Tetra Bio-Pharma Initiates a Proof of Concept Clinical Trial for its Ophthalmic Drug in Dogs

A first of its kind synthetic cannabinoid medication to manage eye pain in the veterinary setting

Trial expected to be completed by April 30, 2020

OTTAWA, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-derived drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF) today announced the initiation of its clinical trial for its synthetic cannabinoid therapy (PPP003v) for the treatment of ophthalmic eye pain in the veterinary setting.

On February 8^th 2020, Tetra Bio-Pharma, in partnership with a veterinary ophthalmology team, initiated recruitment of an in-life phase proof of concept clinical trial in companion dogs with complications of indolent corneal ulcers, with the first dog to be treated on February 21, 2020. This Health Canada approved trial is designed to evaluate the safety, tolerability and potential efficacy of PPP003v, the company’s synthetic cannabinoid therapy, to ameliorate symptoms of this painful eye disease in dogs. Canine indolent corneal ulcers occur frequently in specific breeds of dogs⁵. Corneal ulcers are one of the most common painful eye disorders seen by veterinarians and untreated can cause severe pain, inflammation, scarring and vision loss⁶. 

PPP003v is Tetra’s proprietary veterinary ocular formulation for treating ocular pain and inflammation in companion animals.  PPP003v was developed and patented by Tetra’s Ophthalmic division and contains a non-controlled synthetic cannabinoid 2 receptor selective agent in an optimized formulation for topical delivery to the eye.  Extensive preclinical research has validated the Cannabinoid 2 receptor as a key drug target for reducing ocular inflammation and pain.^1-4

Tetra has previously carried out pre-clinical research confirming the efficacy of PPP003v for reducing symptoms of painful inflammatory eye disease. This study will be the first time a synthetic cannabinoid agent is used in companion animals with the goal of providing pet owners with an alternative ophthalmic pain medication. The veterinary health market was estimated at $17.3Bn in 2018 posting a robust CAGR of 4%⁷. This proof of concept clinical trial will be completed by April 30, 2020.

Based on positive results from this initial proof of concept clinical trial, Tetra will submit a new clinical trial application to the Veterinary Drugs Directorate of Health Canada to extend the findings of safety and efficacy for PPP003v, as well as commence regulatory filings of Veterinary New Drug Submission with Health Canada and New Animal Drug Application with the U.S. Food and Drug Administration to ensure that this drug will be available to the Canadian and U.S. markets for post operative eye pain.  Tetra is actively seeking interested partners to license its PPP0003v line for commercialization.