scientific Officer of Tarsa Therapeutics.

Dr. Gilligan received a PhD from University of Connecticut and a Masters in International Business from Seton Hall University. He continued his post-graduate education at the Roche Institute of Molecular Biology.
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TRYP has, arguably, the most drug development experience in the industry. Can you tell us why that is an advantage for TRYP and how that’s helping position you guys as leaders in the space? 

Drug development is a complicated business which requires a wide spectrum of expertise to be successful. As in many instances the Drug development Team is only as good or as strong as its weakest link.  To not only be successful but to complete projects on time and on budget you need the individual areas of expertise to be integrated and supportive.  Clinical research always has high visibility but for instance without the requisite CMC expertise to make the active ingredient and the final product the Clinical trial cannot initiate.  The same can be said for Regulatory Affairs expertise; needed for interaction with FDA and filing of all regulatory documentation prior to starting your clinical trials. 

TRYP has assembled a world class team that have been successful many times over and that meet all of the diverse requirements for building a successful drug development company.  The TRYP Team is built for success, as I have stated on several occasions, it is management’s job to reduce risk to the lowest possible levels to provide for the highest possible level of achieving success.  That is exactly what we are doing, and are excited to bring our experience to the psychedelic sector. 

You have over three decades of experience in life sciences and clinical development. What first got you excited about psychedelics and their therapeutic potential?

What I have learned during my 30+ years in drug development is to try to remove as much risk as possible during the drug development process.  The ability to move a product into clinical studies to demonstrate proof of concept is also a key goal.  When working with new chemical entities (NCE) the road to human studies is long and tortuous with many potential pitfalls. 

TRYPs lead program with psilocybin focuses on a known molecule with significant history enabling a rapid move into clinical testing.  The same can be said about razoxane being developed for the treatment of soft tissue sarcomas, TRYP is able to leverage historical data to move to the clinic to confirm Razoxane’s therapeutic potential in treating this cancer for which there are currently limited options.

Tryp is focused on developing orally delivered drug therapies for certain neuropsychiatric disorders that have advantages over other drugs available. Can you share what you see some of these advantages being and how that will help patients?

There are many chronic diseases such as fibromyalgia where the current therapies are unsatisfactory.  In many instances current therapies treat the symptoms not the disease itself.  Often the etiologic factor responsible for causing the disease and hence symptoms are not the target of the drugs being used.  An example would be if an individual has a fever due to a bacterial  infection and the only drug used was aspirin to lower the individual’s temperature you would not be treating the cause of the fever but rather the symptom of the infection.

With psilocybin intervention we are hoping to address the cause of the chronic pain for patients with fibromyalgia and not offering another analgesic which will need to be administered chronically.  We are hoping for instance to be able to reduce the use of harmful and addictive opioids in this patient population. 

What made the team at Tryp decide to focus on fibromyalgia as your lead indication for TRP-8802?

There is information in the literature that suggests psilocybin in conjunction with psychotherapy may be effective in patients with chronic disease.  Fibromyalgia pain appears to emanate from the CNS (Central Nervous System) and therefore represents a good target for psilocybin therapy.  As mentioned previously the current drugs used in fibromyalgia suffer from lack of efficacy or associated with numerous side effects which result in a lack in patient compliance. 

From your perspective, why has there not been a major breakthrough in treatment around fibromyalgia yet and what gives you a strong belief TRP-8802 could be a major leap forward?

To date, the therapeutic approach to fibromyalgia has been to treat it with drugs that target neuropathic pain or use potent analgesics including opioids to only help the symptoms.  Given that patients with fibromyalgia do not have pain associated with issues like chronic inflammation  in osteoarthritis or associated with measurable local pathologic changes, a new approach is desperately needed.  Current research at leading universities suggest that for patients with “phantom limb pain” for example where the patient perceives pain in an extremity that is no longer present psychedelic drugs targeting the CNS may prove beneficial.  Fibromyalgia pain also originates in the CNS and therefore represents an attractive target for the use of psilocybin in conjunction with psychotherapy.

We understand that TRYP is focusing on utilizing the “502(b) pathway” as part of their strategy to expedite clinical development. You have a long history in that area, can you help explain what that process is for our readers, and why it’s important?

The 505(b)(2) NDA pathway allows a company to leverage information from the literature or from prior approvals to accelerate a company’s program development.  For example, a traditional 505(b)(2) approach is changing the route of administration for a drug already FDA approved, or when seeking a new indication for an approved drug.  This avoids the need to repeat the toxicology studies the manufacturing sections may already be in place greatly reducing the NDA burden. In the case of TRYP, we will be able to leverage the wealth of information available for both psilocybin and razoxane to support our regulatory filings, save considerable time and money, and expedite our clinical trials.

Where do you see psychedelic medicines in the future and how much of an impact do you think they will make on healthcare as a whole? 

As science and medical research progress we gain increasing insight into the genesis of certain disorders.  In parallel we have a better understanding of brain function, neuroplasticity and the role psychedelic drugs can have in impacting, in a positive way, neuroplasticity.  By integrating the use of psychedelics into a whole patient treatment paradigm and creating an environment that includes psychiatric professionals working intimately with the patients before, during, and after drug administration, we are witnessing the emergence of a new treatment paradigm with significant potential.