New IPO targeting Tourette's syndrome with synthetic THC drug
Other than a flurry of trading activity in the days following its late-March IPO, things have been relatively quiet for Therapix Biosciences’ (NASDAQ: TRPX) stock. The 10-day average volume has retreated to around 100,000 shares a day. But with a series of positive developments announced in recent weeks, shares have begun climbing steadily higher, currently up more than 20% from where its IPO was priced.
Phase 2a Study Underway
TRPX is unique in the cannabis space. It’s developing drugs for potential blockbuster indications using various formulations of cannabinoids and synthetic THC, and its bringing these drugs to market via clinical trials and FDA submissions.
A Phase 2a study is underway for TRPX’s lead asset (THX-TSO1) – a drug targeting Tourette’s syndrome. Considered an orphan disease by the FDA, Tourette’s afflicts an estimated 138,000 children in the U.S.
Only three drugs have been approved by the FDA to treat Tourette’s. Severe side effects associated with these drugs has resulted in limited use.
Several studies suggest that cannabis and THC may be effective in the treatment of Tourette’s, without the severe side effects. THX-TSO1 combines a synthetic endocannabinoid analog (PEA) with FDA-approved synthetic THC (dronabinol, aka Marinol®).
The Phase 2a study for THX-TSO1 that kicked off in December 2016 at Yale Medical Center is part of a 505(b)(2) regulatory strategy for FDA approval, which requires the use of approved active ingredients. This should lead to an abbreviated development cycle and shorter time to market.
Data read-out from the Phase 2a study is expected in the third quarter, with a Phase 2b/3 study expected to commence before year-end.
Near-Term Phase 1 Trial for Mild Cognitive Impairment
Cannabis has been shown to cause long-term cognitive deficits in chronic users, manifested as impairment in attention, memory, or executive functions. Paradoxically, ultra-low doses of THC have been shown to prevent and reverse cognitive decline in pre-clinical trials.
These findings were demonstrated by Professor Yosef Sarne at Tel Aviv University in 2014.
As with its lead asset for Tourette’s, TRPX is basing its development program for Mild Cognitive Impairment (MCI) on the FDA-approved synthetic cannabinoid Marinol® (dronabinol).
A Phase 1 study with healthy volunteers is kicking off in the second quarter to demonstrate safety and bioavailability for TRPX’s MCI program, known as THX-ULD01. A POC Phase 2 study to demonstrate efficacy is expected to follow in the first half of 2018.
TRPX will initially target patients with traumatic brain injuries and/or concussions.
Overall, there are an estimated 47 million people with dementia globally, with that number expected to rise to 75 million by 2030.
The global economic cost of dementia in 2015 was an estimated $818 billion, a 35% increase from 2010.
Currently there is no FDA-approved treatment or therapy for MCI.
Additional Development Opportunities
Studies in several clinically relevant applications indicate THC may possess antibacterial properties, positioning TRPX’s unique platform technology as a potential solution to the urgent unmet need for new anti-bacterial agents.
TRPX intends to use its entourage technology (combining THC and PEA) to potentiate the efficacy of existing antibiotic drugs, especially in antibiotic-resistant bacteria strains.
The antibiotics market is forecasted to reach $57 billion by 2024, according to data from Grandview Research.
TRPX is also exploring the application of its technology platform in patients with chronic pain conditions. Transparency Market Research estimates the pain management therapy market will reach $83 billion by 2024.
TRPX has assembled an all-star team of executives and advisors.
Dr. Ascher Shmulewitz, chairman of the board, has founded over two dozen life science companies and led multiple companies to successful exits. A prolific inventor and serial entrepreneur in biomedical technologies, Dr. Shmulewitz brings a wealth of experience to the team.
Other notable team members include Doron Ben Ami, chief strategy officer, who brings more than 20 years of management experience, including senior leadership roles at multinational pharma companies such as Merck and Lundbeck, and Dr. Elran Haber, CEO, who has served in key roles at both private and public companies in the life science space.
On its scientific advisory board, TRPX benefits from the experience of experts in Tourette’s and cognitive disorders, including Yale’s Professor James Leckman, a prominent international expert in the research and treatment of Tourette’s, and Professor Michael Davidson, Chairman of the Stuckinski Centre for Alzheimer’s Disease Research in Israel.
Significantly Undervalue Compared to Peers
Despite near-term expectations for multiple positive developments in its development programs, TRPX remains significantly undervalued compared to its peers.
Zynerba Pharmaceuticals (NASDAQ: ZYNE), which is developing next-generation synthetic cannabinoid therapeutics for transdermal delivery for patients with high unmet medical needs like epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and peripheral neuropathic pain, trades for a market cap of around $330 million. TRPX trades for less than $30 million.
GW Pharmaceuticals (NASDAQ: GWPH) is also developing cannabinoid-based drugs, yet trades for a market cap of nearly $3 billion.
As investors become aware of TRPX, and its promising near-term milestone achievements, we anticipate this valuation gap will begin to close. Even a modest reduction in the gap will create massive upside for fast-acting investors.
Learn more by visiting TRPX's stock page.
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Therapix (NASDAQ: TRPX) is a client of RedChip Companies, Inc. TRPX agreed to pay RedChip Companies, Inc. a monthly cash fee for four (4) months of RedChip investor awareness and consulting services.