LONDON & MELBOURNE, Australia–(BUSINESS WIRE)–Sapient Therapeutics Ltd (“Sapient Therapeutics”), a pioneering biopharmaceutical company specialising in neuroscience drug discovery and early clinical development, is pleased to announce the successful completion of its Phase 1 Part A comparative trial evaluating the safety and pharmacokinetics of its innovative solid dose prescription cannabidiol (CBD), SAP021.
The positive results of this Phase 1 Part A trial demonstrate the tolerability and bioavailability of Sapient Therapeutics lead asset, SAP021, in comparison to Epidiolex®. The trial met all pharmacokinetic requirements, marking a significant milestone in the development of SAP021. As a result, the Company has progressed this solid dose CBD candidate into Part B of the trial with full results expected in H1 2024.
Giles Moss, Chief Executive Officer of Sapient Therapeutics commented: “A solid dose formulation of CBD could provide additional clinical benefit to patients experiencing and suffering from serious neurological diseases. These initial results confirm the early potential of SAP021, are consistent with our best-case scenario at this stage and set us up well for continuation of this trial to a successful outcome”.
Sapient Therapeutics plans to utilise an U.S. Food and Drug Administration (FDA) expedited and de-risked 505(b)(2) regulatory pathway, with a view to making a solid dose CBD prescription medicine commercially available for US patients in late H2 2027.
For and on behalf of Sapient Therapeutics Ltd:
Sapient Therapeutics is a UK based biopharmaceutical company focused on neuroscience drug discovery and early clinical development. Our lead asset (SAP021) has commenced Phase 1 studies and will complete in 2024. Our leadership team is comprised of neuroscience and cannabinoid medicine veterans. Together we are utilising the experience gained in cannabinoid drug development to bring new prescription medicines to patients suffering from serious diseases.
STx PR001 Nov2023
Giles Moss, CEO