Status Change

Daewoong's IPF trial closes enrollment as its 2026-10-13 readout nears

The Phase 2 bersiporocin study stopped recruiting on schedule, but three primary-completion-date pushes since 2023 leave the readout's timing as the open question.

By AppliedXLJuly 16, 2026Trial NCT05389215

Executive Summary

Daewoong Pharmaceutical's Phase 2 trial of bersiporocin in idiopathic pulmonary fibrosis closed enrollment at its target and moved to Active, not recruiting, clearing the way for its primary completion.
The trial pairs a safety endpoint with a lung-function decline measure, making the readout a test of whether an HSP47-targeted antifibrotic can show a tolerability and efficacy signal distinct from the two approved standards of care.
The trial's primary completion date has moved repeatedly since it opened in 2022, and that pattern is the main variable bearing on whether the current guided window holds.
No other industry trial targets HSP47 in this disease, so the readout will be evaluated against a broader field of same-modality antifibrotics rather than a direct mechanistic rival.

The status change

The trial's status flipped from Recruiting to Active, not recruiting on the registry as of July 16, 2026. Enrollment held at its 102-patient target with no change from the prior anticipated count, a routine outcome for a Phase 2 study reaching its planned cohort size rather than a signal of trouble. A prior sponsor update said 94 of 102 patients had enrolled and that a third independent data monitoring committee had reaffirmed the trial's safety and recommended it continue, the most recent operational checkpoint before this closure. NCT05389215+1

Probability of Success

Endpoint Met40%

Completes67%

Clinical Significance25%

Regulatory71%

What the trial tests

The study, randomized and quadruple-masked with a placebo comparator, carries two primary endpoints: the incidence of treatment-emergent adverse events through Week 24, and the rate of decline in forced vital capacity (FVC) over the same period. Secondary measures include diffusing capacity for carbon monoxide, six-minute walk distance, quantitative high-resolution CT, and time to disease progression. Enrolled patients had FVC at or above 40% of predicted and diffusing capacity between 25% and 80% of predicted, a population with established but not end-stage lung impairment. No results have posted on the registry, so the trial has not yet shown whether bersiporocin separates from placebo on either primary measure. NCT05389215

Timing history

The trial's primary completion date has moved three times since the study started: from April 2024 to June 2024 in February 2023, to September 2025 in April 2024, and to October 13, 2026 in August 2025. That is a cumulative shift of roughly two and a half years from the original target. The eligibility criteria were also amended twice along the way, adding the specific FVC and diffusing-capacity thresholds now in force. None of the amendments changed the primary endpoints themselves, and no endpoint changes were made after any completion date passed. NCT05389215

The competitive frame

Bersiporocin inhibits HSP47, a collagen-chaperone target with no other industry trial testing it in idiopathic pulmonary fibrosis, making this the only Phase 2 asset in that specific target-indication pairing. The broader IPF field is active with small-molecule antifibrotics pursuing different mechanisms, including Boehringer Ingelheim's nerandomilast, a PDE4B inhibitor now in Phase 3 for interstitial lung disease, and InSilico Medicine's rentosertib, a TNIK inhibitor in Phase 3 measuring the annual rate of FVC decline over 52 weeks. None of these programs share bersiporocin's target, so the readout adds a data point on a mechanism the field has not yet tested at this scale, rather than a head-to-head comparison. With no validated disease-modifying mechanism beyond the two approved antifibrotics, a bersiporocin signal that shows a lower rate of FVC decline than placebo, without adding to the treatment-emergent adverse event rate, would be the result that distinguishes this readout from a null finding. NCT05389215

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.