The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to privosegtor, an experimental treatment from Oculis that aims to protect the vision of people experiencing acute optic neuritis. This condition, which involves inflammation of the optic nerve, is a common and often debilitating symptom of…
Experimental treatment
Quantum Biopharma has completed dosing in two toxicology studies requested by the U.S. Food and Drug Administration (FDA) that aim to support the launch of clinical studies of Lucid-MS, an experimental treatment for multiple sclerosis (MS) that’s designed to slow myelin loss. The 180-day toxicity and toxicokinetic…
Immutep’s experimental immunotherapy, IMP761, continues to demonstrate a favorable safety profile, along with sustained suppression of T-cell activity, immune cells that are overly active in multiple sclerosis (MS) and other autoimmune diseases. These findings are based on data from healthy people enrolled in an ongoing first-in-human Phase 1…
Following negative Phase 3 trial results, Sanofi announced that it will not be pursuing approval of its experimental therapy tolebrutinib for primary progressive multiple sclerosis (PPMS). Meanwhile, a decision from the U.S. Food and Drug Administration (FDA) on tolebrutinib’s use in nonrelapsing secondary progressive MS (SPMS) is likely…
A Phase 2 clinical trial testing PIPE-307, an experimental therapy designed to support myelin repair in people with multiple sclerosis (MS), has failed to meet its primary or secondary efficacy goals. The U.S.-based VISTA trial (NCT06083753) enrolled more than 180 adults with relapsing-remitting MS (RRMS). Participants received…
SUDO-550, an oral TYK2 inhibitor being developed by Sudo Biosciences, was found to be safe, well-tolerated, and to fully reach the brain in a first-in-human clinical trial involving healthy volunteers, according to clinical trial results. The Phase 1 clinical trial, which began dosing late last year, also showed…
Metis Biotech‘s experimental oral therapy MTS-004 was safe and eased symptoms of pseudobulbar affect (PBA), a neurological condition marked by bouts of sudden, involuntary, and inappropriate laughter or crying, in people with multiple sclerosis (MS) and other neurological disorders. That’s according to data from a Phase 3 clinical…
The U.S. Food and Drug Administration (FDA) has given Tr1x the green light to launch a first-in-human clinical trial of TRX319, a cell therapy candidate designed to restore immune balance in people with progressive forms of multiple sclerosis (MS). With FDA clearance now granted for its investigational new…
Researchers have identified two experimental medications that may promote myelin repair in people with multiple sclerosis (MS). The two compounds have shown promise in cell and animal models, and preclinical work is ongoing to bring them into clinical testing. The compounds were identified by academic researchers, but the program…
Quantum Biopharma says it is closer to initiating a Phase 2 clinical trial — one involving people living with multiple sclerosis (MS) — to test its experimental therapy Lucid-MS after receiving the final reports from two toxicology studies requested by the U.S Food and Drug Administration (FDA). The…
Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium continues to show a significant effect on disability worsening in people with progressive forms of multiple sclerosis (MS), even in those without signs of active inflammation in the brain, a group with limited treatment options. That’s according to new data…
A person with multiple sclerosis (MS) has for the first time been treated with an “off-the-shelf” CAR T-cell therapy called azercabtagene zapreleucel (azer-cel), a donor-derived approach that’s never before been tested in the disease. The experimental treatment was given at Nebraska Medicine’s Fred & Pamela Buffett Cancer Center…
More than 90% of relapsing-remitting multiple sclerosis (RRMS) patients who received Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium have not experienced confirmed disability worsening after nearly three years. That’s according to new data from the EMPhASIS Phase 2 clinical trial (NCT03846219) and its open-label extension (OLE)…
An experimental medicine, 2-D08, boosts motor function in mice and primate models of multiple sclerosis (MS) by repairing the myelin sheath, the protective coating on nerve fibers that’s damaged in people with the neurodegenerative condition, a study showed. 2-D08 also outperformed the approved therapy dalfampridine, sold as Ampyra…
Ambio Life Sciences has launched a clinical program to test ibogaine — an experimental, naturally occurring psychedelic — for neurodegenerative conditions such as multiple sclerosis (MS). The program aims to offer therapeutic support in a safe, medically supervised setting. Now open to the public following a soft launch…
