phase 2 clinical trial

A mesenchymal stem cell therapy led to significant improvements in quality-of-life scores for people with multiple sclerosis (MS) in a small clinical trial, according to the treatment’s developer Hope Biosciences Research Foundation (HBRF). “The results of this trial are groundbreaking for multiple sclerosis,” Donna Chang, president of HBRF,…

Sanofi has ended a Phase 2 clinical trial into oditrasertib, an investigational RIPK1 inhibitor therapy, in people with relapsing and progressive multiple sclerosis (MS) after it failed to meet its goals. The study, which had started dosing early last year, failed to show that oditrasertib significantly lowered…

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…

Nearly one year of treatment with frexalimab, an antibody being developed by Sanofi, significantly reduced the blood levels of neurofilament light chain (NfL), a biomarker of nerve cell damage that typically is elevated in people with multiple sclerosis (MS). That’s according to new data from a company-sponsored…

The Polish biotechnology company PolTREG plans to launch Phase 2 trials testing its Tregs therapy — the T-cell-based treatment PTG-007 — in people with multiple sclerosis (MS) in Poland later this year. The biotech company has earned a Current Good Manufacturing Practice (CGMP) certification for its new manufacturing…

The U.S. Food and Drug Administration (FDA) has cleared a Phase 2 clinical trial to test Kyverna Therapeutics‘ cell-based therapy candidate KYV-101 in people with treatment-resistant progressive multiple sclerosis (MS). Called KYSA-7 (NCT06138132), the open-label trial will enroll an estimated 12 patients with either primary progressive…

A global Phase 2 clinical trial investigating the oral therapy vidofludimus calcium (IMU-838) in people with progressive forms of multiple sclerosis (MS) has reached full enrollment, the treatment’s developer, Immunic Therapeutics, reports. Called CALLIPER (NCT05054140), the trial is assessing whether the neuroprotective effects of vidofludimus calcium seen in…

About 2.5 years of treatment with tolebrutinib was associated with low relapse rates and stable disability levels among people with relapsing forms of multiple sclerosis (MS), according to data in an ongoing, open-label extension of a Phase 2b trial. The oral treatment also continued to show a “favorable”…

A Phase 2 clinical trial evaluating whether a low dose of ketamine can ease fatigue in people with multiple sclerosis (MS) is enrolling patients at Johns Hopkins University in Baltimore. The study, called INKLING-MS (NCT05378100), is recruiting up to 110 patients, ages 18-65, who have been complaining of fatigue as…

Patient dosing has begun in a Phase 2 trial testing Denali Therapeutics‘ investigational oral RIPK1 inhibitor SAR443820 in people with multiple sclerosis (MS). The clinical trial (NCT05630547) seeks to enroll about 168 patients, age 18–60, with either relapsing-remitting MS (RRMS), active and nonactive secondary progressive…

Continuous treatment with Tecfidera (dimethyl fumarate) for more than two years did not slow clinical and radiological measures of disease progression in people with primary progressive multiple sclerosis (PPMS) compared with patients who started treatment after one year. In fact, most PPMS patients remained stable with or without…

NurOwn, a stem cell therapy being developed by BrainStorm Cell Therapeutics, showed a good safety profile among people with progressive forms of multiple sclerosis (MS) in an open-label Phase 2 clinical trial, according to new data. The data show the experimental therapy also was associated with promising effects on…

VISIONARY-MS, a Phase 2 clinical trial evaluating the safety and effectiveness of CNM-Au8 in people with relapsing multiple sclerosis (MS) with disease-related visual impairment, will conclude early due to COVID-19 pandemic-related challenges. The release of trial data is expected in the second half of this year, according to…

The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants…

Flex Pharma, Inc., announced the start of a Phase 2 clinical trial assessing the safety and efficacy of FLX-787 in multiple sclerosis (MS) patients who suffer from cramps, spasms, and/or spasticity as a result of the disease. The trial is being run in conjunction with Neuroscience Trials Australia. Flex Pharma’s FLX-787 is a single molecule,…

The Tisch MS Research Center of New York (Tisch MSRCNY) recently announced that its stem cell-based therapy as a potential treatment for multiple sclerosis (MS) will move into Phase 2 clinical testing after encouraging results in a Phase 1 trial, and on the advice of  the U.S. Food and Drug…