Tiziana Life Sciences‘ intranasal spray foralumab continues to be safe and well-tolerated, with no drug-related serious side effects reported after long-term use, according to an annual report filed with the U.S. Food and Drug Administration (FDA). The company is developing foralumab for neuroinflammatory diseases such as multiple…
SPMS
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…
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…
The U.S. Food and Drug Administration (FDA) has given tentative approval to Lupin’s Siponimod tablets, a bioequivalent version of Mayzent (siponimod), to treat people with relapsing forms of multiple sclerosis (MS). According to a company press release, the therapy is indicated for use in adults with clinically isolated syndrome,…
Adherence to either the Mediterranean or the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diets was associated with better performance in certain areas of thinking and memory among people with multiple sclerosis (MS), a U.K. study suggests. The Mediterranean diet reflects foods traditionally eaten in countries around the Mediterranean Sea.
Obexelimab, a therapy Zenas Biopharma is developing for a range of autoimmune diseases, almost completely prevented the formation of new inflammatory lesions in adults with relapsing forms of multiple sclerosis (MS) in the first three months of a clinical trial. That’s according to data from the first part…
Abnormal brain cells, known as disease-associated radial glia or DARGs, may play a key role in driving chronic inflammation in people with progressive forms of multiple sclerosis (MS), a new study shows. Based on the finding, researchers are now working to better understand the biology of DARGs, with an…
Zenas Biopharma has acquired global rights to develop the BTK inhibitor orelabrutinib to treat multiple sclerosis (MS) and other diseases. The deal with orelabrutinib’s developer, Innocare Pharma, includes rights to two other investigational therapies. Zenas will pay Innocare up to $100 million in cash and up to…
Some older people with multiple sclerosis (MS), namely those older than 60, may be able to safely discontinue disease-modifying therapies (DMTs) as long as they continue to be regularly monitored for new disease activity, a new study suggests. The findings showed that people older than 50 generally experience an…
Immunic Therapeutics will receive a new U.S. patent covering its experimental therapy, vidofludimus calcium, and some related molecules in people with multiple sclerosis (MS). Titled “Treatment of multiple sclerosis comprising DHODH inhibitors,” the patent explicitly covers the use of the molecules in progressive types of MS, including primary…
The United Arab Emirates became the first country to approve tolebrutinib, clearing it to treat adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). Sanofi’s oral BTK inhibitor is also the first approved therapy that directly addresses the chronic inflammation that contributes to disability progression independent of relapses. “The…
The International Progressive MS Alliance has introduced the MS Clinical and Imaging Data Resource, or CIDR, to accelerate the search for effective treatments for progressive forms of multiple sclerosis (MS) where options are limited. The resource was built in partnership with McGill University in Canada, as well as…
About 62% of multiple sclerosis (MS) patients use disease-modifying therapies (DMTs) before and during pregnancy, and the medications don’t appear to harm their health or their babies’ health, recently reported data from an international registry show. Most pregnancies resulted in live, full-term births, and these births generally occurred…
A person’s total number of visits to multiple sclerosis (MS) clinics is not associated with a lower risk of death, suggesting that merely increasing the number of clinical follow-up visits is not enough to improve survival, a new study in Denmark found. Instead, factors such as being female, having…
The rates of people with multiple sclerosis (MS) who advance from a relapsing disease course to a secondary progressive one have decreased significantly in the past decades, a 30-year study in Italy shows. While the greater availability and earlier use of disease-modifying therapies (DMTs) have played a role,…
A multicenter Phase 2a clinical trial testing foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has begun dosing patients at Weill Cornell Medicine Multiple Sclerosis Center in New York. The Phase 2a study (NCT06292923) is assessing the safety and efficacy of Tiziana Life Sciences‘ therapy,…
People who develop multiple sclerosis (MS) at a younger age tend to consistently have better physical health but worse mental health than those diagnosed later, a study found. While physical health declined in the long term for all age groups, and mental health increased, the differences between groups were…
Among people in New Zealand, the proportion of individuals with multiple sclerosis (MS) — the disease’s prevalence, or how common it is — has grown by about one-third in recent decades, a new study found. In 2006, 72.4 of every 100,000 people who lived in the country had MS,…
Cognitive symptoms, mood disorders, and fatigue manifest differently in relapsing-remitting and progressive forms of multiple sclerosis (MS), a study found. “[O]ur results indicate that the subtype of MS is associated with … specific kinds of cognitive deficits, suggesting the need for subtype-specific therapeutic interventions,” the France-based research team…
Factors including being male, smoking, and having more frequent relapses are linked to significantly increased risk of disease progression in multiple sclerosis (MS), according to a meta-analysis of several published studies. Other variables linked to disease progression included disability score and the use of disease-modifying therapies (DMTs). “Hence,…
Stem cells from donated placentas appear safe and may help reduce symptoms of secondary progressive multiple sclerosis (MS), according to a small, open-label Phase 1 clinical trial involving five patients. “Our results suggest possible neuroprotective effects” from these stem cells, researchers wrote in “Cell therapy with placenta-derived mesenchymal…
Foralumab was well tolerated in people with nonactive secondary progressive multiple sclerosis (SPMS), according to data from a small, open-label study conducted under an expanded access program. The therapy, being developed by Tiziana Life Sciences, also eased fatigue and lessened disability in some participants. The promising findings formed…
A new machine learning tool, a form of artificial intelligence (AI), may accurately detect the transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS) — and may be able to do so even earlier than clinicians can — a new study showed. According to the…
While a four-month progressive resistance training program improved muscle strength in people with secondary progressive multiple sclerosis (SPMS) in the Netherlands, it did not significantly change their risk of developing cardiovascular disease, a small study showed. Individual cardiovascular risk factors and 10-year risk estimation tools showed no significant changes…
The healthcare costs of secondary progressive multiple sclerosis (SPMS) are high, according to a real-world study in Spain, and higher still for younger patients and those with severe disability who cannot walk unaided, even for short distances. On average, yearly costs for one patient amount to more than €41,000…
Kyverna Therapeutics’ CAR T-cell therapy candidate KYV-101 was deemed safe and well tolerated, and showed preliminary signs of efficacy, in people with progressive forms of multiple sclerosis (MS) in clinical testing. That’s according to data from two investigator-initiated Phase 1 trials, which enrolled individuals with secondary progressive…
Sanofi‘s oral BTK inhibitor tolebrutinib significantly delayed the onset of six-month confirmed disability progression compared with a placebo, by 31%, in people with nonrelapsing secondary progressive multiple sclerosis (SPMS). That’s according to recently published data from the HERCULES Phase 3 trial (NCT04411641), where the experimental therapy…
People of Asian descent tend to be younger than white people when they first exhibit symptoms of multiple sclerosis (MS), a U.S. study reports. Asians also tended to be younger at the time of their diagnosis. No differences were found in demographics or disease characteristics between Asian patients…
The AdventHealth Neuroscience Institute is recruiting patients for a Phase 1b clinical trial testing IDP-023, an off-the-shelf cell-based treatment that Indapta Therapeutics is developing for primary or nonactive secondary progressive multiple sclerosis (MS). The company delayed the study’s expected launch in the second half of last…
A multicenter Phase 2a clinical trial testing Tiziana Life Sciences’ foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has dosed the first patients enrolled at Yale MS Center. The Phase 2a study (NCT06292923) is assessing the treatment’s safety and efficacy against a placebo in…