Remember Mast Therapeutics? The company fell off a cliff and off investors’ radar last September after its lead candidate failed to show any statistically significant impact on treating individuals with sickle cell disease experiencing vaso-occlusive crisis. Along came Savara (Nasdaq: SVRA) to pick up the pieces in January 2017, announcing a reverse merger that closed in April. Savara picked up the balance of Mast’s pipeline, which included several candidates to treat life-threatening rare respiratory diseases.

In a press release today, Savara announced positive interim results of Aironite in an ongoing 50-patient open-label Phase 2 study of in patients with pulmonary hypertension from multiple different causes. The results were presented at the 4th Annual Drug Discovery And Development Symposium For Pulmonary Hypertension in Berlin. Aironite was shown to significantly lower pulmonary artery pressures and increase pulmonary arterial compliance. Aironite is a sodium nitrite solution for inhalation via nebulization. Nitrite is a direct vasodilator that has been shown to have multiple beneficial cardiovascular effects

Savara is also supporting two ongoing placebo-controlled institution-sponsored Phase 2 studies of Aironite in patients with heart failure with preserved ejection fraction (HFpEF), referred to as the INDIE and the INABLE studies. The main objective of the INDIE study is to assess the efficacy of Aironite on maximum exercise capacity, activity levels, and quality of life after four weeks of dosing, whereas the main objective of the INABLE study is assess the efficacy of Aironite on the same outcome measures when used in conjunction with supervised cardiac rehabilitation exercise training.

Savara raised $43 million last month in a follow-on equity offering – nearly half of which was bought by Zambon, the Italian pharmaceutical and chemicals company, and the stock has traded up from the $4.75 offering price. We’ll be interested to see what other fallen biotech angels pursue a reverse merger strategy in order to salvage any remaining clinical assets.

Source: Savara Corporate Presentation, June 2017

The company has two other candidates that are further along in clinical trials, but Aironite’s progress is critical for the company and for investors as it’s the next drug for which any top line results will be available. We’ll be keeping close watch on Savara to see if the final Phase 2 results for Aironite – expected in the first half of 2018 – confirm what the company saw in the interim results.

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