Positive Phase I results for a new solid dose prescription cannabidiol (CBD) demonstrate the tolerability and bioavailability of the drug.
Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex.
The trial met all pharmacokinetic objectives, so the company plans to progress the candidate into further clinical development and will meet with the US Food and Drug Administration (FDA) at a Pre-IND meeting in the first half of 2024.
Giles Moss, Chief Executive Officer of Sapient Therapeutics, commented: “The success of Part B of our Phase I 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.”
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.