FDA puts clinical hold on planned Phase 2 trial of Lucid-MS
Quantum says it will work with agency to address issues raised
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- The FDA placed a clinical hold on Quantum Biopharma's planned Phase 2 trial for Lucid-MS.
- The FDA requested further information and clarifications before allowing the trial to proceed.
- Lucid-MS aims to protect myelin by inhibiting enzymes, with promising results in early studies.
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Quantum Biopharma’s application seeking clearance to begin a Phase 2 trial testing Lucid-MS in people with multiple sclerosis (MS).
Quantum said the FDA requested further information before clearing the investigational new drug (IND) application and allowing the study to proceed. The company didn’t disclose the agency’s specific concerns.
“We are committed to working constructively with the FDA to address the comments raised and to advancing Lucid-MS responsibly for people living with MS,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of clinical and scientific affairs, said in a company press release. “We believe the matters identified by the FDA are fully addressable and intend to work collaboratively with the agency to resolve the comments raised in the clinical hold letter.”
The clinical hold comes about two months after Quantum submitted the IND seeking FDA clearance for the Phase 2 trial to evaluate the treatment’s safety and tolerability in people with MS, while exploring its potential to slow disease progression.
As a result of the FDA’s decision, Quantum has withdrawn previously announced timelines for regulatory review, trial initiation, and interim data reporting, noting that future development plans will depend on ongoing regulatory interactions. The company said it is working with advisors and development partners, and plans to submit a formal response package after reviewing the FDA’s comments and completing related activities.
Enzyme-targeting therapy has shown promise in studies
Lucid-MS is an oral therapy designed to protect myelin, the fatty coating that surrounds nerve fibers and helps them transmit electrical signals. In MS, damage to this sheath in the brain and spinal cord disrupts communication between nerve cells, contributing to symptoms and disease progression.
Unlike approved disease-modifying therapies, which mainly work by reducing the immune responses that drive myelin damage, Lucid-MS is intended to protect myelin directly and potentially promote its repair.
The therapy targets a family of enzymes that become overactive in MS and are thought to make myelin more vulnerable to autoimmune attacks. By inhibiting their activity, Lucid-MS is designed to prevent myelin damage, which is expected to slow disease progression and potentially restore lost functions.
The therapy has shown encouraging results in mouse models of MS, in which treatment reduced disease severity and improved motor function to levels comparable to those of healthy animals. Lucid-MS has also been deemed safe and well tolerated at single and multiple doses in two Phase 1 studies involving healthy volunteers.
To support its IND application, Quantum also completed two toxicology studies requested by the FDA, including a 90-day oral toxicity study and a toxicokinetic study, which examines how a therapy is absorbed, distributed, metabolized, and eliminated by the body. While the company included the findings in its regulatory submission, it did not disclose detailed results.
Winifred Doody
In your estimate how long do you feel it will take for Quantum to submit information required by the FDA and then how long before Quantum could continue with Phase 2 trial for Lucid-MS ?
Peggy Ianniello
Why is the FDA refusing the trial 2 for Lucid-MS??? I just finished listening to the speil of Dr. Oz's miracle NeuroSalt which noted it rebuilds the myelin coating on nerves. Seems real fishy to me that what Lucid-MS is offering MS patients would be life-changing, speaking as a MS patient myself!! I would totally join a trial 2 level if the FDA would approve such a trial.
Kate
Thank you for reporting this! I had taken Humira for Crohn's Disease before, but was taken off it due to sudden progressive MS symptoms. My first Neurologist was VERY kind & good but the Parking Fees outside VGH Hospital in Vancouver Canada were too expensive and to wait to see the Doctor took hours. I then went to 2 other Neurlogists in North Vancouver and one was very pregnant and preoccupied, so then I went to another older Neurologist that told me, "I cannot do anything for your Progressive MS and to get OUT of her Office!" She was just SO CRUEL that I have not been back to see any Neurologist since! That happened about 11 years ago.
I am looking to get my life back for my left side no longer works very well. And I am Certainly NOT looking for any foolish " Immune Dumbing Down Drug" either, for I've already suffered from various Infections with those! I view the Drug Companies that produce Immune Dumbing Down Drugs as money making Corrupt folk because they never do seek to get to the Root causes of the Problem. Their Biological Drug only guarantees them repeat Customers for life. That is just NOT GOOD ENOUGH FOR PATIENTS! Patients want REAL CURES & REAL PROGRESS so they are able to get their lives back which are presently being very much Wasted! Thank you for bothering to read this! Sincerely, Kate H
George Siegel
Mice are not human b
Mice are not humans.
Carol Lanzoni
Nothing That I used so far worked except the intravenous medication I used from Germany that wasn't FDA approved that Dr Nieper made.