- 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 US, 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 /PRNewswire/ – 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 MintzerMD, MBA, Brigid ReynoldsANP-BC, and the Alzheimer’s Clinical Trial Consortium (ACTC).The ACTC is led by Paul AisenMD, Alzheimer’s Therapeutic Research Institute at the USC, Ron PetersenMD, of Mayo Clinic, and Reisa SperlingMD 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 PidduckCEO, 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. [partnership] announced this morning provides further evidence that the Company has established processes that meet rigorous US 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.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.
In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment License from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing License for the extraction of natural cannabinoids. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.
(1) Reference: Alzheimer’s Disease Facts and Figures, 2022 Annual Report, Alzheimer’s Association
Reference: Gerlach LB, Fashaw S, Strominger J, Ogarek J, Zullo AR, Daiello LA, Teno J, Shireman TI, Bynum JPW. Trends in antipsychotic prescribing among long-term care residents receiving hospice care. J Am Geriatr Soc. 2021 Aug;69(8):2152-2162.
(2) Reference: Liu CS, Chau SA, Ruthirakuhan M, Lanctôt KL, Herrmann N. Cannabinoids for the Treatment of Agitation and Aggression in Alzheimer’s Disease. CNS Drugs. 2015 Aug;29(8):615-23.
Reference: Ruthirakuhan M, Lanctôt KL, Vieira D, Herrmann N. Natural and Synthetic Cannabinoids for Agitation and Aggression in Alzheimer’s Disease: A Meta-Analysis. J Clin Psychiatry. 2019 Jan 29;80(2):18r12617.
Alzheimer’s Clinical Trials Consortium (ACTC) is funded by a Cooperative Agreement from the National Institute on Aging, National Institutes of Health. Cooperative Agreement number U24AG057437.
Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY)
Duration: 4 years
NIA/NIH Grant #: R01 AG068324-01
Cautionary Note Regarding Forward-Looking Information:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected” , “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions , events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, statements regarding: exciting opportunities ahead; the expected results of any clinical research, the development of future cannabis derived pharmaceutical drugs, being a low-capital avenue to research and future marketable pharmaceutical products, and targeting further similar projects. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.
SOURCE MediPharm Labs Corp.