Tetra Bio-Pharma Provides Management Update on COVID-19

OTTAWA, March 23, 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, today would like to announce that it has ensured that all of its employees work under conditions that comply with federal and provincial public health recommendations. Additionally, following the completion of its $17.8 M financing in February and early March, the Company is in a good position to maintain its drug development programs.

Regulatory activities have not slowed down despite the COVID-19 crisis. These activities are now performed by Tetra’s employees from their home offices. Tetra confirms that it will continue all planned Clinical Trial Applications (CTA), DIN (Drug Identification Number applications), veterinary drug clinical trial applications (Experimental Studies Certificate; ESC) and Pre-Submission meetings in Canada and Investigational New Drug Applications (IND), veterinary IND applications, Pre-IND meetings (PIND) (including Type B and C meetings), Orphan Drug Designation (ODD) applications in the United States. European regulatory activities will also continue.

Tetra’s clinical research team is working to increase the number of clinical sites in Canada and the USA so that it can accelerate the enrolment of patients when the crisis is over. To date the ophthalmic clinical trial has been moving along as per expected timelines. Half of the patient dogs have completed the treatment phase of the study. There was no treatment related adverse events. Tetra expects to complete this trial in this fiscal quarter (end of April) or early in fiscal Q3 and will then report the key outcomes of the study. The corporation has already begun planning the second trial for the treatment of canine indolent corneal ulcers. This second trial will involve regulatory filings in both Canada and the USA. The IND-enabling toxicology studies with HU308 for the human ocular trials are continuing as planned.

During this crisis period, Tetra will be submitting both an IND and CTA to initiate a clinical trial in Canada and the USA for its Orphan Drug HCC011. The corporation will continue forward with its PIND meeting request to discuss with the FDA the marketing requirements for this Orphan Drug that would benefit from FDA’s expedited programs as well as the 505(b)(2) NDA (New Drug Application) regulatory pathway.