Novartis Discontinues Mid-Stage Fabhalta Trial in Lupus Nephritis for Strategic Reasons

Novartis (NYSE:NVS) has discontinued a mid-stage clinical trial evaluating its oral treatment Fabhalta in patients with lupus nephritis, according to an update to a US federal clinical trials registry dated October 15.

The Swiss pharmaceutical company said the decision was based on strategic considerations and was not related to interim findings concerning the drug’s efficacy or safety.

The development was first reported by Endpoints News on Friday. Novartis confirmed that other clinical studies involving Fabhalta would continue as planned.

Clinical Trial Evaluated Fabhalta Alongside Standard Treatment

The discontinued study was designed to assess the safety and effectiveness of Fabhalta when administered alongside standard medical care for patients with lupus nephritis.

Lupus nephritis is a kidney complication associated with systemic lupus erythematosus, an autoimmune disease in which the immune system attacks the body’s own tissues.

The condition causes inflammation of the kidneys and can affect their ability to filter waste products from the blood.

Approximately half of patients with systemic lupus erythematosus develop lupus nephritis within five years, according to the information provided in the trial report.

The study began in 2022 and was structured in two parts, with approximately 80 patients expected to participate.

It included individuals with active class III or IV lupus nephritis, both with and without class V membranous features.

Researchers were assessing Fabhalta in treatment regimens that included standard care, with and without oral corticosteroids.

Novartis Completes First Study Phase Before Termination

Novartis completed the first part of the clinical trial before deciding to discontinue the programme.

The company stated that the termination was not prompted by interim efficacy or safety results, distinguishing the decision from a discontinuation based on evidence of treatment failure or an identified safety concern.

However, the company did not provide additional details about the strategic considerations underlying the decision.

Investigators involved in the study have been informed and are working with participating patients to determine appropriate next steps.

The termination means the planned clinical evaluation of Fabhalta in this particular lupus nephritis study will not proceed to completion.

Novartis indicated that its other Fabhalta clinical development programmes remain unaffected.

Fabhalta Already Approved for Three Conditions

Fabhalta, also known as iptacopan, is an oral treatment that has received regulatory approval for several conditions involving the complement system, part of the body’s immune defence mechanism.

The US Food and Drug Administration first approved the medicine in 2023 for paroxysmal nocturnal haemoglobinuria, a rare blood disorder involving the destruction of red blood cells.

The treatment subsequently received FDA approval for two kidney diseases: IgA nephropathy and C3 glomerulopathy.

IgA nephropathy is a kidney condition involving deposits of immunoglobulin A in the kidneys, while C3 glomerulopathy is a rare disease associated with abnormal activity of the complement system.

These approvals remain separate from the discontinued lupus nephritis trial.

The decision to terminate the study does not change Fabhalta’s existing regulatory approvals.

Other Fabhalta Development Programmes to Continue

Novartis confirmed that clinical trials involving Fabhalta in other indications would continue according to their existing plans.

The company’s decision to discontinue the lupus nephritis study therefore represents a change to one clinical development programme rather than a broader withdrawal of the medicine from research or commercial use.

The registry update establishes that the trial has been terminated, but the information released does not provide results from the completed first phase or indicate whether those findings will be published separately.

Further information about the company’s clinical development priorities may emerge through subsequent regulatory disclosures or programme updates.

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