Clinical Novartis freezes development of its drug due to failed...

Novartis freezes development of its drug due to failed phase 2 trial


Novartis has stopped the development of iscalimab- a drug it had developed for liver transplantation. The results of the phase 2 trial were not what was expected by the company as the drug underperformed. 

Due to evidence of the costimulatory protein’s function in immune activation, drug developers started advancing anti-CD40 candidates into the clinic more than 20 years ago, but they had to face several issues during this journey. Over the years, Novartis has been somehow successful in maintaining its confidence with 13 clinical trials taking place in the last five years. 

The third quarter results of Novartis, a Swiss pharmaceutical company, were the details of iscalimab (CFZ533). According to Novartis, a phase 2 research discovered that in liver transplant patients, tacrolimus, which Astellas Pharma’s therapy sold under the brand name Prograf, has a better risk-benefit profile than the anti-CD40 antibody.

In order to determine whether iscalimab has a better effectiveness level as compared to calcineurin inhibitor tacrolimus, Novartis started enrolling 132 participants in the phase 2 experiment in 2019. With a similar safety and tolerability profile to the existing medication, it was hoped that the candidate would lessen acute rejection, graft loss, and death as well as maybe enhance renal function.

Novartis discontinued their liver transplant medication post the phase 2 trial results which were below expectations. The cancellation, which comes 13 months after Novartis ended a kidney transplant program, still gives the company a number of chances to succeed with iscalimab.

Novartis is still researching the CD40 inhibitor in phase 2 trials for Type 1 diabetes, Sjögren’s syndrome, and lupus nephritis. Data from the 260-subject Sjögren’s trial, an immunological condition that causes dry mouth and dry eyes, are expected to be released this year. Although several data drops will need to fall in its favor, Novartis has penciled an application for approval in Sjögren’s into its calendar for 2026 or later. 

Another update given by the company was its failure of the presbyopia phase 2 trial. Presbyopia is an eye-aging disorder that makes it challenging for people to concentrate on close objects.

When Novartis acquired Encore Vision in 2016, it paid $375 million upfront to acquire the medication UNR844. However, because the candidate failed to produce a statistically meaningful dosage response at the end of the third month, the trial and the development were frozen.

The CEO of Novartis Narasimhan addressed the meeting with investors stating that the goal of the company to revolutionize the medical industry remains intact.

The CEO stated that they still have faith in this pure-play approach.

Novartis experienced 4% global growth in the third quarter, driven by sales of popular medications like Entresto, Kesimpta, Kisqali, Cosentyx, and the recently released Pluvicto. Overall, the company’s core in-market branded pharmaceuticals contributed to a 23% increase in quarterly revenue. The business has shown a positive trend in terms of growth with a 5% increase in its revenue indicating an increasing revenue curve with every passing month.

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