Avata Biosciences Emerges to Develop Solid Dose Cannabinoid Medicines for Epilepsy and Other Neurological Diseases
May 13 2024 - 3:00AM
Business Wire
- 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
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.
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Julian Bryson, Investor Relations Director jbryson@avatabio.com
Tel: +44 (0) 7791 864652