- Lead Candidate SAP-021 to be Developed on 505(b)(2) FDA Regulatory Pathway Based on Phase 1 Results Demonstrating Bioavailability in Comparison to Epidiolex®
- Patent Protected Production Technology Allows for Scalable Manufacturing of Orally Administered Capsules to Address Large Patient Populations
- Led by Highly Relevant Leadership Team with Deep Understanding of Cannabinoid Pharmaceutical Drug Development
LONDON & MELBOURNE, Australia & NEW YORK–(BUSINESS WIRE)–Avata Biosciences Ltd (‘Avata’), the former Sapient Therapeutics, is a clinical-stage biopharmaceutical company with a mission to improve the lives of patients living with neurological diseases. Meaning ‘to unlock’, Avata is emerging with a new name better aligned to unlock the potential of its proprietary technology to treat large patient populations. Avata is progressing clinical development of its lead product SAP-021, an orally administered capsule of pharmaceutical quality cannabidiol (CBD), towards the 505(b)(2) FDA Regulatory Pathway following a pre-IND meeting with the FDA.
Avata previously announced the positive Phase 1 pharmacokinetic results of its oral capsule, SAP-021, in comparison to Epidiolex®, an- oil-based cannabidiol solution approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC).
Avata has assembled a world-class leadership team with a deep scientific understanding of the pharmacological effects, formulation, and drug delivery requirements of cannabinoids. Many Avata executives have previously worked at GW Pharmaceuticals, the developer of Epidiolex®.
“Based on the positive Phase 1 data submitted to the FDA for review, we remain committed to a rapid development timeline via the 505(b)(2) FDA regulatory pathway,” said Rupert Haynes, Chief Executive Offer of Avata Biosciences. “Through our proprietary synthetic formulation, we have solved for the delivery of cannabidiol in an oral capsule that can be manufactured for diseases on a larger scale. With our eye on a full pipeline to include focal epilepsy, schizophrenia, and other neurological diseases, we intend to commence the next stage of clinical development for SAP-021 in H2 2024.”
Avata has now begun the next phase of fundraising of $110M to initiate a single pivotal Phase 3 study by Q4 2025, completing within 2027. Avata aims to achieve FDA approval and a US commercial launch in 2028. SAP-021 will quickly reach blockbuster status, with forecast annual revenues of more than $1B within four years from launch.
About Avata Biosciences
Avata Biosciences Ltd is a privately held biopharmaceutical company with a mission to improve the lives of patients living with neurological disease. The Company’s lead asset has successfully completed its first Phase 1 study and is advancing to the next stage of clinical development in 2024. With a leadership team comprised of neuroscience and cannabinoid medicine veterans, Avata is utilizing the experience gained in cannabinoid drug development to bring new prescription medicines to patients suffering from serious diseases. For more information, visit AvataBio.com.
Epidiolex® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.
Contacts
Julian Bryson, Investor Relations Director
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Tel: +44 (0) 7791 864652
