PIPE-791 treatment for people with idiopathic pulmonary fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

This will test two doses of PIPE-791 against placebo to see if they slow lung function decline in adults with idiopathic pulmonary fibrosis, including people already taking approved antifibrotic drugs.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Contineum Therapeutics (Industry-sponsored)
• Locations: 2 sites (Ajax, Ontario and 1 other locations)
• Trial ID: NCT07284459 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial will assign about 324 adults with IPF to one of two PIPE-791 dose arms or placebo. The active treatment period is 26 weeks with up to 36 weeks total per participant including screening and follow-up. The study will collect data on efficacy, safety, tolerability, and pharmacokinetics, and allows background antifibrotic therapy such as nintedanib or pirfenidone. Eligibility requires a confirmed IPF diagnosis per guideline criteria and adequate lung function to enroll.

Who should consider this trial

Good fit: Adults aged 40 or older with an IPF diagnosis within the past seven years and percent predicted FVC ≥ 40%, whether or not they are on approved antifibrotic treatment, are the intended participants.

Not a fit: People with non-IPF interstitial lung disease, a recent IPF exacerbation, severe kidney impairment (eGFR ≤ 30 ml/min/1.73 m2), or pulmonary arterial hypertension requiring multi-drug therapy are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, PIPE-791 could slow disease progression and help preserve lung function in people with IPF.

How similar studies have performed: Approved antifibrotic drugs have shown benefit in slowing IPF progression while investigational agents have had mixed results, so PIPE-791 is a novel candidate that still requires clinical proof of benefit.

Eligibility criteria

Key Inclusion Criteria:

* Male or female ≥ 40 years of age at the time of Randomization
* A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia
* Percent predicted (pp) FVC ≥ 40% on Screening spirometry
* Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)

Key Exclusion Criteria:

* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.

Additional inclusion and exclusion criteria apply.

Where this trial is running

Ajax, Ontario and 1 other locations

• Dynamic Drug Advancement Ltd. — Ajax, Ontario, Canada (Recruiting)
• Dr. Anil Dhar Medicine Professional Corporation — Windsor, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Nikki Nepomuceno

Conditions Idiopathic Pulmonary Fibrosis; PIPE 791; Pulmonary Fibrosis; IPF; ILD; Interstitial lung disease