TEL AVIV, Israel — CannaMore Biotechs, an Israel-based clinical-stage company focused on Cannabidiol (CBD) based treatments, completed its Phase 2a clinical trial evaluating the safety and efficacy of a CBD-based patent protected formulation for patients with Ulcerative Colitis (UC).
The trial is an open-label, single-arm study, aimed to assess the safety, tolerability, and efficacy of the CBD-based IP-based enema formulation, IcBD-01, as a potential treatment for UC. Conducted over a three-month period, the study included 10 patients who completed the trial, with promising results observed in the majority of participants.
Key highlights from the trial include:
- Primary Endpoint Achieved: A significant number of patients demonstrated a reduction in Mayo scores, indicating a decrease in disease severity.
- Patient-Reported Outcomes (PRO): Most participants reported substantial improvements in their symptoms, including reduced abdominal pain and better overall well-being.
- Safety and Tolerability: The formulation was well-tolerated with no significant side effects observed, confirming the safety profile of IcBD-01.
Prof. Timna Naftali, a specialist in gastroenterology at Meir Hospital in Kfar Saba, led the study, which was conducted at the Israeli medical facilities of leading Hospital Meir at Kfar Saba, Israel. Meir Hospital is one of the 14 full-scale hospitals of Clalit Health Services, the 2nd largest HMO in the world and CannaMore’s partner through Mor Research Applications TTO.
“The results of this trial are highly encouraging and support the potential of IcBD-01 as an effective treatment for Ulcerative Colitis,” said Prof. Naftali. “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.”
Based on these positive outcomes, CannaMore Biotechs plans to both advance to the next stage of clinical trials to further evaluate the long-term efficacy and safety of IcBD-01, while also exploring more immediate non-drug markets (such as medical Cannabis and others) sales in parallel to the drug R&D aimed for an FDA approval.
About CannaMore Biotechs Ltd.
CannaMore Biotechs Ltd. is a company dedicated to the simultaneous independent research and development of cannabinoid-based pharmaceutical drugs for various indications. Backed by a partnership with Mor Research Applications, the technology transfer company of Clalit Health Services, CannaMore leverages cutting-edge research to bring innovative treatments to patients in need. As a clinical research platform, CannaMore run multiple potential projects, with IcBD in colitis as the leading flagship, CannaMore is at the forefront of cannabinoid-based medical advancements.
