Former GW Pharma executives develop new CBD-based epilepsy drug

Avata Biosciences is developing CBD capsules for epilepsy and other neurological disorders, with a number of former GW Pharmaceutical executives on board.

The biopharmaceutical company, formerly known as Sapient Therapeutics, announced its new name in a press release issued on Monday May 13, as it progresses towards FDA approval of its lead drug candidate, SAP-021.

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

The results of a two-part Phase 1 trial, published in December 2023, demonstrated the «tolerability and bioavailability» of SAP021 compared with Epidiolex®, with the trial meeting all pharmacokinetic targets.

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

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

A number of former GW employees now hold senior positions 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, all of whom are listed as directors of the company.

Mr. Haynes commented, «Based on the positive Phase 1 data submitted for FDA review, we remain committed to a rapid development timeline via the FDA's 505(b)(2) regulatory pathway.»

«With our proprietary synthetic formulation, we have solved the problem of delivering cannabidiol in an oral capsule that can be manufactured on a larger scale to combat disease. With a view to a full pipeline including focal epilepsy, schizophrenia and other neurological diseases, we intend to initiate the next stage of SAP-021»s clinical development in the second half of 2024."

Following a pre-IND meeting with the FDA, Avata is aiming for approval by 2028, followed by commercial launch in the US, with annual revenues of over $1 billion expected within four years.

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