Novartis to highlight ageing research at US investor day

Novartis will describe to investors later today how it is developing a series of therapies for diseases of old age – in addition to its cancer portfolio – to cater for the ageing population around the world.

Presentations due to be delivered at an event in Boston reveal that the company has a series of clinical-stage projects that will try to tackle common disorders of ageing such as ‘muscle weakness, loss of vision and hearing, heart failure and liver failure’.

The company sees these programmes as sitting alongside its oncology portfolio, which is focusing particularly on immuno-oncology therapies and its CAR-T programme that involves engineering a patient’s own immune cells to be more effective at identifying and destroying malignant cells.

According to a presentation due to be delivered today by Mark Fishman, president of the Novartis Institutes for BioMedical Research (NIBR), projects in cancer, cardiovascular medicine and eye health sit alongside more specific illnesses encountered in seniors and give the company a broad portfolio in ageing-related medicine.

“A next wave of therapeutics, based on principles of regenerative biology, is expected to address common disorders of ageing,” according to Fishman.

Headlining among the company’s programmes specifically targeting ageing is an Alzheimer’s disease (AD) programme partnered with the Banner Alzheimer Institute. This five-year study will test whether a combination of an immunotherapy and beta-secretase1 inhibitor – both targeting the amyloid protein that is a hallmark of the disease – can prevent cognitive decline in pre-symptomatic AD patients.

Novartis is also highlighting its non-alcoholic steatohepatitis (NASH) programme among its ageing portfolio, headed by non-bile acid FXR agonist LJN452, which is in early-stage clinical development. NASH is a chronic, progressive form of fatty liver disease that typically occurs in middle age or later in overweight individuals.

It has BYM338 for inclusion body myositis (IBM), an inflammatory muscle disease that leads to wasting of the limbs and is seen typically in the over-50s. BYM388 – also known as bimagrumab – is an antibody targeting the myostatin/Activin type II receptor (ActRII) pathway and has been given a breakthrough designation by the US FDA for IBM. It is in phase II testing and is also being investigated for sarcopenia – the general loss in muscle mass and strength associated with advancing age.

A related programme involves BAF312 (siponimod), a sphingosine-1-phosphate (S1P) inhibitor for another inflammatory muscle disease called polymyositis that is currently treated with steroid drugs. BAF312 is in phase II testing for polymyositis and is also being developed in phase III as a treatment for multiple sclerosis (MS).

Meanwhile, hearing loss associated with old age is the target of a gene therapy programme at Novartis – headed by GenVec-partnered CFG166 which is in phase I/II – while deteriorations in vision are addressed by several projects at Novartis’ Alcon subsidiary, including drugs for wet and dry age-related macular degeneration (AMD), dry eye and glaucoma.

The company also sees significant potential for chronic heart failure therapy Entresto (LCZ696), which could be approved later this summer, along with serelaxin (RLX030) in acute heart failure, ACZ885 for coronary artery disease and CLR235, a heart contractility agent.

The refocusing of the company’s pipeline is now complete following a transitional period for Novartis, which saw it divest animal health and vaccines operations and set up a joint venture for over-the-counter drugs, allowing it to focus on its prescription medicine and eyecare businesses.

“With the portfolio transformation behind us, management is focused on execution against our strategic priorities, including strengthening innovation across our three businesses,” said chief executive Joseph Jimenez in a statement issued this morning.

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