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BOD: Phase IIb CBD-insomnia trial recruitment complete


Published 04-APR-2023 10:46 A.M.


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Bod Science (ASX:BOD) today announced that it has recruited the 198 participants required for its upcoming Phase IIb clinical trial for its new CBD insomnia product.

The planned 8 week clinical trial, to be undertaken by Australia’s leading sleep research organisation - the Woolcock Institute of Medical Research, will examine the efficacy of a unique CBD formulation on symptoms associated with insomnia.

The trial will be a double blind, randomised and placebo-controlled investigation into the effect of administering 50mg or 100mg oral doses of a proprietary CBD product per day.

The product is intended for Schedule 3 (pharmacist only) registration in the Australian market. Importantly, Schedule 3 products can be sold to Australian consumers in pharmacies over the counter (OTC) without needing a prescription.

While there are no CBD products approved for OTC sale in pharmacies yet, BOD hopes to change this in the near term. In preparation, BOD has entered into a 5 year distribution agreement with Arrotex Pharmaceuticals, Australia’s largest generic pharmaceutical and private label OTC medicines company.

Completion of the Phase IIb clinical trial will be a significant step in the research and development for the low dose CBD product and should provide enough data for BOD to apply to register the with the TGA.

With all 198 participants now recruited, BOD met its target of completing recruitment by the end of March

The 8-week treatment period will be followed by a safety follow-up on week 12 for each patient. Then, once the last patient completes the trial, BOD will immediately move to the data analysis stage.

Today’s announcement is a step closer to BOD achieving our Objective #2 as we outlined in our BOD Investment Memo last year, and with the completion of trial participant recruitment we can check off this milestone:

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