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Savara Plunges on Failure of Late-Stage Study on Molgradex

Zacks

Savara Inc. SVRA announced that its lead pipeline candidate, Molgradex, failed to meet the primary endpoint in the pivotal phase III study — IMPALA — evaluating it in autoimmune alveolar pulmonary proteinosis (aPAP), a rare lung disorder.

Shares of the company crashed 71% following the news. However, Savara’s shares have rallied 39.6% so far this year compared with industry’s increase of 5.5%.

The IMPALA study evaluated Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with aPAP compared to placebo for improvement in alveolar-arterial oxygen gradient (A-aDO2) as its primary endpoint. The study evaluated two dose administrations — once daily continuous administration of and once daily in seven-day intermittent cycles — of 300 µg Molgradex over 24 weeks.


Data from the study demonstrated average improvement of 12.1 mmHg in patients receiving Molgradex administered once daily continuously compared to an improvement of 8.8 mmHg for placebo. However, the treatment difference of 4.6 mmHg failed to meet the primary endpoint.

Molgradex also failed to achieve improvement of statistical significance in two key secondary endpoints – the six-minute walk distance (6MWD) and requirement for whole lung lavage (“WLL”).

However, the candidate achieved an improvement of statistical significance of 7.6 points compared to placebo in one of the key secondary endpoints of the St. George’s Respiratory Questionnaire (“SGRQ”), a measure of quality of life.

Although Molgradex failed to meet the primary endpoint, results from the study demonstrates that the candidate has potential to be an important pharmacological treatment option for patients with aPAP.

Savara is planning to meet with regulatory authorities to discuss the study results and the future development path for Molgradex.

Apart from aPAP, the company is also developing Molgradex in a mid-stage study as a treatment for patients with nontuberculous mycobacterial lung infection. The company also has another late-stage candidate, AeroVanc, which is being evaluated in a phase III study for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in patients with cystic fibrosis. Enrollment in the study is expected to be completed in the third quarter.

Zacks Rank & Stocks to Consider

Savara currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Fibrocell Science Inc FCSC, Assertio Therapeutics, Inc ASRT and Auris Medical Holding EARS, all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Fibrocell Science’s loss estimates have narrowed from $1.38 to $1.31 for 2019 and from $1.32 to $1.13 for 2020 over the past 60 days. The stock has gained 29.4% year to date.

Assertio’s earnings estimates have increased from 78 cents to 88 cents for 2019 and from 91 cents to 95 cents 2020 over the past 60 days.

Auris’ loss estimates have narrowed from $11.60 to $2.58 for 2019 and from $16.80 to $3.77 for 2020 over the past 60 days.

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