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Avecho Moves Phase III Insomnia Study Into Final Recruitment Stage

Avecho Moves Phase III Insomnia Study Into Final Recruitment Stage Source: Kapitales Research
Avecho Biotechnology Limited (ASX: AVE) has resumed participant enrolment for the concluding stage of its Phase III insomnia study involving its TPM®-based cannabidiol soft-gel formulation. The company intends to recruit about 320 more participants, with 519 people ultimately expected to complete the trial.
The next phase follows an encouraging independent assessment of interim data collected from 244 participants. The Data Monitoring Board supported proceeding with the existing study design and determined that additional enrolment beyond the original target was unnecessary. The safety assessment also found no serious adverse events among the groups examined.
Avecho has reopened enrolment across its current clinical network and plans to introduce further trial locations to improve recruitment momentum. After the additional sites become active, enrolment of the remaining participants is anticipated to take roughly 12 months. Completion of the study could enable Avecho to progress toward seeking Australian regulatory approval for its insomnia therapy.



 

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