Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pamrevlumab · 1 trial · 1 indication
FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in the statistical analysis section. Observed data from all visits were included in the model.
| Arm | Type | Description |
|---|---|---|
| Pamrevlumab | EXPERIMENTAL | Participants will receive pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks. |
| Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib | ACTIVE_COMPARATOR | Participants will receive pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician. |
| Sub-Study: Placebo+Pirfenidone or Nintedanib | PLACEBO_COMPARATOR | Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician. |
| Name | Type | Description |
|---|---|---|
| Pamrevlumab | DRUG | Solution for infusion |
| Placebo | DRUG | Solution for infusion |
| Sub-Study: Pirfenidone | DRUG | Pirfenidone concomitant therapy will not be provided by the Sponsor. |
| Sub-Study: Nintedanib | DRUG | Nintedanib concomitant therapy will not be provided by the Sponsor. |
Inclusion Criteria: 1. Age 40 to 80 years, inclusive. 2. Diagnosis of IPF as defined by current international guidelines. Each participant must have 1 of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an available high-resolution computed tomography (HRCT) scan; or (2) Possible UI...
| 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 |
Pamrevlumab is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied to evaluate its safety and efficacy in participants with IPF.
Pamrevlumab is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company's ticker symbol is KYNB. Kyntra Bio is responsible for the clinical development of this investigational drug for Idiopathic Pulmonary Fibrosis.
Pamrevlumab is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied for the treatment of Idiopathic Pulmonary Fibrosis, and its Phase 2 trial has been completed.
Pamrevlumab has one completed Phase 2 clinical trial with the identifier NCT01890265. This trial evaluated the safety and efficacy of the drug in participants with Idiopathic Pulmonary Fibrosis. The study enrolled 160 participants and was conducted in multiple countries including the United States, Australia, and Canada.
Yes, Pamrevlumab is also known as FG-3019. The clinical trial NCT01890265, which evaluated the drug for Idiopathic Pulmonary Fibrosis, used the name FG-3019 in its title. Both names refer to the same investigational drug being developed by Kyntra Bio.
Pamrevlumab is a small molecule being developed for Idiopathic Pulmonary Fibrosis. The specific molecular target of Pamrevlumab has not been disclosed in the available information. The drug is currently in Phase 2 clinical development to evaluate its safety and efficacy in patients with IPF.