The Roche Group has joined the cohort of companies developing new drugs for weight loss and obesity with a decision to acquire Carmot Therapeutics Inc of California, US whose lead product is a Phase 2-ready synthetic peptide for the treatment of obesity. Under the terms of the agreement, Roche will pay $2.7 billion upfront with a further $400 million on the achievement of certain milestones.
Political leaders of the European Union reached an agreement on 9 December on the principles that should govern the regulation of artificial intelligence – the first comprehensive legal framework for AI anywhere in the world.
AbbVie Inc has joined the competition amongst large pharma companies for leadership of the market for antibody-drug conjugates (ADCs) with the proposed acquisition of ImmunoGen Inc of Waltham, Massachusetts for $31.26 per share in cash or an enterprise value of $10.1 billion. The acquisition was announced on 30 November and is expected to complete in the middle of 2024.
A Phase 3 trial of a medicine for primary immune thrombocytopenia (ITP), an autoimmune disorder that can lead to excessive bleeding and anaemia, has failed to meet its primary and secondary endpoints, the developer argenx SE announced on 28 November. The drug, Vyvgart Hytrulo (efgartigimod alfa), is an antibody fragment targeting the neonatal Fc receptor. Vyvgart has been approved in the US for generalised myasthenia gravis, another autoimmune disease, in both intravenous and subcutaneous formulations.
Immunocore Holdings Plc, a developer of T cell receptor immunotherapies, has reported third quarter revenue for its first approved product, Kimmtrak (tebentafusp), for metastatic uveal melanoma. The therapy was approved in both the US and the EU in 2022. In the third quarter Kimmtrak delivered net sales of £49.7 million, an increase of 9% from a year earlier. Of this sum, £34.5 million was generated in the US; £15 million from Europe; and £0.2 million from the rest of the world. Since its first authorisation, Kimmtrak has been approved in more than 35 countries.
Freeline Therapeutics Holdings Plc, a UK gene therapy company, is to become a private company once again following an agreement with a portfolio company of Syncona, its majority shareholder and co-founder, to acquire all of the shares that Syncona doesn’t already own. Syncona co-founded Freeline in 2015 with the aim of developing gene therapies for chronic debilitating diseases. In 2020, Freeline went public with the issue of 8.8 million American Depositary Shares (ADSs) on the US Nasdaq market, raising $158.8 million.
The world’s first regulatory approval of a gene-edited therapy, Casgevy (exagamglogene autotemcel), was issued by the UK Medicines and Healthcare products Regulatory Authority (MHRA) on 16 November, paving the way for the launch in the UK of a new treatment for sickle cell disease and transfusion-dependent beta thalassaemia. Both diseases are inherited blood disorders that affect red blood cells which are essential for carrying oxygen to all organs and tissues in the body.
Sonelokimab, a single-domain antibody product, has achieved positive results from a Phase 2 trial of patients with active psoriatic arthritis. The ARGO trial, which enrolled 207 patients, met its primary endpoint with a statistically significant greater proportion of patients treated with the antibody achieving an American College of Rheumatology 50 response compared with those on a placebo at week 12. Secondary endpoints such as minimal disease activity also showed promising levels of response at week 12, according to the developer MoonLake Immunotherapeutics AG of Switzerland.
Results from a Phase 3 trial evaluating semaglutide (Wegovy) as a treatment for adults with cardiovascular disease have shown a statistically significant 20% reduction in the risk of major adverse cardiovascular events. The results, disclosed on 11 November, were simultaneously published in the New England Journal of Medicine. Called SELECT, the placebo-controlled trial enrolled 17,604 adults in 41 countries. The participants had an established cardiovascular disease and were overweight or obese but without diabetes.
A Phase 3 trial investigating a potential new treatment for atrial fibrillation has been stopped early because of inferior efficacy, Bayer AG announced on 19 November. The trial OCEANIC-AF, was investigating asundexian, a, small molecule drug being studied in patients with atrial fibrillation (AF) at risk of stroke. It was seen as a potential alternative to traditional anticoagulants for the treatment of AF, an irregular and often very rapid heart rhythm.