Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FG-3019 · 6 trials · 5 indications
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
| Arm | Type | Description |
|---|---|---|
| Cohort 1/1-EX | EXPERIMENTAL | Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
| Cohort 2/2-EX | EXPERIMENTAL | Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
| FG-3019 + Gemcitabine + Nab-paclitaxel | EXPERIMENTAL | Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
| Gemcitabine + Nab-paclitaxel | ACTIVE_COMPARATOR | Participants will receive gemcitabine 1000 mg/ meter squared (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
| FG-3019 | EXPERIMENTAL | All subjects are treated with FG-3019 |
| A | PLACEBO_COMPARATOR | Placebo |
| B | EXPERIMENTAL | FG-3019 5 mg/kg |
| C | EXPERIMENTAL | FG-3019 10 mg/kg |
| FG-3019 Low Dose | EXPERIMENTAL | Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. |
| FG-3019 Medium Dose | EXPERIMENTAL | Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. |
| FG-3019 High Dose | EXPERIMENTAL | Participants will receive a single IV infusion of FG-3019 high dose on Day 0. |
| Name | Type | Description |
|---|---|---|
| FG-3019 | DRUG | Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years). |
| Gemcitabine | DRUG | Gemcitabine will be administered per dose and schedule specified in the arm group description. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel will be administered per dose and schedule specified in the arm group description. |
Main Inclusion Criteria: 1. Age 35 to 80 years, inclusive. 2. Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity). 3. History of IPF of 5 years duration or less. 4. Evidence of pro...
| 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 |
FG-3019 is an investigational small molecule being studied for idiopathic pulmonary fibrosis, pancreatic cancer, and diabetes mellitus. Clinical trials have evaluated it in patients with unresectable pancreatic cancer and in diabetic nephropathy related to type 1 or type 2 diabetes. It is not approved and remains in clinical development.
FG-3019 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. Kyntra Bio trades on the stock market under the ticker symbol KYNB. The company is conducting clinical research to evaluate the safety and tolerability of FG-3019 in several patient populations.
FG-3019 is in Phase 1 clinical development. All completed trials of FG-3019 were Phase 1 studies. These trials have finished, and no active trials are currently listed. FG-3019 is investigational and has not been approved by regulatory authorities.
FG-3019 has been studied in four completed Phase 1 trials. NCT00074698 tested it in idiopathic pulmonary fibrosis, NCT00102297 and NCT00754143 in diabetic nephropathy, and NCT02210559 in unresectable pancreatic cancer. The trials were conducted in the United States and enrolled a total of 111 participants.
Yes, FG-3019 is a small molecule therapeutic. It is being developed as a metabolic treatment, though it has also been studied in oncology and pulmonary conditions. The trials were randomized, double-blind, and placebo-controlled, indicating a rigorous study design.