Categories: Wire Stories

Sapient Therapeutics Announces Positive Phase 1 Results in Part B of Its Solid Dose Prescription CBD Study

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 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

Contacts

Giles Moss, CEO

gmoss@sapienttx.com

Alex

Recent Posts

Wildberries to More Than Double Warehouse Capacity in 2025

MOSCOW, RUSSIA - Media OutReach Newswire - 24 December 2024 - Wildberries, a leading e-commerce…

9 minutes ago

JustMarkets Celebrates Key Milestones From 2024

HO CHI MINH CITY, VIETNAM - Media OutReach Newswire - 24 December 2024 - JustMarkets…

2 hours ago

Thailand Shines at ACES Awards 2024: Celebrating Leadership, Sustainability, and Innovation Across Industries

BANGKOK, THAILAND - Media OutReach Newswire - 24 December 2024 - The Asia Corporate Excellence…

2 hours ago

China Focus: Technology sows seeds of hope in combating desertification

HOHHOT, CHINA - Media OutReach Newswire - 23 December 2024 - China's National Forestry and…

12 hours ago

Novautek Honored with the “Outstanding SME ESG and Business Performance Award”

HONG KONG SAR - EQS Newswire - 23 December 2024 - Novautek Autonomous Driving Limited…

14 hours ago

V-GREEN and Xanh SM Indonesia sign MoU with Lippo for comprehensive green ecosystem in Indonesia

JAKARTA, INDONESIA - Media OutReach Newswire - 23 December 2024 - V-GREEN and PT Xanh…

15 hours ago