Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PLN-74809 · 4 trials · 2 indications
Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.
Nature and proportion of TEAEs between PLN-74809 and placebo groups. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug
Nature and proportion of Serious TEAEs between PLN-74809 and placebo groups. An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
| Arm | Type | Description |
|---|---|---|
| PLN-74809 | EXPERIMENTAL | 160 mg PLN-74809 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PLN-74809 Dose Level 1 | EXPERIMENTAL | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks |
| PLN-74809 Dose Level 2 | EXPERIMENTAL | Part 2, Cohort 2 Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1 |
| PLN-74809 Dose Level 3 | EXPERIMENTAL | Part 2, Cohort 3 Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 1 |
| PLN-74809 Dose Level 4 | EXPERIMENTAL | Part 3, Cohort 4 Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Levels 2 and 3 |
| PLN-74809 Dose Level 1 (Part A) | EXPERIMENTAL | PLN-74809 Dose Level 1 (Part A) - 4 weeks |
| PLN-74809 Dose Level 2 (Part A) | EXPERIMENTAL | PLN-74809 Dose Level 2 (Part A) - 4 weeks |
| PLN-74809 Dose Level 2 (Part B) | EXPERIMENTAL | PLN-74809 Dose Level 2 (Part B) - 12 weeks |
| PLN-74809 - Dose Level 3 (Part C) | EXPERIMENTAL | PLN-74809 Dose Level 3 (Part C) - 12 weeks |
| PLN-74809 - Dose Level 4 (Part C) | EXPERIMENTAL | PLN-74809 Dose Level 4 (Part C) - 12 weeks |
| PLN-74809 - Dose Level 5 (Part D) | EXPERIMENTAL | PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks |
| PLN-74809 Dose Level 1 (60 mg) | EXPERIMENTAL | PLN-74809 Dose Level 1 (60mg) |
| PLN-74809 Dose Level 2 (80 mg) | EXPERIMENTAL | PLN-74809 Dose Level 2 (80 mg) |
| PLN-74809 Dose Level 3 (120 mg) | EXPERIMENTAL | PLN-74809 Dose Level 3 (120 mg) |
| PLN-74809 Dose Level 4 (240 mg) | EXPERIMENTAL | PLN-74809 Dose Level 4 (240 mg) |
| PLN-74809 Dose Level 4 (320 mg) | EXPERIMENTAL | PLN-74809 Dose Level 4 (320 mg) |
| Name | Type | Description |
|---|---|---|
| PLN-74809 | DRUG | 160 mg PLN-74809 |
| Placebo | DRUG | Matching placebo |
| Knottin tracer | RADIATION | Radiotracer |
Inclusion Criteria: * Participants, aged 40 years or older * Diagnosis of IPF, within 8 years prior to Screening * FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening * Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; histor...
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PLN-74809 is an investigational small molecule developed by Pliant Therapeutics, Inc. for the treatment of fibrotic diseases. It is being studied in idiopathic pulmonary fibrosis and primary sclerosing cholangitis. The drug is in Phase 2 clinical development and has completed three Phase 2 trials.
PLN-74809 targets the αvβ6 and αvβ1 integrins. By inhibiting these integrins, the drug is designed to interfere with pathways involved in fibrosis. This mechanism is being evaluated in idiopathic pulmonary fibrosis and primary sclerosing cholangitis.
PLN-74809 is being developed by Pliant Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol PLRX. The company is responsible for the clinical development of the drug in idiopathic pulmonary fibrosis and primary sclerosing cholangitis.
PLN-74809 is in Phase 2 clinical development. Three Phase 2 trials have been completed, and no active trials are currently ongoing. The drug has not been approved by the FDA and remains investigational.
PLN-74809 has been evaluated in three completed Phase 2 trials: NCT05621252, an imaging study in idiopathic pulmonary fibrosis; NCT04480840, a Phase 2a trial in primary sclerosing cholangitis; and NCT04396756, a Phase 2 trial in idiopathic pulmonary fibrosis. A fourth trial, NCT04072315, assessed αvβ6 receptor occupancy using PET imaging in IPF.