Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APL-9 · 1 trial · 9 indications
TEAEs were defined as those adverse events that developed or worsened in severity after initiation of the first dose of study drug and up to 30 (+7) days beyond the last dose of study drug. A serious TEAE was any TEAE or suspected adverse reaction that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes: death; is life threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| 180 mg APL-9 IV plus SOC | EXPERIMENTAL | - |
| Isotonic saline plus SOC | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| APL-9 | DRUG | Complement (C3) Inhibitor |
| Vehicle Control | OTHER | Normal saline of equal volume to active arm |
Inclusion Criteria: * Be at least 18 years of age at time of informed consent * Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening * Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with P...
APL-9 is an investigational small molecule being studied for the treatment of adults with mild to moderate acute respiratory distress syndrome (ARDS) caused by COVID-19. It was evaluated in a Phase 1 clinical trial that has been completed.
APL-9 is being developed by Apellis Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol APLS.
APL-9 is in Phase 1 clinical development. It has completed a Phase 1 trial, and it remains an investigational drug that is not approved by the FDA.
APL-9 has one completed clinical trial, NCT04402060, titled "A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19." The trial enrolled 72 participants and was conducted in the United States and Brazil.
Yes, the APL-9 Phase 1 trial was a randomized, double-blind, placebo-controlled study. It enrolled 72 adults with mild to moderate ARDS due to COVID-19.