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Tetra Bio-Pharma receives extension for PPP-003v trials

2021-05-04 11:34 ET - News Release

Dr. Guy Chamberland reports


Tetra Bio-Pharma Inc. 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 dogs. 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 loss.

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.

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 enrolment 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 reactivate 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, chief executive officer and chief revenue officer 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 PPP-003v, 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 (U.S.) in 2020 and is expected to reach $220.3-million (U.S.) by the end of 2026, with the veterinary eye care market expected to see a compound annual growth rate of 5.7 per cent during the next five-year period 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 disease. 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. Chamberland.

About Tetra Bio-Pharma Inc.

Tetra Bio-Pharma is a biopharmaceutical pioneer in immunomodulator drug discovery and development with an FDA and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company's evidence-based scientific approach has enabled it to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation and oncology. With patients at the core of what the company does, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

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