Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DSTA4637S · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DSTA4637S low dose level + SOC | EXPERIMENTAL | DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| DSTA4637S intermediate dose level+ SOC | EXPERIMENTAL | DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| DSTA4637S high dose level+ SOC | EXPERIMENTAL | DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| Placebo + SOC | PLACEBO_COMPARATOR | Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| Name | Type | Description |
|---|---|---|
| DSTA4637S | DRUG | DSTA4637S will be administered as an IV infusion at 3 dose levels. |
| Placebo | DRUG | Placebo matched to DSTA4637S IV infusion will be administered as specified. |
| SOC | DRUG | Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines. |
Inclusion Criteria: * Body mass index greater than or equal (\>/=) 18 to less than or equal to (\</=) 40 kg/m\^2 * At randomization, participants must have \>/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours * In the...
DSTA4637S is an investigational small molecule developed by Roche Holding AG for Staphylococcus aureus bacteremia, a bloodstream infection. It was studied in a Phase 1 clinical trial in adults receiving standard-of-care antibiotics. It is not an approved therapy and remains in clinical development.
DSTA4637S was studied for the treatment of Staphylococcus aureus bacteremia in adults aged 18 years and older. In the trial, participants received DSTA4637S alongside standard-of-care antibiotics. The program is investigational, so the drug is not approved for use in bacteremia or any other indication.
DSTA4637S is developed by Roche Holding AG, which trades over the counter in the United States under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in patients with Staphylococcus aureus bacteremia who were also receiving standard-of-care antibiotics.
DSTA4637S is in Phase 1 development. Its only recorded trial, NCT03162250, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA or any other regulator for Staphylococcus aureus bacteremia.
DSTA4637S has been evaluated in one clinical trial, NCT03162250, titled a study of the safety, tolerability, and pharmacokinetics of DSTA4637S in participants with Staphylococcus aureus bacteremia receiving standard-of-care antibiotics. The Phase 1 trial enrolled 27 adults, was randomized, double blind, and placebo controlled, and ran in the United States, South Korea, and Spain. It is completed.
The DSTA4637S Phase 1 trial, NCT03162250, was a randomized, double-blind, placebo-controlled study in adults with Staphylococcus aureus bacteremia who were receiving standard-of-care antibiotics. It enrolled 27 participants aged 18 years and older across the United States, South Korea, and Spain, and assessed safety, tolerability, and pharmacokinetics. The study is completed.