Company News

Wegovy approved for heart diseases

Country
United States

The obesity drug, Wegovy (semaglutide), first approved in 2021 for weight control, has now been authorised in the US to reduce the risk of heart attack and stroke in adults with cardiovascular disease and either obesity or excessive weight. It is the first drug to receive Food and Drug Administration approval for both indications as evidence of the linkage between excessive weight and cardiovascular events becomes clearer.

Amylyx drug for ALS fails at Phase 3

Country
United States

A confirmatory Phase 3 trial of a drug for patients with amyotrophic lateral sclerosis (ALS) failed to meet its primary and secondary endpoints, raising the possibility that the therapy, originally approved in 2022, could be withdrawn from the market. The developer, Amylyx Pharmaceuticals Inc, announced the trial results on 8 March, saying that a voluntary market withdrawal had not been ruled out. The therapy, AMX0035, is a combination of two small molecules, sodium phenylbutyrate and taurursodiol, which each target different neurodegenerative pathways.

NodThera drug reverses neuroinflammation

Country
United States

NodThera Ltd said that its small molecule inhibitor of the NLRP3 inflammasome has shown evidence of reducing neuroinflammatory and inflammatory biomarkers in Parkinson’s disease. Data from a Phase 1b/2a a trial, disclosed on 7 March, showed that the drug, NT-0796, delivered mean reductions of these markers in the cerebrospinal fluid of elderly patients, bringing them to levels approximating those of healthy elderly controls.

Semaglutide reduces risk of kidney disease progression

Novo Nordisk A/S’s semaglutide (Ozempic), currently approved to reduce the risk of adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease, has achieved another milestone. This was evidence that the drug reduced the risk of kidney disease-related events by 24% in people with type 2 diabetes and chronic kidney disease. The data comes from the Phase 3 FLOW trial, which was stopped early in October 2023 due to efficacy. The headline results from this trial were released on 5 March.

Positive data for RNAi therapeutic for hypertension

Country
Switzerland

An investigational RNA interference (RNAi) treatment has delivered positive data in a Phase 2 trial of people with mild to moderate uncontrolled hypertension, according to the developers Roche and Alnylam Pharmaceuticals Inc. The two companies have now started another Phase 2 study of the drug, zilebesiran, in people with uncontrolled hypertension at high cardiovascular risk.

Vivoryon Alzheimer’s study fails

Country
Germany

A Phase 2b study of a small molecule drug for the treatment of early Alzheimer’s disease failed to meet its primary and key secondary endpoints, the Germany-based developer Vivoryon Therapeutics NV, announced on 4 March. The drug targets an enzyme, glutaminyl cyclase, which is thought to be responsible for the formation of toxic oligomers in the disease. Although the drug showed promising efficacy signals in an earlier Phase 2a trial, it did not show a statistically significant difference in change over time on cognition – the primary endpoint.

Phagenesis raises finance

Country
United Kingdom

Phagenesis Ltd, a UK medical technology company, has raised $42 million from EQT Life Sciences, a private equity group based in Sweden, to commercialise its recently approved device for treating swallowing disorders. The money is being provided by EQT’s Health Economics Fund that invests in late clinical stage health technology companies, or those which are just starting to bring their products to the market. Rudy Dekeyser, former managing director of the Belgian research institute VIB, is head of the fund.

BioNTech and Autolus collaborate

Country
United Kingdom

Syncona Ltd, the evergreen investment group, announced on 8 February that its portfolio company Autolus Therapeutics Plc is to collaborate with BioNTech SE to develop new therapies in oncology. The project will aim to advance both companies’ CAR T cell programmes towards commercialisation. These include BioNTech’s cell therapy for solid tumours, BNT211, and Autolus’ two CAR T cell therapy programmes, AUTO1/22, and AUTO6NG, for oncology indications. Under the terms of the agreement, BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement.

Gilead discontinues magrolimab studies

Country
United States

Gilead Sciences Inc is to discontinue studies of magrolimab, a monoclonal antibody targeting CD47 on cancer cells, following evidence that the risks associated with the drug outweigh the benefits. On 7 February the company said it was stopping a clinical programme in haematologic cancers. On 15 February it announced a partial clinical hold on four Phase 2 studies in solid tumours at the request of the US Food and Drug Administration.

Amtagvi approved by FDA

Country
United States

A cell therapy for melanoma, the first of its kind, was given an accelerated approval by the US Food and Drug Administration on 16 February for patients whose disease has progressed despite earlier treatment with a checkpoint inhibitor or a personalised cancer therapy. The therapy, Amtagvi (lifileucel), is a tumour infiltrating lymphocyte cell therapy (TIL) which consists of T cells that have been derived from a patient’s own tumour.