MMJ BioPharma Cultivation is completing its Cannabis DEA bulk manufacturing license process, a seven-year DEA battle that has delayed the company's ability to supply its FDA trials. Once approved, MMJ will begin GMP manufacturing of its softgel capsules for large scale clinical testing in Huntington's disease and Multiple Sclerosis.
WASHINGTON, DC / ACCESS Newswire / September 25, 2025 / New Huntington's Breakthrough Highlights Urgent Need for Scalable, Accessible Treatments: MMJ BioPharma's Cannabis Derived Softgel Capsules Offer Safer Path Forward
The global Huntington's disease community is celebrating encouraging trial results from a University College London study using cutting edge gene therapy to silence the mutant Huntington's gene. While this represents a historic advance in neurosurgical research, it also underscores the critical need for scalable, less invasive therapies that can reach the tens of thousands of patients who cannot undergo experimental brain surgery.
MMJ BioPharma Cultivation, a subsidiary of MMJ International Holdings, is advancing an alternative approach: pharmaceutical-grade cannabinoid soft gelatin capsules (MMJ-001 and MMJ-002) designed for FDA-regulated clinical trials in Huntington's disease and Multiple Sclerosis.These capsules have already received FDA Orphan Drug Designation and Investigational New Drug (IND) status, positioning them as among the first oral cannabis derived medicines tailored for neurodegenerative diseases.
A Tale of Two Approaches
Gene Therapy at UCL: Involves 12-18 hours of neurosurgery, direct infusion of viral vectors into deep brain regions, and long recovery times. Results show promising slowing of disease progression, but risks include brain inflammation, high cost, and limited availability.
MMJ Softgel Capsules: Non-invasive, taken orally, manufactured under Good Manufacturing Practice (GMP)standards, and scalable for global distribution. Early clinical data suggests cannabinoid therapies can reduce neuro inflammation, protect neurons, and ease motor and cognitive symptoms without requiring experimental surgery.
"We applaud the bravery of families participating in this historic gene therapy study," said Duane Boise, CEO of MMJ International Holdings. "But the reality is that most Huntington's patients will never undergo brain surgery in specialized centers. That is why MMJ's mission is so important-we are building safe, pharmaceutical-grade oral medicines that can be prescribed and distributed to patients everywhere."
The Human Urgency
Huntington's disease affects approximately 75,000 people in the US, UK, and Europe, with hundreds of thousands carrying the genetic mutation that guarantees they will eventually develop symptoms. Current treatment options are limited to symptom management, with no widely available therapies proven to slow progression.
Jack May-Davis, a 30-year-old barrister's clerk from the UK who inherited the gene from his late father, described the UCL therapy news as "absolutely incredible." Yet even he acknowledged the challenge: the therapy requires invasive neurosurgery and will come with extraordinary costs.
For families like Jack's, MMJ's capsule-based approach could represent a more practical lifeline-something their doctors can prescribe in familiar form, through regular pharmacies, without specialized surgery.
Looking Ahead
MMJ BioPharma Cultivation continues its seven-year regulatory journey with the U.S. Drug Enforcement Administration (DEA) to obtain a bulk manufacturing license for cannabis-derived active pharmaceutical ingredients. Once complete, MMJ will begin large-scale GMP manufacturing for its FDA clinical trials in Huntington's disease and Multiple Sclerosis.
"This is not an either-or choice," Boise added. "Gene therapy may eventually transform the landscape for a small number of patients. But MMJ's capsules represent the scalable, safer solution that can bring hope to the entire Huntington's community today."
About MMJ International Holdings
MMJ International Holdings is a pioneering biopharmaceutical company developing cannabis-derived, FDA-regulated softgel capsule medicines for rare and chronic neurological diseases. Its lead candidates, MMJ-001 (Multiple Sclerosis)and MMJ-002 (Huntington's disease), have both received FDA Orphan Drug Designation. MMJ is dedicated to advancing science, patient care, and global access to safe cannabinoid pharmaceuticals.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmjs-fda-cannabis-softgel-capsule-could-be-the-real-game-changer-for-1078205
