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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |