MedPath

Lucid-MS

Generic Name
Lucid-MS

Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia

• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately. • The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026. • Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.

Quantum BioPharma's UnbuzzdTM Shows 40% Faster Alcohol Metabolism in Clinical Trial

• Clinical trial demonstrates UnbuzzdTM dietary supplement accelerates alcohol metabolism by 40% within 30 minutes compared to placebo, while improving alertness and stabilizing vital signs. • Study participants reported reduced mental fatigue and hangover symptoms without experiencing adverse side effects, marking a significant advancement in alcohol consumption management. • Quantum BioPharma maintains pharmaceutical development rights while partnering with Celly Nutrition for over-the-counter distribution, securing ongoing royalties up to $250 million.

Quantum BioPharma Advances Lucid-21-302 Clinical Trial for Multiple Sclerosis

• Quantum BioPharma's Lucid-21-302, a potential treatment for multiple sclerosis, has progressed to the second cohort dosing phase after positive safety review. • The Phase 1 trial evaluates the safety and pharmacokinetics of Lucid-21-302 in healthy adults, with dosing for the next group expected to begin shortly. • Quantum BioPharma's subsidiary, Lucid Psycheceuticals Inc., focuses on developing Lucid-MS to prevent and reverse myelin degradation in multiple sclerosis. • The company maintains a healthy current ratio of 3.76, indicating a strong ability to meet short-term obligations, and holds significant tax loss carry forwards.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

Phase 1 Trial of Lucid-MS Initiated to Protect Myelin Sheath in Multiple Sclerosis

• Quantum Biopharma's Lucid-21-302, a potential oral treatment for multiple sclerosis (MS), has entered a Phase 1 safety and tolerability trial in healthy adults. • The trial aims to assess the safety and pharmacological profile of Lucid-MS, with findings expected to inform the design of a Phase 2 clinical trial in MS patients. • Lucid-MS is designed to protect and potentially repair the myelin sheath, which is damaged in MS, without suppressing the immune system. • Preclinical studies in animal models of MS showed that Lucid-MS restored mobility following paralysis, suggesting potential for functional recovery.
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