Roche’s subcutaneous Ocrevus granted MHRA approval to treat relapsing and primary MS

Roche’s subcutaneous (SC) formulation of its Ocrevus (ocrelizumab) has been approved by the Medicines and Healthcare products Agency (MHRA) to treat adults with relapsing and primary progressive multiple sclerosis (MS).The new ten-minute injection maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, providing an additional treatment option for patients and enabling them to spend less time in hospital.Affecting more than 150,000 people in the UK, MS is a neurological disease that causes symptoms such as blurred vision, weak limbs, tingling sensations, unsteadiness, memory problems and fatigue.Relapsing-remitting MS accounts for approximately 85% of all cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery, while primary progressive MS affects about 15% of patients and is marked by steadily worsening symptoms.Roche’s Ocrevus is a disease-modifying therapy designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in people with MS.The MHRA’s latest decision on the therapy was supported by clinical trial results showing that the SC formulation is just as effective as the IV treatment, with 97% of patients experiencing no relapses in their condition and no development of brain lesions over 48 weeks. Read

In Other News

A drug has increased the lifespans of laboratory animals by nearly 25%, in a discovery scientists hope can slow human ageing too.The treated mice were known as "supermodel grannies" in the lab because of their youthful appearance.They were healthier, stronger and developed fewer cancers than their unmedicated peers.The drug is already being tested in people, but whether it would have the same anti-ageing effect is unknown. Read

Researchers from the University of Cambridge’s department of psychology have revealed that their artificial intelligence tool for predicting early Alzheimer’s disease (AD) more accurately detected the condition compared to current clinical tests. Published in eClinical Medicine, the machine learning model was able to predict whether and how fast an individual with mild memory and thinking problems will go on to develop the neurological disease. Read

Vertex Pharmaceuticals and Genomics have extended and expanded their collaboration to accelerate the discovery and development of precision medicines using human genetics and machine learning. The partners have been working together since 2018 to support Vertex’s efforts to develop medicines for serious diseases, with the collaboration now set to run until 2026. Read

US study reveals Co-STAR receptor cells show promise in treating cancers: Researchers from Johns Hopkins Kimmel Cancer Center and its Ludwig Center, along with the Lustgarten Laboratory and the Bloomberg-Kimmel Institute for Cancer Immunotherapy, have designed a novel type of cell called co-stimulatory synthetic T-cell receptor and antigen receptor (Co-STAR), which has shown potential when treating cancer. In the study published in Science Translational Medicine, researchers tested Co-STAR against human cancer cells growing in test tubes and in mice. Read

Bayer and Orion’s darolutamide has demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to new late-stage results shared by the companies. The phase 3 ARANOTE trial randomised more than 660 patients to receive 600mg of darolutamide twice daily or matching placebo, both in addition to androgen deprivation therapy (ADT). Read

Roche said on Wednesday a second drug candidate from its purchase of Carmot Therapeutics yielded positive results in an early-stage trial, as the Swiss drugmaker asserted itself as a late contender in the race to develop obesity drugs. Roche's experimental once-daily pill CT-996 resulted in a placebo-adjusted average weight loss of 6.1% within four weeks in obese patients without diabetes in a Phase I trial, Roche said in a statement.Roche's experimental pill, which could appeal to patients averse to injections, was well tolerated with mostly mild or moderate gastrointestinal side effects similar to those seen in other weight-loss drugs, according to the statement. Read

Tempus AI, Inc., a leader in artificial intelligence and precision medicine, announced that its multimodal immune profile score (IPS) algorithmic test is now available for research use only (RUO). IPS is the first in a series of immunotherapy-based diagnostics being developed by Tempus to advance algorithmic diagnostics in immuno-oncology. Tempus is also partnering with institutions like the Cleveland Clinic to expand this portfolio, utilizing clinical, laboratory, genomic, and transcriptomic data to identify patients likely to respond to immunotherapy. Read

Lexeo Therapeutics’ investigational gene therapy has shown promise as a treatment for Friedreich’s ataxia (FA) cardiomyopathy, according to new phase 1/2 data shared by the company.Affecting approximately one in every 40,000 people, FA is a neurodegenerative movement disorder and the most common form of inherited ataxia. Read

Scientists exploring potential new treatments for glioblastoma: A new approach to treating the most malignant type of brain cancer - glioblastoma - has shown strong promise in pre-clinical settings, raising hopes of increasing current average survival rates beyond 18 months.Targeted alpha therapy (TAT) is emerging as a potential additional treatment for glioblastoma (GB), a disease which has confounded oncologists for decades due to its aggressive nature and strong resistance to existing therapies. GBs are problematic because they grow very quickly and spread beyond the visible tumor into normal brain tissue, making it difficult for oncologists to deliver the optimal dosage of radiation needed to kill the cancer. Animal studies demonstrate that only a few targeting agents can effectively cross the blood brain barrier (BBB) to reach cancerous tissue, and those that do cause unwanted side effects in surrounding healthy tissue. Read

Pfizer has announced that it will be advancing a once-daily formulation of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron. The drugmaker said it plans to conduct dose optimisation studies of the candidate in the second half of 2024, following “encouraging” data from an ongoing pharmacokinetic study.Danuglipron is intended to keep blood sugar at healthy levels by increasing the amount of insulin released.Additional potential effects of the investigational medicine include slowing down food digestion and increasing the feeling of fullness after eating, which may be associated with weight loss. Read

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib).The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Read

BridgeBio, based in California, is currently testing its late-stage drug infigratinib for the treatment of achondroplasia, the most common form of dwarfism affecting approximately one in every 40,000 children, and hypochondroplasia, a milder variant of the condition. Most achondroplasia cases are caused by a sudden mutation in the FGFR3 gene (fibroblast growth factor receptor 3), which impedes bone growth, resulting in shortened limbs, poor muscle tone, and sometimes kyphosis, a condition where a curved spine causes the upper back to appear rounded. Read

Novo Nordisk’s semaglutide has been associated with a lower risk of cognitive problems, according to new research conducted by a team from the University of Oxford.The observational study suggests that people with diabetes receiving the glucagon-likepeptide-1 (GLP-1) receptor agonist, which is marketed under brand names including Ozempic and Wegovy, experienced cognitive benefits as well as lower nicotine dependence.The analysis, published in The Lancet’s eClinicalMedicine journal, used records from more than 100 million patients in the US, including over 20,000 who were taking semaglutide.The team found that the drug was not associated with an increased risk of neurological and psychiatric conditions, such as dementia, depression or anxiety, compared to other common anti-diabetic medications, challenging recent safety concerns surrounding the treatment. Read

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