Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) has announced it will reactivate a clinical trial to evaluate the safety, tolerability, and potential efficacy of its veterinary ophthalmic drug PPP-003v as a treatment of indolent corneal ulcers in companion animals.
The company’s announcement comes after it received authorization from the Veterinary Drugs Directorate of Health Canada for a one-year extension to continue the clinical trial.
In partnership with a clinical veterinary ophthalmologist team, Tetra said it had 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.
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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.
The company said PPP-003v 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.
“We are pleased with this regulatory authorization and the ability to re-activate the trial,” said Tetra CEO Dr Guy Chamberland in a statement.
“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.”
Tetra said the 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 said it 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 US Food and Drug Administration (FDA) to ensure that the drug will be available to the Canadian and US markets for eye pain and inflammation.
Dr Chamberland added: “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.”
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