Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Inhaled TD139, TD139
GB0139 · 2 trials · 2 indications
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
| Arm | Type | Description |
|---|---|---|
| A. GB0139 3 mg once a day | EXPERIMENTAL | Inhalation of GB0139 |
| B. Placebo once a day | PLACEBO_COMPARATOR | Inhalation of Placebo |
| 0.15 mg TD139 (Part 1) | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 1.5 mg TD139 (Part 1) | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 3 mg TD139 (Part 1) | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 10 mg TD139 Part 1 | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 20 mg TD139 Part 1 | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 50 mg TD139 Part 1 | ACTIVE_COMPARATOR | 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| Placebo Part 1 | PLACEBO_COMPARATOR | 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 0.3 mg TD139 Part 2 | ACTIVE_COMPARATOR | 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. |
| 3 mg TD139 Part 2 | ACTIVE_COMPARATOR | 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. |
| 10 mg TD139 Part 2 | ACTIVE_COMPARATOR | 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. |
| Placebo Part 2 | PLACEBO_COMPARATOR | 9 Patients with IPF are administered placebo inhaled as a dry powder. |
| Name | Type | Description |
|---|---|---|
| GB0139 | DRUG | GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day. |
| Placebo | DRUG | Placebo is administered as inhalation once a day |
| Inhaled TD139 | DRUG | DPI Galectin-3 inhibitor |
Inclusion Criteria: 1. Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established during the previous five years according to ATS/ERS/Fleischner criteria. 2. Lung function parameters as follows: 1. Forced Vital Capacity (FVC) \> 45% of the predicted value at screening ...
Top 9 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Tyvaso (treprostinil) |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01, AP02 |
GB0139 is an investigational small molecule being studied as an inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF), a chronic lung disease that causes progressive scarring of the lungs. It is delivered via inhalation directly to the lungs. GB0139 is currently in clinical development and has not been approved by regulatory authorities.
GB0139 is being developed by Galecto, Inc., a biopharmaceutical company. Galecto's stock is traded under the ticker symbol DMRA. The company is focused on developing treatments for fibrotic diseases, including Idiopathic Pulmonary Fibrosis (IPF).
GB0139 is in Phase 2 clinical development. It has completed a Phase 2 trial in patients with Idiopathic Pulmonary Fibrosis (IPF). The drug is investigational and has not been approved by the FDA or any other regulatory agency. It remains in clinical development.
GB0139 has one completed Phase 2 clinical trial, identified as NCT03832946. This trial was a randomized, double-blind, placebo-controlled study that tested the efficacy and safety of inhaled GB0139 in subjects with Idiopathic Pulmonary Fibrosis (IPF). The trial enrolled 172 participants across multiple countries.
GB0139 is a small molecule that targets galectin-3, a protein involved in fibrosis, the process of scar tissue formation. By inhibiting galectin-3, GB0139 aims to reduce the progression of fibrosis in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF). It is administered via inhalation.
GB0139 is the sole name provided for this investigational drug. It is not known to be the same as any other marketed or investigational drug. It is a distinct small molecule being developed by Galecto, Inc. for Idiopathic Pulmonary Fibrosis (IPF).