Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP-R01-MG-F2 · 1 trial · 3 indications
The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver.
| Arm | Type | Description |
|---|---|---|
| [18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy Volunteers | EXPERIMENTAL | Arm1: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the lungs in the FOV is followed by two vertex-to-thigh PET/CT scans. NOTE: If the patient cannot tolerate lying down for an extended period of time at the time of imaging, the patient may be switched to scanning protocol Option B, which does not include an initial 60-minute dynamic PET/CT scan. IPF Patients will have a repeat \[18F\]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan (within 12-24 months post initial scan for previously scanned IPF patients if they are willing to be re-consented). |
| [18F]FP-R01-MG-F2 PET/CT in PSC Patients | EXPERIMENTAL | Arm 2: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the liver in the FOV is followed by two vertex-to-thigh PET/CT scans. Patients will have the option for a repeat \[18F\]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan. |
| [18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 Patients | EXPERIMENTAL | Arm 3: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. One vertex-to-thigh PET/CT scans to the center of the lung in the FOV will follow approximately 60 min post-injection. |
| Name | Type | Description |
|---|---|---|
| [18F]FP-R01-MG-F2 | DRUG | 7mCi (range 6-9mCi) \[18F\]FP-R01-MG-F2 will be administered |
1.0 Eligibility Criteria for IPF Patients 1.1 Inclusion Criteria The following inclusion criteria will be monitored: * Patient is \>/= 18 years old * Patient is capable of making an informed decision regarding his/her treatment * Patient diagnosed with IPF by a pulmonologist according to ATS guid...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
FP-R01-MG-F2 is an investigational small molecule being developed for idiopathic pulmonary fibrosis (IPF). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with IPF, a progressive lung disease characterized by scarring of the lungs.
FP-R01-MG-F2 is being developed by Pliant Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PLRX. The company is conducting clinical research on this investigational drug for the treatment of idiopathic pulmonary fibrosis.
FP-R01-MG-F2 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage clinical trials to evaluate its safety and other characteristics in humans.
FP-R01-MG-F2 is associated with clinical trial NCT03183570, titled "Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT." This early Phase 1 trial has been completed and enrolled 21 participants. The study was conducted in the United States and included healthy volunteers as well as patients with conditions such as IPF.
FP-R01-MG-F2 is a distinct investigational drug developed by Pliant Therapeutics. No alternative names for this drug have been disclosed in public clinical trial registries. It is being studied specifically for its potential role in idiopathic pulmonary fibrosis.