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.

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) is a biopharmaceutical pioneer in immunomodulator drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us 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 we do, 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.

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

References:

1. Moore PA. Diagnosis and management of chronic corneal epithelial defects (indolent corneal ulcerations). Clin Tech Sm An Pract 2003; 18(3):168-77.
2. Ledbetter E, Gilger B. Diseases and Surgery of the Canine Cornea and Sclera. In: Gelatt K, Gilger B, Kern T, eds. Veterinary Ophthalmology. 5th ed. Ames, IA: John Wiley & Sons, Inc.; 2013: 976-1049.
3. Porter RF et al. Selective Cannabinoid 2 Receptor Agonists as Potential Therapeutic Drugs for the Treatment of Endotoxin-Induced Uveitis. Molecules. 2019 Sep 13;24(18). pii: E3338. doi: 10.3390/molecules24183338. PubMedPMID: 31540271; PubMed Central PMCID: PMC6767236.
4. Toguri JT et al. Inflammation and CB(2) signaling drive novel changes in the ocular lipidome and regulate immune cell activity in the eye. Prostaglandins Other Lipid Mediat. 2018 Nov;139:54-62. doi:10.1016/j.prostaglandins.2018.09.004. Epub 2018 Sep 16. PubMed PMID: 30232034.
5. Thapa D et al. The Cannabinoids Δ(8)THC, CBD, and HU-308 Act via Distinct Receptors to Reduce Corneal Pain and Inflammation. Cannabis Cannabinoid Res. 2018 Feb 1;3(1):11-20. doi: 10.1089/can.2017.0041. eCollection 2018. PubMed PMID: 29450258; PubMed Central PMCID: PMC5812319.
6. Toguri JT et al. Anti-inflammatory effects of cannabinoid CB(2) receptor activation inendotoxin-induced uveitis. Br J Pharmacol. 2014 Mar;171(6):1448-61. doi: 10.1111/bph.12545. PubMed PMID: 24308861; PubMed Central PMCID: PMC3954484.
7. 360 Research Reports. (2020). GLOBAL PET EYE CARE PRODUCTS MARKET RESEARCH REPORT 2020. Obtained from: https://www.360researchreports.com/global-pet-eye-care-products-market-15076241. Accessed May 2, 2021
8. Cursiefen C, Cordeiro F, Cunha-Vaz J, Wheeler-Schilling T, Scholl H, P, N: Unmet Needs in Ophthalmology: A European Vision Institute-Consensus Roadmap 2019-2025. Ophthalmic Res 2019;62:123-133. doi: 10.1159/000501374

Forward-Looking Statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.:
Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: investors@tetrabiopharma.com
media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma