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Clinical Daily Summary

Clinical Daily Summary: What Happened on October 9, 2026

Endeavor’s taladegib meets Phase IIb endpoints in pulmonary fibrosis

Newron plans cardiac and genetic screening to address an FDA pause on US enrollment. Alpheus opened a study of ultrasound therapy for glioblastoma.

  • Updated
  • Read from 4 articles, 3 publications

Today in brief

Endeavor BioMedicines said taladegib met the primary and several key secondary endpoints in a Phase IIb trial, improving lung-function measures versus placebo at 24 weeks.1 Newron plans to propose cardiac and genetic screening to lift the FDA’s pause on US enrollment in its Phase 3 evenamide study, after the agency cited five deaths across clinical studies.2

Taladegib improved lung-function measures in a Phase IIb fibrosis trial

Endeavor BioMedicines said its Phase IIb WHISTLE-PF trial met its primary and several key secondary endpoints in idiopathic pulmonary fibrosis, a progressive lung-scarring disease.1 Among 213 participants, taladegib significantly improved percent-predicted forced vital capacity compared with placebo at 24 weeks.1 Forced vital capacity measures how much air a person can force out of the lungs.1

The study also found advantages over placebo in absolute forced vital capacity and several lung-imaging measures.1 Questionnaire scores improved numerically, but the trial was not designed to determine whether that difference was statistically significant.1 Serious adverse events occurred at comparable rates in the taladegib and placebo groups, and tolerability was consistent with earlier research.1

Newron proposes screening to address the FDA’s evenamide enrollment pause

Newron Pharmaceuticals plans to ask the FDA to lift its US enrollment pause on the Phase 3 ENIGMA-TRS 2 study by screening participants for Brugada syndrome and other sodium-channel disorders, potentially with genetic tests.2 The FDA first halted enrollment in April after a sudden death at a non-US site, then maintained the pause in September.2

The agency cited five deaths across evenamide’s clinical studies, including four among people taking the drug and one among placebo recipients.2 Newron executive Ravi Anand said the four patients taking evenamide had shown no heart symptoms or ECG abnormalities.2 Anand described one patient choking while eating bread, months after a similar incident, and said neither Newron nor the FDA had identified an explanation for the deaths.2

The FDA says a standard ECG cannot reliably rule out hidden sodium-channel disorders in people without symptoms.2 The separate ENIGMA-TRS 1 study is unaffected by the pause and is expected to report its primary 12-week findings in the first quarter of 2027.2

Also worth knowing

  • Alpheus Medical opened recruitment at Buffalo’s Dent Neurologic Institute for a study of its PoMA therapy, oral 5-ALA combined with low-intensity ultrasound, alongside standard care for newly diagnosed butterfly glioblastoma.3

  • Cardiovascular developers are reassessing secondary prevention after late-stage programs targeting IL-6, Lp(a), and Factor XI failed despite substantial genetic or biological support for those targets.4

Also published