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June 28, 2021

LoA Update: Novartis’ IPF drug ianalumab’s chances to move to next development stage improve by ten points after Phase II completion

Novartis’ Phase Transition Success Rate (PTSR) for its idiopathic pulmonary fibrosis (IPF) drug VAY736 (ianalumab) reached 38% after a 10-point jump that followed its Phase II trial’s completion, as of 23 June.

Novartis’ Phase Transition Success Rate (PTSR) for its idiopathic pulmonary fibrosis (IPF) drug VAY736 (ianalumab) reached 38% after a 10-point jump that followed its Phase II trial’s completion, as of 23 June.

Ianalumab is an anti-B-cell activating factor (BAFF) receptor antibody which is administered subcutaneously. The Phase II study (NCT03287414) trial was originally anticipated to recruit 84 IPF patients but stopped accrual at 30 patients, as per a 10 May update on the study’s ClinicalTrials.gov entry. The trial was started in December 2017. While the trial has completed, as per an update earlier this week, results have not yet been posted. This was a placebo-controlled study meant to evaluate ianalumab’s impact on the forced vital capacity (FVC) over a 48-week time frame. Once the trial completed, the drug’s Likelihood of Approval (LoA) also increased to 13% with a 3-point increase.

Ianalumab is also being studied in other Novartis-led trials in chronic lymphocytic leukemia, rheumatoid arthritis and systemic lupus erythematosus among other indications.

PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. The PTSR score considers characteristics like therapy area, indication and molecule type, and is used to calculate a drug’s LoA.

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