Therapix Biosciences Ltd. (TRPX:NASDAQ; THXBY:TASE) begins trading on NASDAQ March 22 under the ticker TRPX; the initial public offering is estimated to raise approximately $12 million.
The company's cannabinoid-based drug for Tourette Syndrome (TS) is in a proof-of-concept phase 2a trial at Yale University. The drug, THX-TS01, combines an FDA-approved synthetic THC—the main active ingredient in marijuana—called dronabinol with PEA, a substance that naturally occurs in food sources such as egg yolks and milk. PEA is approved for sale in Europe as "medical food." The company says the drug takes advantage of the "entourage effect," whereby the two compounds work synergistically for an enhanced effect.
The Phase 2a study is evaluating the safety, tolerability and efficacy of THX-TS01 in treating TS patients aged 18 to 60. The 18-person trial should conclude in Q3 2017 and the phase 2b study could start the same quarter. The company can use a 505(b)(2) regulatory strategy for FDA approval, taking advantage of prior studies of dronabinol done by third parties.
Therapix has filed an orphan drug designation for THX-TS01; the FDA has requested additional data. Dronabinol was approved by the FDA in the 1980s and is manufactured in the U.S. Because it is a synthetic formulation, it does not face the same hurdles that plant-based marijuana compounds do. The company believes that it will be able to comply with FDA's request on its orphan drug designation application with the data from the completion of its Phase 2a trial. Orphan drug status allows for stronger IP protection and pricing power.
The company is also developing a drug for mild cognitive impairment (MCI). Based on preclinical research at Tel Aviv University that suggested that ultra-low doses of THC could prevent and reverse cognitive decline, Therapix is developing THX-ULD01 that uses synthetic THC and is experimenting with sublingual and intra-nasal delivery systems that the company believes may enhance its bioavailability. Clinical trials should begin this year.
The World Alzheimer Report 2015 estimates that 46.8 million people have dementia worldwide, a figure that could climb to 74.7 million by 2030. No FDA-approved therapies exist for MCI.
Companies like Zynerba Pharmaceuticals Inc. (ZYNE:NASDAQ) illustrate the potential for firms using synthetic cannabinoid compounds. Zynerba recently announced that it has completed enrollment in the Phase 2 STAR 1 clinical trial evaluating ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures. The company also announced enrollment completion in the Phase 2 STOP clinical trial evaluating ZYN002 CBD gel for the treatment of osteoarthritis. Zynerba has around 13 million shares outstanding and a $240 million market cap.
Also in the spotlight is the $3-billion market-cap GW Pharmaceuticals Plc (GWPH:NASDAQ), which has 25.2 million shares outstanding. With operations both in the U.K. and the U.S., the firm focuses on the development of plant-derived cannabinoid treatments. Sativex, the first plant-derived prescription drug, is for spasticity due to multiple sclerosis, and is available in 31 countries outside the U.S. GW also has a drug for childhood epilepsy in Phase 3 trials.
Therapix's IPO (NASDAQ:TRPX) should raise $12 million and result in a total of approximately 3.1 million shares outstanding, for a total initial market cap of $18.6 million at the midpoint of its pricing range ($6 per share).
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