Avecho Biotechnology commences manufacturing for Phase 3 insomnia study

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Avecho Biotechnology (ASX:AVE) has commenced manufacturing activities to support its pivotal Phase 3 clinical trial with the US-based contract manufacturing organisation, Procaps Group.

Procaps Group develops pharmaceutical and nutraceutical solutions, medicines, and hospital supplies across more than 50 countries and all five continents. It has a direct presence in 13 countries in the Americas where it develops, manufactures, and markets over-the-counter pharmaceutical products, prescription pharmaceutical drugs, nutritional supplements and high-potency clinical solutions.

Procaps Group has experience in the manufacture of pharmaceutical cannabinoid products and is currently manufacturing US FDA-approved dronabinol (synthetic tetrahydrocannabinol) capsules for sale in the US.

Avecho said it conducted due diligence on contract manufacturers throughout 2022 to identify options for the global pharmaceutical and consumer markets. It said the manufacture of its CBD capsule was transferred to multiple manufacturing candidates, and small-scale batches were placed on short-term stability.

Avecho CEO Dr Paul Gavin said, “The initial entitlement offer to shareholders raised sufficient capital to kick-off the manufacturing activities associated with our pivotal Phase III trial. We can’t commence the trial until the investigational product is manufactured, so raising sufficient capital to commence these activities now while we conclude raising capital was critical. We are delighted that Procaps Group will be joining us on this journey as we prepare for this defining late-stage clinical trial which will be an exciting milestone for our Company and the biotechnology industry at large. Importantly for Avecho, Procaps Group are a manufacturing option for CBD capsules able to be sold in further consumer markets.”