MediciNova | MedPath

First Patient Enrolled in NIH-Funded Expanded Access Program for MN-166 in Advanced ALS

a month ago

• MediciNova has enrolled the first patient in an NIH-funded Expanded Access Program trial evaluating MN-166 (ibudilast) in approximately 200 ALS patients who are ineligible for the ongoing Phase 2/3 COMBAT-ALS trial. • The EAP trial, supported through the Act for ALS, aims to provide access to MN-166 for individuals with advanced stages of amyotrophic lateral sclerosis while evaluating the drug's safety and efficacy. • MN-166 is an oral small molecule that inhibits phosphodiesterase type-4 and inflammatory cytokines, holding Orphan Drug Designation and Fast Track status from the FDA for ALS treatment.

Pipeline Advances in Head and Neck Cancer Treatment: Over 100 Drugs in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 80 companies developing 100+ drug candidates for head and neck cancer, highlighting significant research momentum in this therapeutic area. • Key late-stage candidates include Debiopharm/Merck's xevinapant, GlaxoSmithKline's dostarlimab, and QBiotics' tigilanol tiglate, each employing novel mechanisms to potentially improve outcomes for patients with limited treatment options. • Multiple clinical trials are underway testing innovative approaches including IAP inhibitors, immune checkpoint blockers, and oncolytic therapies, with several Phase III studies expected to deliver results that could reshape treatment paradigms.

MediciNova's Ibudilast Shows Promise in ALS Trial: Interim Analysis Reveals Strong Correlations

6 months ago

• MediciNova's COMBAT-ALS Phase 2/3 trial of MN-166 (ibudilast) in ALS shows positive correlations between 6-month and 12-month data for key metrics. • The Data Safety Monitoring Board (DSMB) recommended the trial continue as planned, supporting the robustness of the study design. • Patient assignments are expected to be completed by June 2025, with trial results anticipated in 2026, offering hope for ALS treatment advancements. • MediciNova is supporting continued treatment through the FDA's Expanded Access Program, ensuring access to MN-166 for more ALS patients.

Ibudilast Expanded Access Program for ALS Patients Managed by Widetrial

6 months ago

• Widetrial will manage the physician network for an expanded access program (EAP) providing ibudilast (MN-166) to ALS patients ineligible for clinical trials. • The EAP, funded by a $22 million federal grant to the Mayo Clinic, aims to enroll 200 ALS patients across multiple U.S. sites. • Ibudilast, designed to reduce immune cell activity and neuroinflammation, showed potential in a Phase 2 trial when added to riluzole. • The EAP study will measure ibudilast's impact on disease progression and neurofilament light chain (NfL) levels over six months.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

6 months ago

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• 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.

MediciNova's Ibudilast (MN-166) Shows Promise in ALS Treatment: Phase 2/3 Trial Update

8 months ago

• MediciNova presented an update on its Phase 2/3 COMBAT-ALS trial of MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS) at the 2024 Annual NEALS Meeting. • The presentation highlighted the study design, scientific rationale, objectives, inclusion criteria, and enrollment status of the ongoing trial as of October 18, 2024. • An NIH-funded Expanded Access Protocol (EAP) is underway to provide MN-166 (ibudilast) to ALS patients ineligible for the COMBAT-ALS trial, supported by a $22 million grant. • MN-166 (ibudilast) is a small molecule compound targeting PDE4 and inflammatory cytokines, with potential benefits for neurodegenerative diseases like ALS.

FDA Approves Rezdiffra (Resmetirom) as First Treatment for NASH with Liver Fibrosis

a year ago

• The FDA has granted accelerated approval to Rezdiffra (resmetirom) for adults with noncirrhotic NASH and moderate to advanced liver fibrosis. • Rezdiffra, a THR-β agonist, is the first FDA-approved medication for NASH, also known as MASH, marking a significant milestone. • Approval was based on Phase 3 MAESTRO-NASH trial data, which demonstrated improved liver fibrosis and NASH resolution compared to placebo. • Madrigal plans to launch Rezdiffra in the U.S. in April, with a patient support program to aid access and affordability.