Tetra Bio-Pharma (TSX:TBP, OTCQB:TBPMF) Inc shared a progress report on its development of its lead investigational drug QIXLEEF, a THC and CBD inhaled product for treatment of breakthrough pain.
The pharmaceutical firm said it is finalizing its strategy to procure raw materials while in discussions with potential partners ahead of the last stage of its drug development program.
READ: Tetra Bio-Pharma puts QIXLEEF study on the fast track with introduction of three more oral pain relief treatments for comparison
"Our team has made significant progress in bringing QIXLEEF to a late clinical development stage,” CEO Guy Chamberland told shareholders in a statement.
“We are dedicated to bringing this novel medication to patients and physicians as an alternative to opioids. It has been a challenging, but exciting journey to develop the first Rx inhaled cannabinoid-based drug."
QIXLEEF is a botanical inhaled drug product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The drug will be first indicated in patients with cancer suffering of uncontrolled breakthrough pain then in patients with advanced cancer with inadequately controlled pain.
Tetra is hoping to position QIXLEEF as a viable, safer, and non-opioid option for pain management.
The company is currently running a Phase 2 trial called REBORN1 that measures QIXLEEF’s efficacy against opioids in treating breakthrough pain in cancer patients. The company will leverage the long-term safety data gathered in an earlier trial to supplement the safety and efficacy data for the REBORN trials.
According to Tetra, the REBORN clinical strategy provides the fastest and lowest cost development program to bring QIXLEEF to market.
Ottawa-based Tetra Bio runs an FDA- and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
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