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Avata Biosciences to Focus on Creating Solid Dose Cannabinoid Therapies for Epilepsy and Neurological Conditions

Monday, May 13, 2024

Avata Biosciences Ltd, formerly known as Sapient Therapeutics, is a company in the clinical-stage biopharmaceutical sector that focuses on enhancing the lives of patients with neurological diseases. The company's name, "Avata," which means "to unlock," reflects its dedication to unlocking the potential of its proprietary technology to address a broad range of patient needs. Avata is currently moving forward with the clinical development of SAP-021, its primary product, which is an orally administered pharmaceutical-grade cannabidiol (CBD) capsule. They are pursuing the 505(b)(2) FDA Regulatory Pathway after a successful pre-IND meeting with the FDA.

Recent announcements by Avata have highlighted positive Phase 1 pharmacokinetic results for SAP-021. These results demonstrate its superiority over Epidiolex®, an FDA-approved oil-based cannabidiol solution for treating seizures associated with specific neurological conditions. Avata has brought together a distinguished leadership team with expertise in cannabinoid pharmacology, formulation, and drug delivery, with many team members previously employed by GW Pharmaceuticals, the creators of Epidiolex®.

Avata Biosciences, has reiterated the company's commitment to a swift development process through the 505(b)(2) FDA regulatory pathway. This commitment is backed by their proprietary synthetic formulation, which enables scalable production of cannabidiol capsules. Avata plans to expand its pipeline to include focal epilepsy, schizophrenia, and other neurological disorders, with the next phase of SAP-021's clinical development slated to begin in the second half of 2024.

To support these plans, Avata has initiated a new fundraising round of $110 million. This funding will facilitate the launch of a pivotal Phase 3 study by the fourth quarter of 2025, with completion anticipated in 2027. Avata aims to secure FDA approval and launch SAP-021 in the US market by 2028. The company anticipates rapid growth, with SAP-021 expected to achieve blockbuster status and generate annual revenues exceeding $1 billion within four years of its launch.

 

Source: businesswire.com

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