As reported by Cannabis health
Avata Biosciences, a company with former GW Pharmaceutical executives on board, is developing solid-dose cannabinoid medicine for epilepsy as well as other neurological disorders.
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 expire respectively in 2025 & 2027.
Avata has a number of former GW employees in executive positions. These include CEO Rupert Haynes who was GW’s former Global Marketing Chief, Dr Andrew Saich, the Chief Medical Director and Dr Chris Hayes who is listed as a company director.
Haynes said: “Based on positive Phase 1 data that we submitted to FDA to be reviewed, we remain committed towards a rapid development schedule via the 505b(2) FDA regulatory pathway.
We have developed a proprietary synthetic formulation that allows us to deliver cannabidiol into an oral capsule for larger-scale diseases. In order to have a complete pipeline that includes focal epilepsy and schizophrenia, as well as other neurological disorders, we plan to start the next stage in clinical development of SAP-021 during H2 2024.
Avata, following a pre IND meeting with FDA, aims to receive approval by 2028. This will be followed by a US commercial launch, with revenues exceeding $1 billion per year forecast in four years.
Avata will raise $110 million for a pivotal Phase III study to be initiated by Q4 of 2025 and completed within 2027.