Tetra Bio-Pharma Inc, a cannabinoid-derived drug discovery and development company, revealed that it received positive feedback from a Scientific Advice Assessment (SAA) report from the Malta Medicines Authority on its drug development plan for QIXLEEF and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC.
QIXLEEF is the Ottawa, Canada-based company's inhaled proprietary drug which has a fixed ratio of THC and CBD. The medication is inhaled through a Class II medical vaporizer.
The SAA report endorses Tetra's proposed plan to address the nonclinical safety requirements for submitting a MAA for its proprietary cannabinoid-based drug candidate. “The SAA report endorses the company's quality program for QIXLEEF as a medicine,” said the company. In both cases, the SAA report provides guidance on requirements for MAA approval.
In addition, the company said the SAA report provides "clarity on clinical requirements for registration in Europe".
READ: Tetra Bio-Pharma puts QIXLEEF study on the fast track with introduction of three more oral pain relief treatments for comparison
The SAA report discusses the assessment of both the PLENITUDE and REBORN clinical programs with regards to a MAA. The company said the SAA report provides “guidance on the endpoints and other aspects of the protocol”.
Tetra Bio-Pharma said the REBORN2 trial was identified as “pivotal for the MAA because of its dose-response endpoint requirements of the directive”. Depending on the outcome in the REBORN1 and REBORN2 clinical trials, full marketing authorization would require confirmation of the outcome of REBORN1.
In July, Tetra Bio-Pharma said it is accelerating its REBORN1 trial of QIXLEEF after receiving approval allowing the study to compare three other immediate release oral opioids. Initially, the study was a direct safety and efficacy comparison between QIXLEEF and oral morphine sulfate immediate release, but the amended protocol introduces oral morphine sulfate immediate release, oral hydromorphone immediate release, or oral oxycodone immediate release as well.
This will allow the company to demonstrate the potential efficacy of QIXLEEF against a class of immediate relief oral opioids.
In a statement, Tetra Bio-Pharma CEO Dr Guy Chamberland said: "The endorsement of the proposed nonclinical and quality programs is an exciting achievement that affirms the robustness of our drug development approach. The Medicine Authority's response confirms that our development strategy, adjusted with their guidance on the clinical program, could allow QIXLEEF to satisfy the requirements of article 8 of the Directive.”
“The timing of this news is important for us as we try to finalize a single global clinical program for bringing QIXLEEF to patients."
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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