Savara at a Glance
Savara Pharmaceuticals is a U.S.-based emerging pharmaceutical development company with an affiliate site in Denmark. The company is focused on advancing a pipeline of novel inhalation therapies for the treatment of patients with rare pulmonary conditions. Savara focuses on three compounds (two biologic, one small molecule) and three orphan indications.
Product / API / Indication
- AeroVanc – Inhaled dry-powder Vancomycin to treat chronic methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in Cystic Fibrosis (CF)
- Molgradex – Inhaled nebulized GM-CSF to treat Pulmonary Alveolar Proteinosis (PAP)
- Alveodex – Inhaled Factor VIIa to treat Diffuse Alveolar Hemorrhage (DAH)
Savara’s lead product candidate, AeroVanc (vancomycin hydrochloride inhalation powder), is an inhaled dry powder form of vancomycin to treat Methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. By delivering vancomycin directly to the site of infection in the lungs, the hope is that AeroVanc will improve clinical efficacy and reduce adverse effects due to lessor systemic drug exposure as compared to IV antibiotic treatment. AeroVanc is the first inhaled antibiotic for management of MRSA lung infection in CF patients.
Molgradex® (recombinant human granulocyte-macrophage colony-stimulating factor) is the first inhaled GM-CSF formulation being developed for the treatment of patients with PAP. By delivering GM-CSF directly to the lung, Molgradex® is expected to have the ability to improve clinical efficacy and reduce adverse effects compared to systemic use.
Factor VIIa (blood clotting factor) is being developed for the treatment of DAH, which is persistent or recurrent pulmonary hemorrhage. By delivering FVIIa directly to the lung, Alveodex is expected to have the ability to improve clinical efficacy and reduce adverse effects compared to systemic use.
All three conditions have an acute or chronic nature, but no current satisfactory method of treatment. Hence, there is a high unmet medical need among patients with these conditions worldwide.