The University of California San Francisco (UCSF) is teaming up with Nektar Therapeutics to study the potential of NKTR-0165, an experimental antibody that activates the tumor necrosis factor receptor type 2 (TNFR2), to treat multiple sclerosis (MS). UCSF neurologist Stephen L. Hauser,…
Experimental treatment
Bionxt Solutions’ experimental sublingual therapy BNT23001 led to about 40% higher blood exposure to cladribine than a conventional oral tablet formulation, such as those used in multiple sclerosis (MS) therapies like Mavenclad, the company reported. The results come from a preclinical study in adult miniature pigs,…
Brenig Therapeutics has launched an early Phase 1 clinical trial to evaluate its experimental small molecule BT-409 in healthy volunteers. The therapy is being developed for people with multiple sclerosis (MS) and other chronic neurologic conditions. It is aimed at blocking inflammatory responses by targeting the NLRP3 inflammasome,…
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…
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…
After months of delay, the U.S. Food and Drug Administration (FDA) has rejected Sanofi‘s application seeking approval of tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (MS). While Sanofi announced earlier this month that the decision was likely to be delayed again…
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 first patient has been dosed in a Phase 1 clinical trial of Autolus Therapeutics‘ experimental CAR T-cell therapy, obecabtagene autoleucel (obe-cel), in people with progressive forms of multiple sclerosis (MS) who have failed to respond to existing treatments. Dosing took place at University College London Hospitals NHS…
Liberate Bio’s CAR-M cell therapy almost completely depleted B-cells in nonhuman primates, suggesting the approach may be used to treat B-cell diseases such as multiple sclerosis (MS) and some cancers. The therapy is designed to genetically engineer monocytes and macrophages, two types of immune cells, to target and…
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…
Treatment with equecabtagene autoleucel, known for short as eque-cel — Iaso Biotherapeutics‘ CAR T-cell therapy candidate for people with progressive forms of multiple sclerosis (MS) — was well tolerated and led to an easing of disability for five patients taking part in a Phase 1 clinical trial. The…
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…
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…
Treatment with masitinib, an experimental therapy being developed by AB Science for progressive forms of multiple sclerosis (MS), reduced markers of nerve damage and inflammation and slowed disease progression in a mouse model of MS. “This study is the first to demonstrate that masitinib can lower serum NfL…
Vidofludimus calcium, an experimental oral therapy from Immunic Therapeutics, reduced the risk of confirmed disability worsening and slowed brain shrinkage in people with progressive forms of multiple sclerosis (MS). That’s according to top-line data from CALLIPER (NCT05054140), a Phase 2 clinical trial testing a daily dose of…
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…
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…
OCS-05, an experimental medication that Oculis is developing to treat acute optic neuritis, a common symptom of multiple sclerosis (MS) that can lead to vision loss, was well tolerated and improved measures of vision and eye health in a Phase 2 clinical trial. The ACUITY study (NCT04762017) included…
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…
LPX-TI641, Lapix Therapeutics‘ experimental oral therapy to restore immune system balance in people with multiple sclerosis (MS) and other autoimmune diseases, was found safe and well tolerated at all doses tested in healthy adults. That’s according to top-line data from a Phase 1 trial (NCT05853835), which…
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…