Avecho Biotechnology (ASX:AVE) said an independent data monitoring board recommended that the company's phase 3 clinical trial evaluating TPM-enhanced cannabidiol capsule for insomnia continue to the full planned enrolment of 519 participants, according to a Wednesday filing with the Australian bourse.
The data monitoring board issued the recommendation following an interim analysis that showed no serious adverse events across 244 initial participants.
"The interim analysis represents a major value-inflection point for the program, reducing clinical development risk and providing a defined pathway toward completion of the pivotal study," the company said.
Avecho added that it has already identified additional clinical sites to speed up the recruitment of the second patient cohort.
The company's shares gained 33% in recent Wednesday activity and earlier hit their highest since December 2020.