It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026. The planned sample size seems appropriate to address the primary endpoint of time to first relapse, according to the company, so that number will not change. Immunic released positive data for both studies in mid-September. The nuclear receptor related 1 activator vidofludimus calcium (IMU-838) also is being evaluated for ulcerative colitis.

FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug

Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO. Other than the manufacturing holdup, the company has already held labeling discussions with the agency, and prescribing information for CAM-2029 is in the advanced stages. The CRL does not impact two other development programs for the drug to treat gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

Cureverse, Angelini ink $360M deal for oral Alzheimer’s drug

Cureverse Inc. and Angelini Pharma SpA signed a potential $360 million deal for CV-01, an oral small-molecule candidate for Alzheimer’s disease and neurological disorders like epilepsy. As a novel candidate, CV-01 suppresses neuroinflammatory reactions through the Kelch-like ECH-associated protein 1 and nuclear factor erythroid 2-related factor signaling pathway. Currently in a South Korea-based phase I study, CV-01 demonstrated “strong potential” for disease-modifying properties across a range of neurological disorders including epilepsy, according to Rome-based Angelini.

NICE backs Mounjaro for obesity but UK’s NHS urges phased rollout

For once, the U.K.’s health technology assessment body, the National Institute of Health and Care Excellence (NICE), has no reservations about the cost effectiveness of a new drug and is recommending Eli Lilly and Co. Inc.’s obesity therapy, Mounjaro (tirzepatide), for use in the National Health Service (NHS). But with more than 25% of the adult population in the U.K. classed as obese, the eligible population is millions, and health care providers are concerned that primary care and weight loss clinics will be overwhelmed, and resources diverted from other critical services.

Can Nrx combination unlock NMDA’s oomph in akathisia?

Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s recent failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease. which missed the primary outcome measure. The NMDA landscape is “complex and represents ‘blockbuster’ size,” EF Hutton analyst Jason Kolbert noted in an Oct. 21 report. Players with phase III assets in major depressive disorder include Relmada Therapeutics Inc., with REL-1017, a channel blocker like the two approved therapies, and Seelos Therapeutics Inc., with an intranasal racemic ketamine product known as SLS-002, another channel blocker. Taking a different approach with a pair of NDA-stage assets is Nrx Pharmaceuticals Inc.

The BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level, and then reducing the need for costly or time-consuming lab experiments. Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a sponsor of the Oct. 28-30 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Lipinska.

Also in the news

Accord, Acurx, Amneal, Angelini, Astrazeneca, Avacta, Beigene, Bioaffinity, Biomea Fusion, Capricor, Cerevance, Cureverse, Daré, Dong-A, Elevar, Everest Medicines, Foresee, Galderma, Gilead, Heparegenix, Inhibikase, Inmed, Karolinska, Kintara, Lindis, Merck, Mitsubishi Tanabe, Novo Nordisk, Nurix, Quantum, Papillon, Regeneron, Regenxbio, Roche, SVF Vaccines, Tempus, Tuhura, Xbrane