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 ...
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GB0139 is an investigational inhaled small molecule being developed for the treatment of idiopathic pulmonary fibrosis, a progressive scarring disease of the lungs. It is delivered directly to the lungs by inhalation and is in Phase 2 clinical development. It has not been approved for any indication.
GB0139 targets LOXL2, a protein enzyme involved in the crosslinking of collagen and remodeling of the extracellular matrix. By inhibiting LOXL2, the drug is designed to interfere with the fibrotic process that drives tissue scarring in idiopathic pulmonary fibrosis. LOXL2 belongs to the lysyl oxidase family of proteins.
GB0139 is being developed by Damora Therapeutics, Inc., which trades under the ticker DMRA. The company is advancing the inhaled small molecule as a potential treatment for idiopathic pulmonary fibrosis.
GB0139 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two clinical trials of the drug have been completed, and no trials are currently active.
GB0139 has been evaluated in two completed clinical trials. NCT03832946 was a Phase 2 placebo-controlled study of inhaled GB0139 in 172 patients with idiopathic pulmonary fibrosis across 15 countries. NCT02257177 was a Phase 1 randomized trial of TD139 versus placebo in 60 healthy volunteers and IPF patients in the United Kingdom.
Yes, GB0139 is also known as TD139 and inhaled TD139. These names refer to the same investigational compound. The earlier Phase 1 trial used the TD139 name, while the later Phase 2 idiopathic pulmonary fibrosis study used the GB0139 designation.