FDA Clears Lucid-MS Phase 2 Trial; Biogen MS Study and Bial PD Trial Reach Milestones

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Quantum Biopharma, giving the green light for a mid-stage clinical trial of Lucid-MS, a potential first-in-class oral therapy for multiple sclerosis (MS) that will be tested in people with MS for the first time. In other recent clinical trial milestones, Biogen's Phase 2 study of the oral drug BIIB091 in relapsing MS has reached completion, and Bial has concluded the treatment period in its Phase IIb ACTIVATE trial evaluating BIA 28-6156 in Parkinson's disease patients with a pathogenic GBA1 mutation.

Lucid-MS is designed to protect and repair myelin, the fatty sheath surrounding nerve fibers that is progressively damaged in MS. Rather than suppressing the immune system, it blocks a group of enzymes that alter myelin proteins in ways believed to make the sheath more vulnerable to autoimmune attacks, with the aim of preventing further demyelination and promoting myelin repair. According to Quantum, the IND submitted was approximately 15,000 pages long. 'This is not just a regulatory checkpoint — it is a breakthrough moment to try to demonstrate, possibly for the first time, that neuroprotection is achievable,' the company's founder and CEO said in a press release. The randomized, double-blind, placebo-controlled Phase 2 trial is intended to evaluate efficacy using clinical and radiological measures relevant to disability progression and disease biology, while also assessing safety and tolerability, according to the vice president of scientific and clinical affairs at Quantum. Preclinical studies in MS mouse models showed that Lucid-MS prevented myelin loss and promoted its repair, reduced symptom severity, and improved motor function. In Phase 1 studies involving healthy adults, the therapy was deemed safe and well tolerated. Trial start-up activities, including selection of study sites, are underway, with enrollment and dosing expected to begin as soon as possible. Quantum is working with Allucent, a global clinical research organization, to support the study's implementation.

Biogen's Phase 2 study of BIIB091, an oral drug designed to reduce disease activity in relapsing multiple sclerosis, has reached completion. The study, titled 'A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis,' tests BIIB091 alone and in combination with Biogen's existing therapy diroximel fumarate (DRF). The trial has two parts: in Part 1, participants receive either high-dose BIIB091, low-dose BIIB091, or standard-dose DRF; in Part 2, new participants receive either DRF alone or DRF plus BIIB091 at different dose levels. The study began enrolling after first submission on 23 March 2023. The status is now listed as completed, meaning patient visits and dosing are done, with primary completion occurring before the most recent update. The latest update to the record was submitted on 18 February 2026. No results are posted yet.

Bial has completed the treatment period in its Phase IIb ACTIVATE clinical trial evaluating BIA 28-6156 (pariceract) in Parkinson's disease patients with a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD). The 78-week, double-blind treatment period ended after all scheduled safety follow-ups, with data cleaning and analysis now in progress. Top line results from the Phase IIb trial are anticipated by the end of the second quarter. The study enrolled 273 genetically confirmed GBA-PD patients over 18 months across 85 clinical sites in 11 nations across North America and Europe. Strong patient retention was observed. BIA 28-6156 is being developed as an allosteric activator of beta-glucocerebrosidase (GCase) for the once-daily oral treatment of GBA-PD. 'Momentum is building across the Parkinson's scientific community around the clinical potential of pariceract,' Bial's clinical operations head and study lead said. The ACTIVATE study is designed to assess the safety, efficacy, pharmacodynamics, pharmacokinetics, and tolerability of BIA 28-6156 in GBA-PD patients.