MMJ International Holdings Receives FDA Orphan Drug Designation for MMJ-002 in Huntington’s Disease

VCBeat (WeChat Official Account: vcbeat) has learned that MMJ International Holdings, a leading medical cannabis research company, announced on January 29 (local time) that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation to MMJ-002, a drug independently developed by the company. MMJ-002 is one of MMJ International Holdings’ key pipeline candidates and is intended for the treatment of Huntington’s disease.

MMJ International Holdings, a privately held enterprise established in 2015, operates in both the United States and Jamaica. The company collaborates with leading cannabinoid scientists worldwide to continue exploring the therapeutic potential of a range of novel cannabinoids and other plant-derived molecules across various treatment areas.

Since 2015, MMJ International Holdings has been legally advancing the science of medical cannabis through patient clinical trials and research. This latest Orphan Drug designation aligns with MMJ’s mission to do everything possible to improve patients’ lives.

The fact that the FDA has granted an Orphan Drug Designation to MMJ International Holdings demonstrates that the company can bring hope for the diagnosis and treatment of rare diseases or conditions. As a developer of drugs with Orphan Drug Designation, MMJ International Holdings is eligible for various development incentives associated with such designation, including tax credits for qualified clinical trials.

As stated by Duane Boise, CEO of MMJ International Holdings: “The Orphan Drug Award marks another milestone in our ongoing effort to set industry standards. Leveraging its mature drug discovery and development processes, intellectual property portfolio, and regulatory and manufacturing expertise, MMJ International Holdings has established a leading position in the development of plant-derived cannabinoid therapies.”

Duane Boise further added, “The Phase II clinical trial of MMJ International Holdings’ program will demonstrate that this therapy can slow or halt the detrimental effects of Huntington’s disease on patients, thereby improving the lives of those affected by Huntington’s disease.”

Huntington’s disease is a hereditary disorder that causes degeneration of neuronal cells in the brain. This condition significantly impairs bodily functions, typically leading to motor and cognitive deficits. Its hallmark features include choreiform movements accompanied by progressive cognitive and psychiatric dysfunction, ultimately resulting in dementia. The underlying cause is the aberrant expression of expanded CAG trinucleotide repeats in the huntingtin gene, which disrupts various molecular pathways and eventually leads to neuronal dysfunction and degeneration.

Dr. Elio Mariani, R&D Director at MMJ, explained: “MMJ has two in-house developed cannabis-based pharmaceuticals. The lead candidate, MMJ-001, is a patented molecule derived from cannabidiol (CBD) and is currently being developed for the treatment of multiple sclerosis and Huntington’s disease. The company plans to initiate a Phase II clinical trial in humans for the development of MMJ-002 in early 2019.”

(Compiled by Liao Min)