Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-0903 · 2 trials · 3 indications
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28. A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
Number and severity of treatment emergent adverse events
Number and severity of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Part 1: TD-0903 - MAD Dose A | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose A |
| Part 1: TD-0903 - MAD Dose B | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose B |
| Part 1: TD-0903 - MAD Dose C | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose C |
| Part 1: Placebo for MAD | EXPERIMENTAL | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| Part 2: TD-0903 | EXPERIMENTAL | 99 subjects will be randomized to receive TD-0903 |
| Part 2: Placebo | EXPERIMENTAL | 99 subjects will be randomized to receive Placebo |
| TD-0903 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for SAD (Part A) | EXPERIMENTAL | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| TD-0903 for MAD (Part B) | EXPERIMENTAL | 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for MAD (Part B) | EXPERIMENTAL | 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| Name | Type | Description |
|---|---|---|
| TD-0903 | DRUG | Study Drug to be administered by inhalation |
| Placebo | DRUG | Placebo to be administered by inhalation |
Inclusion Criteria: * Willing and able to provide written informed consent on their own prior to performing study procedures. In the U.K., subject assent or proxy consent as per local site procedures, may also be acceptable if both a clinician and second health professional attest that the subject ...
TD-0903 is an investigational small molecule being developed for Acute Lung Injury (ALI) associated with COVID-19. It is designed to treat inflammatory lung conditions linked to the virus. The drug is administered via inhalation and is currently in clinical development, with studies having been completed in both healthy volunteers and patients.
TD-0903 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company has conducted clinical trials for this drug in multiple countries, including the United States, United Kingdom, and Brazil.
TD-0903 has completed Phase 2 clinical trials for Acute Lung Injury associated with COVID-19. The drug is still investigational and has not been approved by regulatory authorities. Two trials have been completed: a Phase 1 study in healthy volunteers and a Phase 2 study in patients with the condition.
TD-0903 has been studied in two completed clinical trials. The first, NCT04350736, was a Phase 1 first-in-human study in healthy volunteers in the United Kingdom. The second, NCT04402866, was a Phase 2 study in patients with Acute Lung Injury associated with COVID-19, conducted across multiple countries including the United States and Brazil.
TD-0903 is a small molecule designed to treat Acute Lung Injury associated with COVID-19. While the specific molecular target is not disclosed in available data, the drug is administered via inhalation to deliver treatment directly to the lungs, where it aims to address inflammatory lung conditions caused by the virus.