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  • Tetra Bio-Pharma (TBP) has received authorization to continue the clinical trial evaluation of its veterinary ophthalmic drug, PPP-003v
  • PPP-003v is Tetra’s proprietary veterinary ocular formulation for treating ocular pain and inflammation in companion animals
  • This study will be the first time a synthetic cannabinoid agent is used clinically in companion animals
  • Tetra Bio-Pharma is a leader in cannabinoid-derived drug development
  • Tetra Bio-Pharma (TBP) opened trading at C$0.49 per share

Tetra Bio-Pharma (TBP) has received authorization from the Veterinary Drugs Directorate of Health Canada to continue evaluating its veterinary ophthalmic drug, PPP-003v.

PPP-003v is Tetra’s proprietary veterinary ocular formulation for treating ocular pain and inflammation 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 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.

In partnership with a clinical veterinary ophthalmologist team, Tetra initiated a pilot phase clinical trial in domestic dogs 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 and commence regulatory filings for a New Animal Drug Application with the U.S. Food and Drug Administration.

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 period.

“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.

Tetra Bio-Pharma is a leader in cannabinoid-derived drug development. Tetra Bio-Pharma is focused on drug development programs in Inflammation, Pain, Ophthalmology and Oncology, aimed at bringing novel drugs and treatments to patients and their healthcare providers.

Tetra Bio-Pharma (TBP) opened trading at C$0.49 per share.

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