Tetra Bio-Pharma Provides an Update on Its Veterinary Ophthalmic Clinical Study with PPP003

Tetra’s sterile cannabinoid manufacturing facility fully validated and operational

Tetra’s subsidiary, Panag Pharma, ready to initiate the treatment phase of clinical trial of PPP003 for treatment of eye pain

OTTAWA, Jan. 28, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to provide an update on its veterinary clinical trial to evaluate the safety, tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of eye pain in companion animals with indolent corneal ulcers.

Following the authorization from Health Canada in 2019, Tetra has invested in the setup of a sterile cannabinoid drug manufacturing suite at the facility in New Brunswick which has been used to manufacture validated batches of sterile PPP003 drug for use in its ophthalmic drug development program. The design of the sterile suite, implementation of cGMPs, and validation of the sterile process was performed by Tetra’s manufacturing and quality compliance staff. The validated batches of sterile drug will be used in the planned clinical trial in companion animals with indolent corneal ulcers, which is expected to begin in 2020. A similar manufacturing process is required for the clinical trials in human patients with eye diseases such as painful dry eye and uveitis.    

“We are thrilled to have successfully created and validated a facility to manufacture batches of sterile drugs for our ophthalmic drug development program.  In June 2019, the U.S. FDA validated our ophthalmic research program and with this significant milestone achieved, we are in an excellent position to bring PPP003 to human clinical trials later this year," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma.  “Along with our PPP011 and PPP001 drug development programs, this drug development program is one of Tetra’s corporate priorities, since there is a significant unmet medical need for ophthalmic drugs in both companion animals and humans. PPP003 was selected because it is a non-controlled cannabinoid and will favor global market penetration.”