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 inhaled small molecule being studied for the treatment of acute lung injury (ALI) associated with COVID-19, including lung inflammation linked to the virus. It is not approved for any indication and remains in clinical development. Theravance Biopharma developed it as a potential therapy for hospitalized patients with inflammatory lung conditions.
TD-0903 targets JAK, a kinase involved in inflammatory signaling. By inhibiting JAK, the drug is designed to dampen the inflammatory response in the lungs. It is delivered by inhalation, which aims to concentrate activity in the lung tissue of patients with acute lung injury associated with COVID-19.
TD-0903 is being developed by Theravance Biopharma, Inc., which trades on the Nasdaq under the ticker TBPH. The company advanced the compound as an inhaled JAK inhibitor for acute lung injury associated with COVID-19. Development has moved through Phase 1 and Phase 2 clinical testing.
TD-0903 has completed Phase 2 clinical development for acute lung injury associated with COVID-19. It is an investigational drug and has not been approved by the FDA for any indication. Two trials have been completed, including a Phase 1 first-in-human study and a Phase 2 study, with no trials currently active.
TD-0903 has been evaluated in two completed trials. NCT04350736 was a first-in-human Phase 1 single and multiple ascending dose study in the United Kingdom with 54 participants. NCT04402866 was a Phase 2 trial in acute lung injury associated with COVID-19 that enrolled 235 patients across the United States, Brazil, Finland, Moldova, Romania, Ukraine, and the United Kingdom.
Yes. The Phase 2 trial of TD-0903, NCT04402866, was a randomized, double-blind, controlled study in patients with acute lung injury associated with COVID-19. It enrolled 235 participants aged 18 years and older across seven countries. The trial has been completed, and no TD-0903 trials are currently active.