Developing the next wave of psychedelic treatments.

Tryp Therapeutics is pursuing Phase 2 clinical trials using its psilocybin-based drug products for chronic pain and other indications.

Tryp’s pipeline differs from other psychedelic drug development companies in three important ways.

1. Unique Indications

The first wave of psychedelic drug development has been focused on mental health disorders such as depression, anxiety, addiction and PTSD.

As the leader in next-wave development, Tryp is evaluating psilocybin-based drug products for chronic pain and other indications with multiple Phase 2a trials initiating in 2021.

Tryp is one of just a handful of psychedelic drug development companies that will be conducting Phase 2 clinical trials in 2021.

2. A proprietary formulation and delivery method.

Our psilocybin-based drug product, TRP-8803, features a proprietary formulation and novel method of administration to improve the patient experience. We have filed a provisional patent to protect the unique features of TRP-8803.

3. An exclusive supply chain.

We’ve secured an exclusive supply of our psilocybin-based active ingredients and drug products, with sufficient quantities of material to support clinical trials and ultimate commercialization—a rare capability among psychedelic drug development companies.

• Our Active Pharmaceutical Ingredient (API) and final drug products are manufactured in the U.S., circumventing clinical trial import restrictions.
• Our vertical integration will allow us to supply the international research community with synthetic psilocybin.
• Tryp employs current good manufacturing processes (cGMP) to meet the requirements of FDA-approved drugs. 

As part of our Psilocybin For Neuropsychiatric Disorders (PFNTM) program, we’re currently testing two drugs for efficacy and patient experience: TRP-8802 and TRP-8803.

Our novel method of administration for TRP-8803 is expected to improve the patient experience. Our drug products are given in tandem with psychotherapy before and after drug treatment.

TRP-8802

This non-proprietary 25 mg oral capsule of synthetic psilocybin will be used to determine initial efficacy of the drug product for our indications.

As Tryp Therapeutics is solely focused on psilocybin, and because more than 50 FDA-registered studies have firmly established the compound’s safety profile, we expect to bypass preclinical and Phase 1 studies and enter directly into Phase 2a clinical trials.

TRP-8803

This proprietary, psilocybin-based drug is manufactured exclusively for Tryp by Curia and Alcami and features a novel route of administration.

Bridging studies are being completed with the University of Michigan and other institutions to prepare TRP-8803 for use in Phase 2b clinical trials and beyond.

We expect the proprietary formulation of TRP-8803 and its unique route of administration to improve the patient experience.

The need is clear. So is the solution.

A closer look at patient needs:

Fibromyalgia

• Existing treatments have limited efficacy and significant side effects for the 4 million individuals in the US who have been diagnosed with fibromyalgia.
• Fewer than 10% of patients adhere to approved treatments after one year.
• Nearly 30% of patients take opioids despite the lack of evidence for efficacy and the risk of addiction and/or overdose.

 Phantom Limb Pain

• More than 1 million people have been diagnosed with phantom limb pain in the United States.
• Existing treatment methods—such as general pain medication, mirror therapy and acupuncture—are ineffective for many patients.
• Because this pain is neurological, it is a prime target for treatment with psilocybin.

Complex Regional Pain Syndrome (CRPS)

• CRPS results from misfiring of pain signals within the brain after an injury, surgery, stroke or heart attack.
• We estimate that nearly 100,000 people have been diagnosed with CRPS in the United States.
• Current treatments are ineffective, leaving physicians with few options for suffering patients.

Key Partnerships

We’ve partnered with the Chronic Pain & Fatigue Research Center at the University of Michigan to advance our fibromyalgia studies—and we will be announcing partnerships for our clinical trials for phantom limb pain and complex regional pain syndrome soon.

Our Timeline

Based on existing preclinical and clinical data for the active ingredients in TRP-8802, we anticipate FDA support to proceed directly into Phase 2 trials.

Download our white paper describing our rationale for the use of psychedelics for chronic pain here:

Tryp Therapeutics White Paper on Chronic Pain

For millions of patients, relief can’t come soon enough.

A closer look at patient needs.

Binge Eating Disorder (BED)

• BED is characterized by recurring episodes of eating large quantities of food and feeling unable to stop.
• Nearly 30% of people seeking weight loss treatments show signs of BED.
• Up to 3.5% of females and 2.0% of males will develop BED at some point in their lives.

Hypothalamic Obesity

• Hypothalamic obesity, a rare disease, is caused by damage to the hypothalamus, which controls hunger.
• This damage is often caused by the surgical removal of a brain tumor.
• This condition can dominate patients’ day-to-day lives, and with no FDA-approved therapies available for the condition, patients have few options.

Key Partnerships

Tryp is collaborating with Jennifer Miller, M.D. from the University of Florida’s Division of Pediatric Endocrinology to evaluate the efficacy of our drug products. Dr. Miller is a world-renowned expert in overeating disorders such as binge eating and hypothalamic obesity. 

Our Timeline

Based on the well-established safety profile of psilocybin, we expect to advance directly into Phase 2a clinical trials.

Download our white paper describing our rationale for the use of psychedelics for overeating disorders here:

Tryp Therapeutics White Paper on Overeating Disorders

Tryp manufactures its own synthetic psilocybin—a unique asset among psychedelic drug development companies that gives us complete control over our product supply for clinical trials and ultimate commercialization.

You can expect excellence at every stage.

Our Partners

Curia (formerly AMRI) manufactures our Active Pharmaceutical Ingredient (API) through a proprietary process.

Alcami manufactures and develops analytical methods for our final drug products.

Current good manufacturing practice (cGMP)

• We employ cGMP in our manufacturing, the FDA standard for ensuring pharmaceutical quality.
• Adherence to cGMP regulations assures the identity, strength, quality and purity of our drug products.

Working at scale

• We are already scaled for full commercial quantities.
• We’ve already completed engineering batches for our API, and expect to have more than 2 kg of cGMP material in 2021.

We have established a unique manufacturing process to support our clinical trials and to supply drug products to patients once commercialized. 

Operational excellence is at the core of all we do at Tryp Therapeutics in our pursuit to provide effective treatments to millions of patients around the world.