Israeli biopharmaceutical company CannaMore Biotechs has concluded a Phase IIa clinical trial of IcBD-01, a cannabidiol (CBD) based treatment for ulcerative colitis (UC).
The open-label, single-arm trial evaluated the safety and efficacy of the patent-protected enema formulation in patients with UC.
Go deeper with GlobalData
The study took place at the medical facilities of Meir Hospital in Kfar Saba, Israel, which is owned by CannaMore’s partner company Clalit Health Services.
A total of ten patients were enrolled in the trial, which took place over three months.
The trial met its primary endpoint with a significant number of subjects demonstrating a reduction in Mayo scores, indicating reduced disease severity.
Most subjects reported improvements in symptoms, including a decline in abdominal pain and improved overall well-being.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe CBD-based treatment was found to be well-tolerated without any significant side effects, confirming its safety profile.
Following these results, CannaMore Biotechs plans to carry out further clinical trials to assess the drug’s long-term efficacy and safety.
The company is also considering immediate non-drug market sales while continuing drug research and development (R&D) for obtaining US Food and Drug Administration approval.
Meir Hospital gastroenterology specialist and study lead Professor Timna Naftali said: “The results of this trial are highly encouraging and support the potential of IcBD-01 as an effective treatment for ulcerative colitis.
“We observed significant improvements in both clinical outcomes and patient-reported symptoms, which marks a promising step forward in our ongoing efforts to develop innovative CBD-based therapies.
“This treatment may provide a safe and effective solution for the subgroup of patients with ulcerative proctitis, where there is an unmet need for effective and safe treatment.”
Earlier this year, Johnson and Johnson announced positive results from its Phase III trial of Tremfya (guselkumab), a maintenance therapy designed to treat moderate to severe UC.