Quantum Biopharma has signed an agreement with a global pharmaceutical contract research organization to continue advancing Lucid-21-302, its experimental therapy for promoting myelin repair with multiple sclerosis (MS). The collaboration will help the company put together an investigational new drug (IND) application for the therapy, which is also…
Frexalimab, an experimental antibody-based medication, was well tolerated and maintained disease control over two years in adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from an open-label extension to a Phase 2 clinical trial (NCT04879628) in which frexalimab outperformed a placebo at reducing…
Fibrobiologics’ investigational cell therapy CYMS101 can significantly increase myelin production and promote myelin repair in a mouse model of multiple sclerosis (MS), the company has announced. The experimental therapy, which is made of connective tissue cells called fibroblasts, demonstrated benefits within seven weeks after both single and multiple infusions…
In a new deal, TG Therapeutics will use MaxCyte’s engineering technology to develop and manufacture its off-the-shelf CAR T-cell therapy candidate azercabtagene zapreleucel — azer-cel for short — for adults with progressive forms of multiple sclerosis (MS). The experimental treatment is being advanced toward a Phase 1…
IMP761, an experimental immunotherapy Immutep is developing for multiple sclerosis (MS) and other autoimmune conditions, has shown a promising safety profile in an ongoing Phase 1 clinical trial in healthy volunteers, with no treatment-related side effects reported to date, the company said. The first-in-human Phase 1 trial…
The U.S. Food and Drug Administration (FDA) has given the green light to Immpact Bio to conduct a Phase 1 clinical trial to test IMPT-514, its experimental cell therapy, in people with multiple sclerosis (MS). With the investigational new drug (IND) clearance by the FDA, Immpact Bio now…
Abata Therapeutics has received an investment from Bristol Myers Squibb to support the development of its experimental regulatory T-cell (Treg) therapies for severe autoimmune and inflammatory diseases, including progressive multiple sclerosis (MS). The new equity investment from the global biopharmaceutical company follows last week’s green light from…
A Phase 1 clinical trial that’s testing IMP761, an experimental treatment for multiple sclerosis (MS) and other autoimmune conditions, has dosed its first healthy participant, the therapy’s developer has announced. Immutep received regulatory clearance to start the first-in-human trial of IMP761 in the Netherlands about a…
PIPE-307, an experimental oral therapy that’s currently in Phase 2 testing for relapsing-remitting multiple sclerosis (RRMS), was shown to promote myelin repair in a mouse model of multiple sclerosis (MS). The preclinical findings were published in PNAS, in the study “Targeting the muscarinic M1 receptor…
Iaso Biotherapeutics has received the green light from the U.S. Food and Drug Administration (FDA) to start clinical trials of its investigational CAR T-cell therapy equecabtagene autoleucel (eque-cel) in people with multiple sclerosis (MS). The FDA’s clearance of the company’s investigational new drug (IND) application makes MS the…
Immutep has been cleared to start a Phase 1 clinical trial in the Netherlands to test IMP761, its experimental antibody therapy for autoimmune diseases such as multiple sclerosis (MS), in healthy volunteers. The first-in-human Phase 1 clinical trial seeks to assess the safety and pharmacological properties of IMP761.
Abata Therapeutics is expected to launch a Phase 1 clinical trial by the end of the year to test ABA-101, its experimental therapy for progressive multiple sclerosis (MS), after getting a green light from the U.S. Food and Drug Administration (FDA). The FDA approved Abata’s investigational new drug…
Convelo Therapeutics is developing two experimental oral treatments to promote myelin repair in multiple sclerosis (MS) and both have shown promise in preclinical models. The company is in the final stages of safety studies in large animals. Once those studies are done, it plans to start studies that…
Kyverna Therapeutics has developed a method that enables KYV-101, an experimental CAR T-cell therapy for multiple sclerosis (MS) and other conditions, to be produced in a much shorter timeframe than conventional manufacturing processes, a study shows. The approach took less than three…
Monte Rosa Therapeutics is planning to initiate a Phase 1 clinical trial to test MRT-6160, its investigational therapy for multiple sclerosis (MS) and other autoimmune diseases, by mid-2024. The trial will follow the submission of an investigational new drug (IND) application, a formal request to U.S. regulatory authorities…