- MediPharm to design, manufacture and supply a liquid oral cannabis study drug for the Phase 2 Life’s end Benefits of cannabidiol and tetrahydrocannabinol (LiBBY) study, to be conducted in the U.S., across 20 sites.
- The lead investigators have been awarded a total of US$16M grant from the US National Institutes of Health and the National Institute on Aging to support the research project.
BARRIE, ON, Aug. 9, 2022 /CNW/ – MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has entered into a research support agreement with the Keck School of Medicine of University of Southern California (USC) to conduct a randomized double-blind placebo controlled Phase 2 trial on the efficacy of THC and CBD to treat hospice-eligible patients diagnosed with dementia and experiencing agitation.
The lead investigators are Jacobo Mintzer, MD, MBA, Brigid Reynolds, ANP-BC, and the Alzheimer’s Clinical Trial Consortium (ACTC).The ACTC is led by Paul Aisen, MD, Alzheimer’s Therapeutic Research Institute at the USC, Ron Petersen, MD, of Mayo Clinic, and Reisa Sperling, MD of the Brigham and Women’s Hospital at Harvard Medical School. Consistent with MediPharm’s commitment to clinical research and the progression and adoption of drugs containing cannabis, the Company will supply the Sponsor and the Principal Investigators with the study drug and placebo, and such other information and assistance as may be required during the course of the study.
David Pidduck, CEO, MediPharm Labs commented, “We are proud to participate in this important research that further solidifies our pharmaceutical approach to medical cannabis. This trial benefits from passionate lead investigators, a world-renowned sponsor institution and funding from the US National Institute of Health. Dementia and related indications are hard to treat for patients and caregivers especially at the end-of-life stage. It is our hope that the study will potentially provide a better therapeutic option than the current standard of care. MediPharm has invested in the infrastructure, licensing and expertise to become the preferred partner for pharmaceutical companies looking to add drugs containing cannabis to their pipelines. The [partnership] announced this morning provides further evidence that the Company has established processes that meet rigorous U.S. national and state specific regulations, and set the foundation for similar announcements in the future as we continue to build our pipeline.”
Study Details – provided by Alzheimer’s Clinical Trial Consortium
Approximately 50% of people diagnosed with Alzheimer’s disease or other types of dementia will receive hospice care at the end of their life(1). Of these, more than 70% will be prescribed psychiatric medications for management of agitation(2). There are no approved treatments or guidelines to assist clinicians in addressing end-of-life agitation in dementia. In the absence of appropriate evidence-based guidelines, patients are typically prescribed a combination of antipsychotics, sedatives, and opiates. These medications often lead to undesirable side effects, all of which tend to make the situation even worse, lowering quality of life for patients, and adding burden to their care partners.
Recent research suggests that derivatives of cannabis can be beneficial in controlling agitation and distress without the side effects of medications commonly used to treat agitation. In this project, Keck School of Medicine has chosen to use a combination of two medications, THC and CBD. This project aims to test the efficacy of an oral combination of THC and CBD, for the treatment of agitation in participants with a diagnosis of dementia who are eligible for hospice and experiencing agitation. The proposed study consists of a 12-week, Phase 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, with primary outcomes evaluating the efficacy and tolerability of a THC/CBD oral combination at week 2 and secondary outcomes at week 12.
The study will recruit approximately 150 participants from 20 clinical trial sites in the United States over a two year period.