As reported by Cannabis Health
Avata Biosciences is developing solid dose cannabinoid medicines for epilepsy and other neurological disorders, with a number of former GW Pharmaceutical bosses on board.
The clinical stage biopharma company, formerly known as Sapient Therapeutics, announced its new name, meaning ‘to unlock’, in a press release on Monday 13 May, as it progresses towards FDA approval of its lead drug candidate, SAP-021.
SAP-021 is an orally-administered capsule containing pharmaceutical-grade CBD, which could rival Epidiolex®, currently the only cannabis-based medicinal product approved by regulators in 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, in comparison to Epidiolex®, with the trial meeting all pharmacokinetic objectives.
Epidiolex® produced by Jazz Pharmaceuticals (formerly GW Pharmaceuticals), currently makes up the majority of global pharmaceutical cannabis sales, with an estimated market share of around 76% projected for 2023, according to a recent report.
According to the FDA database, the drug received authorisation in 2018 for the treatment of seizures in 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 employees of GW are now holding executive positions at Avata, including CEO Rupert Haynes, who is GW’s former global marketing chief, Chief Medical Director, Dr Andrew Saich and Head of Intellectual Property, Dr Chris Hayes, who are all listed as company directors.
Haynes commented: “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.
“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.”
Following a pre-IND meeting with the FDA, Avata is aiming to achieve approval by 2028, followed by a commercial launch in the US, with annual revenues of more than $1 billion forecast within four years.
Avata is raising $110 million to initiate a single pivotal Phase 3 study by Q4 2025, completing within 2027.
