Zelira Therapeutics Ltd. announced the successful enrolment of 40 out of 60 patients in the clinical trial for diabetic nerve pain, announced 12 July 2021. The trial was designed and approved as a multi-arm, head-to-head trial against a major Big Pharmaceutical company's multi-billion dollar revenue drug, using Zelira's proprietary, patent protected product. The trial is powered to show statistical significance with 60 subjects (20 subjects in each arm). In May 2022, Zelira announced the complete enrolment of 20 patients in arm 1, being the investigative drug arm of the trial. An additional 20 subjects currently using the Big Pharmaceutical company drug, have been successfully enrolled. The second arm will serve as an active reference arm for the
trial, with the trial designed where the third arm will evaluate the synergistic effect (combined effects) of the reference drug.
Zelira expects to complete trial enrolment and provide a trial read out in fourth quarter of 2022.