HOUSTON, Texas — October 13, 2026

Oorja Bio, Inc., a clinical-stage biopharmaceutical company developing therapies for fibrotic and cardiopulmonary diseases, announced the first patient screening in its ORBIT-IPF Phase 2 clinical trial evaluating ORJ-001 for idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive lung disease characterized by scarring of lung tissue and declining respiratory function, with limited treatment options. ORJ-001 is an investigational peptide therapeutic designed to restore the function of alveolar epithelial type 2 (AEC2) cells, promote lung tissue repair and reduce inflammatory and fibrotic signaling. The randomized, double-blind, placebo-controlled, multicenter study will assess the candidate’s safety, tolerability and preliminary efficacy using an adaptive, two-part design. The program aims to investigate whether targeting the lung’s epithelial repair mechanisms could provide a disease-modifying approach for patients with IPF.

ORJ-001 Targets Alveolar Repair Mechanisms

ORJ-001 is designed as a first-in-class peptide agonist of β1 integrin, a transmembrane protein involved in cellular communication between alveolar epithelial cells and their surrounding extracellular matrix. AEC2 cells play an essential role in maintaining and repairing the lung’s alveolar lining. They contribute to epithelial regeneration and can differentiate into mature alveolar epithelial type 1 (AEC1) cells, which cover most of the alveolar surface and support normal lung function. In IPF, impaired epithelial regeneration is recognized as an important contributor to disease progression, alongside persistent inflammatory and fibrotic signaling. Oorja Bio’s approach is intended to restore AEC2 function, support alveolar repair and influence pathways associated with fibrosis. The company reports that preclinical studies in animal models of IPF showed improvements in damaged lung tissue and markers of lung function. These findings provide a rationale for evaluating ORJ-001 in human clinical studies, although animal results do not establish clinical benefit. The investigational therapy is administered subcutaneously and is intended to address underlying disease mechanisms rather than solely slow the decline in lung function. Whether it can halt progression or repair established fibrotic damage will require confirmation through clinical trial results.

ORBIT-IPF Uses a Two-Part Adaptive Study Design

The ORBIT-IPF Phase 2 trial, registered as NCT07869147, will evaluate ORJ-001 in patients with moderate IPF who are receiving standard-of-care treatment or who have discontinued such treatment because of tolerability problems or inadequate response. In Part A, investigators will assess two dose levels of ORJ-001 administered subcutaneously twice weekly against placebo over 12 weeks. The evaluation will include safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy. Part B will focus on further assessment of efficacy, with change from baseline in forced vital capacity (FVC) compared with placebo identified as the primary efficacy endpoint. FVC measures the volume of air a person can forcibly exhale after taking a deep breath and is commonly used to monitor lung function in IPF. The study will also monitor biomarkers associated with fibrosis and epithelial damage, including tenascin-C and surfactant protein D (SP-D). These biomarkers may help researchers characterize disease activity and assess biological responses to treatment. The company said the biomarker panel is under review by the U.S. Food and Drug Administration as a potential scoring system for IPF. The multinational study currently has active clinical sites in the United States, with additional enrollment expected as the program progresses.

Advertisement

cGxPJobs Banner

Funding Supports Development for an Unmet Medical Need

Oorja Bio Chief Executive Officer Sujay Kango said the initiation of ORBIT-IPF represents a significant milestone in the company’s effort to develop therapies aimed at repairing fibrosis. The company has raised $34 million in Series A financing, with investment from Westlake BioPartners and Andreessen Horowitz (a16z), to support its development strategy. Chief Medical Officer Janethe Pena, M.D., said the company believes ORJ-001’s AEC2-targeting mechanism could address an important component of IPF pathology, while clinical investigators are looking to the trial for evidence of potential patient benefit. IPF affects more than 150,000 adults in the United States, according to the company’s announcement. The disease can cause progressive scarring, respiratory failure and death, with average life expectancy often reported at three to five years following diagnosis. Approved treatments can slow disease progression but do not eliminate established fibrosis or prevent all further loss of lung function. ORJ-001 remains investigational, and its safety and efficacy have not been established in patients. The ORBIT-IPF study is expected to provide initial clinical evidence on whether the candidate can influence lung function, fibrosis-related biomarkers and other disease measures. Its results will help determine whether the approach merits further clinical development as a potential disease-modifying treatment.

Source::Oorja Bio, press release