Oorja Bio, Inc.
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.
This Phase 2a/2b, randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety, tolerability, and efficacy of ORJ-001 administered subcutaneously twice weekly in adults with IPF. The study consists of two parts. Part A will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of two dose levels of ORJ-001 compared with placebo over 12 weeks of treatment. Data from Part A will be reviewed by an independent Data Monitoring Committee to select the dose for Part B. Participants in Part A will not continue into Part B; Part B will…
Key Inclusion Criteria: 1. Male or female participants aged ≥ 40 years when signing informed consent 2. Non-smoker or ex-smoker who has stopped smoking for \> 6 months prior to signing informed consent 3. Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on HRCT of the chest. The HRCT may be performed at screening or, if available, a historical HRCT obtained within 12 months from screening may be submitted for central review 4. FVC of at least 45% of the predicted value and a DLCO, corrected for t…
ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated.
Matching placebo administered by subcutaneous injection twice weekly.
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