MMJ International Holdings, the premier medical cannabis research company, announced that is has filed an application with the FDA for “Orphan Drug Designation” for its drug which will be used for the treatment of Huntington’s Disease. The drug, MMJ-002 is one of MMJ’s lead drugs and the company is confident that it will bring much needed relief to patients suffering from the debilitating effects of Huntington’s Disease.
Since 2015, MMJ has been advancing the science of medical marijuana legally through patient clinical trials and research. This latest application for Orphan Drug Designation is in keeping with MMJ’s mission to do everything possible to improve the lives of patients.
If an approval is granted Orphan Drug status by the FDA it means that is has demonstrated promise for the diagnosis and/or treatment of rare diseases or conditions. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing.
As stated by MMJ’s CEO, Duane Boise, “MMJ’s Orphan Drug application is another milestone for the company as we continue to set industry standards. MMJ has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise”.
Mr. Boise added, “However, with this Orphan Drug application, the most significant benefit is to the patients with Huntington’s disease since our development process can be advanced quickly. MMJ’s Planned phase II clinical trial for this program will demonstrate the ability of this therapy to slow or stop the deleterious effects of Huntington’s chorea”
Huntington’s disease is an inherited disease that causes the progressive breakdown (degeneration) of nerve cells in the brain. The disease has a broad impact on a person’s functional abilities and usually results in movement and cognitive disorders.
Dr. Elio Mariani, MMJ’s Director of Research and Development explained, “MMJ has two proprietary cannabinoid pharmaceutical drugs in development. The lead product candidate, MMJ-001, is a patented molecule derived from cannabidiol (CBD) and is being developed for the treatment of multiple sclerosis and Huntington’s disease. The company plans to initiate a Phase II human clinical study in early 2019.”
According to Dr. Mariani, “we are working diligently to address the significant unmet medical need in people suffering from this deadly disease and this designation furthers our mission to develop impactful cannabinoid-derived medicines to improve clinical outcomes for patients with Huntington’s disease.”
About MMJ International Holdings Corp:
MMJ International Holdings Corp was founded in 2015 and is privately owned. The company has operations in the United States and Jamaica. Working with leading cannabinoid scientists around the world, MMJ is continuing to explore the potential of a range of novel cannabinoid and other botanical molecules in a number of distinct therapeutic areas.
Media queries in the US, please contact:
Ann Marie Ganness
In Jamaica: Michael Sharpe