According to a report by Cannabis Health
Avata Biosciences is developing solid-dose cannabinoid drugs for epilepsy and other neurological disorders, and includes a number of former GW Pharmaceutical bosses.
The clinical-stage biopharmaceutical company formerly known as Sapient Therapeutics “unlocks” in a press release on Monday, May 13, as it moves toward FDA approval of its lead drug candidate, SAP-021. announced a new company name that means
SAP-021 is an orally administered capsule containing pharmaceutical-grade CBD and is currently the only cannabis cannabis plant approved by regulators for the treatment of seizures associated with rare forms of epilepsy, including Lennox-Gastaut syndrome (LGS). It may be comparable to the base drug Epidiolex®. ), Dravet syndrome, and tuberous sclerosis complex (TSC).
Results from a two-part Phase 1 study published in December 2023 demonstrated the “tolerability and bioavailability” of SAP021 compared to Epidiolex®, and the study met all pharmacokinetic objectives. Ta.
Epidiolex®, manufactured by Jazz Pharmaceuticals (formerly GW Pharmaceuticals), currently accounts for the majority of global medicinal cannabis sales, with an estimated market share expected to increase by 2023, according to a recent report. It is predicted to be around 76%.
The drug was approved for the treatment of LGS and Dravet syndrome seizures in 2018, and subsequently received approval from the TSC in 2020, according to the FDA database. The exclusivity periods are scheduled to end in 2025 and 2027, respectively.
Many former GW employees now work at Avatar, including CEO Rupert Haynes, former global head of marketing, Dr. Andrew Syke, chief medical director, and Dr. Chris Hayes, head of intellectual property. He holds an important position. Director of the company.
Mr Haynes commented: “Based on the positive Phase 1 data submitted to the FDA for review, we remain committed to an expedited development schedule through the 505(b)(2) FDA regulatory pathway.
“Through our proprietary synthetic formulation, we have solved the delivery of cannabidiol in oral capsules that can be manufactured at scale for diseases. We are looking at a complete pipeline including focal epilepsy, schizophrenia, and other neurological diseases. We plan to begin the next phase of clinical development of SAP-021 in the second half of 2024.”
Following pre-IND meetings with the FDA, Avata aims to win approval by 2028 and then commercially launch in the U.S., with annual revenue projected to exceed $1 billion within four years. are.
Avata is raising $110 million to begin a single pivotal Phase 3 trial by Q4 2025 and complete within 2027.
