Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AP01 · 2 trials · 11 indications
The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.
Change from baseline in forced vital capacity (FVC) (mL)
| Arm | Type | Description |
|---|---|---|
| Open-label AP01 treatment arm | EXPERIMENTAL | All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability. |
| AP01 High Dose BID | EXPERIMENTAL | Pirfenidone Solution for Inhalation |
| AP01 Low Dose BID | EXPERIMENTAL | Pirfenidone Solution for Inhalation |
| Placebo BID | PLACEBO_COMPARATOR | Placebo solution for inhalation |
| Name | Type | Description |
|---|---|---|
| AP01 | COMBINATION_PRODUCT | AP01 will be administered open-label via the eFlow Nebulizer System |
| Placebo | OTHER | Placebo oral inhalation solution |
Inclusion Criteria: * Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physici...
AP01 is an investigational small molecule being developed for progressive pulmonary fibrosis and other forms of pulmonary fibrosis. It is administered by inhalation. AP01 is currently in Phase 2 clinical development and has not been approved by the FDA.
AP01 is being developed by Avalyn Pharma Inc., a biopharmaceutical company. Avalyn Pharma is publicly traded under the ticker symbol AVLN.
AP01 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Avalyn Pharma is evaluating the safety and efficacy of inhaled AP01 in participants with progressive pulmonary fibrosis.
AP01 is being studied in two Phase 2 clinical trials. The first trial, NCT06329401, is evaluating the safety and efficacy of inhaled AP01 in participants with progressive pulmonary fibrosis and is active but not recruiting. The second trial, NCT06951217, is an extension study for subjects who received an Avalyn inhaled antifibrotic agent and is currently recruiting.
AP01 is not the same as SAIL. SAIL is the name of an extension study, NCT06951217, that enrolls subjects who previously received an Avalyn inhaled antifibrotic agent such as AP01. AP01 is the investigational drug being evaluated in that study.