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Also known as Vancomycin inhalation powder, Vancomycin hydrochloride inhalation powder
AeroVanc · 1 trial · 2 indications
Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: "How do you feel?" or "Have you had any (other) medical problems since your last visit/assessment?" Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.
| Arm | Type | Description |
|---|---|---|
| Aerovanc 16 mg in healthy volunteers | EXPERIMENTAL | - |
| AeroVanc 32 mg in healthy volunteers | EXPERIMENTAL | - |
| AeroVanc 80 mg in healthy volunteers | EXPERIMENTAL | - |
| IV vancomycin in healthy volunteers | ACTIVE_COMPARATOR | - |
| AeroVanc 32 mg in CF patients | EXPERIMENTAL | - |
| AeroVanc 80 mg in CF patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AeroVanc | DRUG | Vancomycin hydrochloride dry powder for inhalation |
| IV vancomycin hydrochloride | DRUG | Vancomycin hydrochloride solution for intravenous administration |
Inclusion Criteria Healthy Volunteers: 1. Healthy male volunteers between 18 and 50 years of age inclusive. 2. Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form. 3. Able and willing to comply with the Protocol, including availability for all sc...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
AeroVanc is an investigational inhaled small molecule developed by Savara, Inc. for cystic fibrosis. It is delivered as an aerosol directly to the lungs and is being studied in the respiratory therapeutic area. It remains in clinical development and is not approved for commercial use.
AeroVanc is being developed for cystic fibrosis, a genetic lung disease. The clinical program has studied it in both healthy volunteers and people with cystic fibrosis, focusing on tolerability, safety, and pharmacokinetics of the inhaled formulation rather than on efficacy endpoints.
AeroVanc is developed by Savara, Inc., a biopharmaceutical company whose common stock trades under the ticker symbol SVRA. Savara is the sponsor of the AeroVanc clinical program in cystic fibrosis.
AeroVanc is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulator. The completed Phase 1 study evaluated tolerability, safety, and pharmacokinetics in 25 participants.
AeroVanc has been studied in one completed Phase 1 trial, NCT01537666, titled Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics. That study enrolled 25 participants in Australia, included healthy volunteers and people with cystic fibrosis, and used an active-controlled design.