ASX-listed Zelira Therapeutics watched its share price jump 230% on Monday after the company disclosed that its cannabinoid-based treatment for diabetic nerve pain outperformed Pfizer's blockbuster drug Lyrica in a comparative study.
The company's internally developed ZLT-L-007 treatment delivered pain score reductions that exceeded those seen with Lyrica by as much as four times in some cases.
The multi-arm, head-to-head study concluded that the Zelira product was safe and well-tolerated, with results described as having "compelling outcomes" that support the case for advancing the drug into formal clinical trials in the United States.
Those findings drove Zelira's share price up more than 250% at its peak before it pulled back. Shares opened the following day at A$3.05 and had slipped 15% to $2.60 by mid-morning.
The US-based research, carried out in collaboration with Affinity Bio Partners, was an observational, non-blinded study with 60 participants. Of those, 22 received Lyrica/pregabalin, 20 received both treatments, and 18 received only Zelira's medication.
Principal investigator Dr Bryan Doner described the research as "groundbreaking".
"The implications of these results for patients are incredibly promising and thrilling," he said. "Through this rigorously designed study we have demonstrated that ZLT-L-007 is a safe, effective and well-tolerated alternative for patients who would typically seek a Lyrica level of pain relief."
Zelira chairman Osagie Imasogie noted that in certain cases ZLT-L-007 delivered up to four times the observed pain relief compared to Lyrica.
“This compelling outcome gives us confidence to evaluate the further progression of ZLT-L-007 into formal FDA clinical trials,” he said.
“Our company remains focused on providing relief to patients and creating new cannabinoid derived drugs to deliver clinically validated safe and efficacious solutions to patients in need, across several therapeutic areas.”
Zelira chief executive and managing director Dr Oludare Odumosu said the drug showed meaningful reductions in pain severity, particularly at the 60- and 90-day marks.
“These results mark a significant milestone for Zelira, further supporting and validating our launch, learn and develop strategy that has enabled us to generate this level of compelling clinical data validation,” he said.
