Oorja Bio screens first patient in Phase 2 IPF trial of ORJ-001
Oorja Bio has initiated its ORBIT-IPF Phase 2 clinical trial (NCT07869147), screening its first patient in a study evaluating ORJ-001, a peptide therapeutic designed to treat idiopathic pulmonary fibrosis (IPF). The Houston-based company is positioning ORJ-001 as a first-in-class agent targeting alveolar epithelial type 2 (AEC2) cells, with the aim of promoting lung tissue repair and reducing fibrotic signalling rather than simply slowing decline.
Oorja Bio closed a $34 million Series A financing round from Westlake BioPartners and Andreessen Horowitz (a16z) to fund the programme. The company did not disclose when the round closed or provide a post-money valuation.
How the trial is designed
ORBIT-IPF is a randomised, double-blind, placebo-controlled, multi-centre adaptive study structured in two parts. Part A will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy at two subcutaneous dose levels, administered twice weekly over 12 weeks compared with placebo. Part B will use change from baseline in forced vital capacity (FVC) as the primary efficacy endpoint, a well-established measure in IPF trials.
The study will also track fibrosis biomarkers tenascin-C and surfactant protein D (SP-D), both of which the FDA is currently evaluating as part of a biomarker qualification programme for IPF. That regulatory process, reported in early 2026, could prove significant: validated biomarkers for IPF would reduce reliance on long, expensive outcome-driven studies and offer developers a faster route to meaningful clinical signals. Patients eligible for enrolment include those with moderate IPF who are either on standard-of-care therapy or who discontinued it due to tolerability issues or inadequate response.
Toby Maher, Professor of Medicine at the University of Southern California and a named investigator, said existing approved therapies can slow the rate of lung function decline but that "this challenging disease continues to progress and patients often struggle with side effects linked to standard-of-care medications." ORJ-001's mechanism, acting as a peptide agonist of β1 integrin to regulate AEC2 cell fate and reduce inflammatory signalling, is presented by Oorja as an attempt to address that gap.
Market context and competitive landscape
IPF is a progressive and fatal lung condition affecting more than 150,000 adults in the United States, with median survival of three to five years from diagnosis. The approved standard-of-care treatments, pirfenidone and nintedanib, are antifibrotic small molecules that reduce the rate of FVC decline but do not halt or reverse disease. That therapeutic ceiling has made IPF an active area for drug development, with multiple programmes targeting epithelial repair, senescence, and novel antifibrotic pathways at various stages of clinical development.
Oorja's AEC2-restoration approach is mechanistically distinct from the approved agents and from several late-stage competitors pursuing TGF-beta inhibition or autotaxin blockade. Whether that mechanistic differentiation translates into a superior clinical profile will depend on the ORBIT-IPF readout, and the company's two-part adaptive design should provide an interim signal on biomarker activity before committing to Part B endpoints. Andreessen Horowitz's participation in the Series A is notable; the venture firm has not historically been a heavy investor in pulmonary disease, and its involvement may reflect broader confidence in peptide-based repair approaches across fibrotic indications. Study sites are currently active in the United States, with a multi-country expansion planned.