Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP01 · 3 trials · 3 indications
Change in start-to-end difference in cough count, active vs. placebo treatment periods
Plasma PK profiles: various PK indices including, but not limited to, peak plasma concentration (Cmax), Area under the plasma concentration versus time curve (AUC), and elimination half-life (T1/2), and time to peak plasma concentration (Tmax).
Safety and Tolerability will take into account the recorded AEs, vital signs, and clinical and laboratory assessments.
| Arm | Type | Description |
|---|---|---|
| FP01 6mg or Placebo | EXPERIMENTAL | FP01 6mg Oral |
| FP01 12mg or Placebo | EXPERIMENTAL | FP01 12mg Oral |
| FP01 High dose | EXPERIMENTAL | - |
| FP01 Low dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| FP01 Dose 1 | EXPERIMENTAL | Drug |
| FP01 Dose 2 | EXPERIMENTAL | Drug |
| FP01 Dose 3 | EXPERIMENTAL | Drug |
| Comparator | ACTIVE_COMPARATOR | Drug |
| Name | Type | Description |
|---|---|---|
| FP01 | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits * Subjects must be able to read and write English * Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35...
FP01 is an investigational small molecule being developed for respiratory conditions, specifically acute cough, chronic refractory cough, and as a treatment in healthy volunteers. It is formulated as a lozenge and has been studied in clinical trials for its antitussive, or cough-suppressing, effects.
FP01 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AVTX. The company has sponsored clinical trials to evaluate the safety, pharmacokinetics, and antitussive effects of FP01 lozenges.
FP01 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including studies in healthy volunteers, acute cough, and chronic refractory cough. FP01 is not FDA approved and remains an investigational drug.
FP01 has completed three clinical trials: NCT01579526, a Phase 1 study in healthy volunteers; NCT01597349, a Phase 2 study in acute cough; and NCT01703923, a Phase 2 study in chronic refractory cough. All trials are completed, with no active trials currently ongoing.
FP01 is a distinct investigational small molecule formulated as a lozenge. It is being studied specifically for its antitussive effects in acute and chronic refractory cough. No alternative names for FP01 have been disclosed in the clinical trial data.