London, UK and Melbourne, Australia, 19 December 2023: 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 Part B of its Phase 1 comparative trial evaluating the safety and pharmacokinetics of its innovative solid dose prescription cannabidiol (CBD), SAP021.

The positive results of this two-part Phase 1 trial demonstrate the tolerability and bioavailability of Sapient Therapeutics’ lead asset, SAP021, in comparison to Epidiolex®. The trial met all pharmacokinetic objectives, marking a significant milestone in the development of SAP021. As a result, the Company will be progressing this solid dose prescription-only CBD candidate into further clinical development and will meet with the U.S. Regulatory Authorities (Food and Drug Administration, FDA) at a Pre-IND meeting in H1 2024

Giles Moss, Chief Executive Officer of Sapient Therapeutics commented: “The success of Part B of our Phase 1 study confirms the promise for SAP021. When SAP021 was given with food the data were in alignment with both our expectations from Part A of the study and with previously published trial results. We now look forward to the next stage of clinical development. We would like to express our gratitude to all the volunteers and trial staff for their contribution to this successful result.” Sapient Therapeutics plans to utilise the FDA 505(b)(2) expedited regulatory pathway, with a view to making a solid dose CBD prescription medicine commercially available for US patients in the shortest possible timeframe.

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 successfully completed its first Phase 1 study with the Clinical Study Report (CSR) expected in H1 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.

Code: STx PR002, Date of preparation: Dec2023