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Not For The Faint-hearted Though...

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The clinical trials can make or break drug companies as their stock price reaction can either be overwhelmingly positive or brutal depending upon the trial results.

The stock profiled in this section today is only for those willing to take on a high degree of risk - Savara Inc. (SVRA).

Savara is an orphan lung disease company. Its lead product candidate is Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF), in phase III development for autoimmune pulmonary alveolar proteinosis (aPAP).

Molgradex is also being studied in a phase IIa trial for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection.

Also in the pipeline are AeroVanc for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis, and aerosolized Aamikacin/Fosfomycin for bronchiectasis.

AeroVanc is under phase III development while aerosolized Aamikacin/Fosfomycin is a phase II-ready compound.

The phase III trial of Molgradex for autoimmune pulmonary alveolar proteinosis is known as IMPALA.

Autoimmune pulmonary alveolar proteinosis, or aPAP, is a rare autoimmune lung disorder affecting adults between the ages of 20-50 years. The common symptoms associated with aPAP include progressive difficulty breathing; shortness of breath upon exertion; a dry, chronic cough; fatigue; weight loss; chest pain; and a general feeling of ill health. anosis may be present. (Source: NIH).

According to the Company, IMPALA is the largest clinical study ever conducted in autoimmune pulmonary alveolar proteinosis, with a total of 139 people across 34 study sites. The top line results from this study are expected this month (June). If all goes well as planned, a Biologics License Application for Molgradex for autoimmune pulmonary alveolar proteinosis is planned for submission in the first half of 2020.

The phase IIa study of Molgradex for the treatment of NTM in people living with cystic fibrosis is known as ENCORE, and it was initiated as recently as April of this year. This trial is designed to enroll about 30 patients.

The phase IIa clinical study evaluating Molgradex for the treatment of NTM in non-CF patients is known as OPTIMA, and top-line results from the study are anticipated in Q1 2020.

Another advanced compound in the pipeline is AeroVanc, which is under a phase III trial for the treatment of persistent methicillin-resistant Staphylococcus aureus, dubbed AVAIL.

Enrollment in this trial is expected to be completed in Q3 2019, with top line results anticipated in Q2 2020.

Savara is planning to initiate a phase II study of aerosolized Amikacin/Fosfomycin combination antibiotic in non-CF bronchiectasis patients with chronic lung infection and frequent exacerbations later in 2019 or early 2020.

The Company ended March 31, 2019, with cash of roughly $105.2 million, and debt of approximately $24.7 million.

As the Company braces for the IMPALA study results, which are expected this month, it's worth keeping an eye on SVRA.

For comments and feedback contact: editorial@rttnews.com

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