Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).

The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.

• Study Sponsor: Pliant Therapeutics, Inc.
  
  
• Start Date: November 2023
  
  
• Estimated Primary Completion Date: August 2025
  
  
• Phase 2, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of Bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)

Primary Outcome Measure:

• Change from baseline in absolute FVC (mL) [Timeframe: 52 weeks]

Inclusion Criteria:

• ≥ 40 years of age prior to screening.
• IPF diagnosis ≤ 7 years prior to screening.
• FVCpp ≥ 45%.
• Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%.
• Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening.
• If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening.

Exclusion Criteria:

• Receiving pharmacologic therapy for pulmonary hypertension.
• Self-reported smoking of any kind (not limited to tobacco).
• History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ.
• Hepatic impairment or end-stage liver disease.
• Renal impairment or end-stage kidney disease requiring dialysis.
• Pregnant or lactating female participant.
• Uncontrolled systemic arterial hypertension.
• Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF.
• Prior administration of bexotegrast.
• Likely to have lung transplantation during the study (being on transplantation list is not an exclusion).
• Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening.
• Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization.
• Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening.