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TBP REC'D 1YR EXTENSION FROM HC VETRINARY TO CLINICL TRIAL

[Humanist]

Tetra Bio-Pharma Re-activates Veterinary Clinical Study in Companion Animals
 
by @accesswire on 4 May 2021, 07:31
 
A first of its kind synthetic cannabinoid medication to manage eye pain in the veterinary setting

OTTAWA, ON / ACCESSWIRE / May 4, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the
"Company") (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development is pleased to announce that it has received authorization from the Veterinary Drugs Directorate of Health Canada for a one year extension to continue the clinical trial evaluating the safety, tolerability and potential efficacy of its veterinary ophthalmic drug, PPP-003v, in the treatment of indolent corneal ulcers in companion animals. Canine indolent corneal ulcers occur frequently in specific breeds of dogs¹. Corneal ulcers and non-ulcerative keratitis are among the most common painful eye disorders seen by veterinarians and if left untreated can result in pain, inflammation, scarring, and vision loss².
 
PPP-003v is Tetra's proprietary veterinary ocular formulation for treating ocular pain and inflammation in companion animals. PPP-003v was developed and patented by Tetra's ophthalmic division and contains a 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.^3-6.

In partnership with a clinical veterinary ophthalmologist team, Tetra initiated a pilot phase clinical trial in domestic dog as a proof-of-concept for its PPP-003v drug candidate for eye pain. While the completion of enrollment was planned by April 30, 2020, the trial was halted due to COVID-19 measures which restricted the ability of owners to bring their pets to the veterinary clinic for trial procedures.

"We are pleased with this regulatory authorization and the ability to re-activate the trial. While the active pharmaceutical ingredient used in the PPP-003v drug formulation is the same as the one used in ARDS-003, Tetra's innovative immunomodulator drug concurrently being developed for COVID-19, there is a major difference with how the drug is delivered. PPP-003v is intended to be used as a topical medication and is delivered as a sterile eye drop and ointment, while ARDS-003 is a sterile injectable nano-emulsion finished drug product," said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma.

This study will be the first time a synthetic cannabinoid agent is used clinically in companion animals with the goal of providing pet owners with an alternative ophthalmic medication for pain and inflammatory disease. 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 for a 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 eye pain and inflammation.

The veterinary health market was estimated at 148.8 million US$ in 2020 and is expected to reach 220.3 million US$ by the end of 2026, with the veterinary eye care market expected to see a compound annual growth rate (CAGR) of 5.7% during the next 5-year period⁷ reflecting an increase in global pet adoptions, prevalence of eye disorders in animals, and increased pet insurance driving health expenditures related to animal eye care.

"The PPP-003 program, including PPP-003v, represents a significant opportunity for Tetra since there is a substantial unmet medical need for painful inflammatory eye disease⁸. Tetra's veterinary ocular program is a key component of this program and the ongoing pilot phase trial will provide important data which can potentially be included as part of the pre-clinical data that will be submitted to support PPP-003 use in human clinical trials," said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma.
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