Ex-GW Pharma bosses develop new CBD-based epilepsy drug

Ex-GW Pharma bosses develop new CBD-based epilepsy drug


Avata Biosciences is developing solid-dose cannabinoid drugs for epilepsy and other neurological disorders, with a number of former GW Pharmaceutical bosses on board.

The clinical-stage biopharmaceutical company, formerly known as Sapient Therapeutics, announced its new name, which means “unlock,” in a Press release on Monday, May 13, as it moves toward FDA approval of its lead drug candidate, SAP-021.

SAP-021 is an orally administered capsule containing pharmaceutical grade CBD, which could potentially rival Epidiolex®, currently the only cannabis-based drug approved by regulators for the treatment of seizures associated with rare forms of epilepsy, including Lennox-Gastaut syndrome (LGS). ), Dravet syndrome and tuberous sclerosis complex (TSC).

Results from a two-part phase 1 trial, published in December 2023, demonstrated the “tolerability and bioavailability” of SAP021, compared to Epidiolex®, with the trial meeting all pharmacokinetic endpoints.

Epidiolex® produced by Jazz Pharmaceuticals (formerly GW Pharmaceuticals), currently accounts for the majority of global sales of pharmaceutical cannabis, with an estimated market share of around 76% projected by 2023, according to a recent report.

According to the FDA database, the drug received approval in 2018 for the treatment of seizures in LGS and Dravet syndrome, followed by TSC in 2020. The exclusivity periods will expire in 2025 and 2027, respectively .

A number of former GW employees now hold executive roles at Avata, including CEO Rupert Haynes, who is GW’s former head of global marketing, chief medical officer Dr Andrew Saich and head of intellectual property, Dr. Chris Hayes, who are listed as company directors.

Haynes commented, “Based on the positive Phase 1 data submitted to the FDA for review, we remain committed to an accelerated development schedule through the FDA’s 505(b)(2) regulatory pathway.

“Through our proprietary synthetic formulation, we have solved the delivery of cannabidiol in an oral capsule that can be manufactured for larger-scale diseases. With our sights set on a comprehensive pipeline to include focal epilepsy, the schizophrenia and other neurological diseases, we intend to begin the next stage of clinical development of SAP-021 in the second half of 2024.”

Following a pre-IND meeting with the FDA, Avata is targeting approval in 2028, followed by a commercial launch in the US, with annual revenue of more than $1 billion expected within four years.

Avata is raising $110 million to initiate a single pivotal Phase 3 study in the fourth quarter of 2025, to be completed in 2027.

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