Pliant Therapeutics has terminated a Phase IIb of bexotegrast in idiopathic pulmonary fibrosis (IPF) over safety concerns, further spiralling the company’s stock.
The US-based company has announced that it has been forced to permanently stop its Beacon-IPF trial (NCT06097260) after an independent data safety monitoring (IDSM) board concluded that there was an imbalance in the number of adverse events (AEs) experienced by patients in the treatment arm of the multi-centre trial.
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The announcement comes after the company confirmed in early February that it would pause the trial awaiting the monitoring board’s decision. Following the announcement, the company’s stock value dropped by 73.7%, from $12.55 to around $3 per share. The company’s stock value has now taken a further hit of more than 59% of its value, plummeting down to $1.38 at the time of publication.
The trial recruited approximately 360 patients across 262 international sites and saw patients in the treatment arms receiving either a 160mg dose of bexotegrast or a 320mg dose, over an intended 52-week period with the trial coming to a close at the 17-week mark.
The percentage of IPF-related AEs in both dose groups was approximately 10% according to Pliant. In the company’s previous Phase IIa INTEGRIS-IPF trial (NCT04396756), there were fewer reported AEs, with diarrhoea occurring in 15 patients (16.9%) in the bexotegrast group and three patients (9.7%) in the placebo group.
Now, the company has announced that it will consider additional dose-ranging Phase IIb studies with lower doses still in IPF and other indications such as liver disease.
Leaning on the company’s other pipeline drugs, a Pliant Therapeutics spokesperson said: “Pliant is committed to the development of its other clinical and pipeline assets, including PLN-101095 in oncology.
“The company is currently enrolling the fourth of five planned dose cohorts in a Phase I open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with Keytruda (pembrolizumab) in patients with solid tumours that are resistant to immune checkpoint inhibitors.”
If bexotegrast finds its way to market, GlobalData’s Pharmaceutical Intelligence Center estimates that the drug could earn Pliant $37m by 2029, with this figure expected to rise to $119m by the end of 2030. By the end of last year, the global market for IPF therapies was estimated to be $158m, predicted to rise to $1.26bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the world of IPF, Boehringer Ingelheim’s lung disease drug nerandomilast has been successful in a Phase III study, paving the way for the company to seek approval. In January, Mediar Therapeutics signed a licensing deal with Eli Lilly to advance its human immunoglobulin G1(IgG1) antibody, MTX-463, into a Phase II trial for IPF.
