LANGHORNE, Pa. - Savara Inc. (NASDAQ:SVRA), a biopharmaceutical company specializing in rare respiratory diseases, today announced that its Phase 3 IMPALA-2 clinical trial has met its primary and secondary endpoints.
The trial evaluated the efficacy and safety of molgramostim, an inhaled medication, in treating patients with autoimmune pulmonary alveolar proteinosis (aPAP).
The primary endpoint was the change from baseline at Week 24 in the percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO), which showed a statistically significant improvement compared to placebo. This effect was sustained at Week 48, indicating the treatment's durability.
Secondary endpoints included improvements in the St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 24 and exercise capacity at Week 48. The SGRQ measures overall health, daily life, and perceived well-being, with a negative change from baseline indicating improvement.
Molgramostim was well tolerated, with similar frequencies of adverse events in both the treatment and placebo groups. Notably, 97% of participants completed the 48-week double-blind treatment with no trial drug-related adverse events leading to discontinuation. Moreover, all patients completing the double-blind period chose to participate in a subsequent 96-week open-label period.
Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 trial, emphasized the high unmet need for effective treatments for aPAP and the potential of molgramostim as a safe and efficacious option.
Savara's CEO, Matt Pauls, expressed the company's intent to complete a Biologics License Application submission in the first half of 2025. He also highlighted the drug's favorable benefit-risk profile, which could position molgramostim as the first and only approved therapeutic for aPAP in the U.S. and Europe.
Molgramostim has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the U.S. Food and Drug Administration, as well as similar designations from European and UK regulatory agencies.
This news is based on a press release statement from Savara Inc.
In other recent news, biopharmaceutical company Savara Inc. has been the focus of analyst attention, with both Piper Sandler and Oppenheimer maintaining positive outlooks. Piper Sandler reaffirmed an Overweight rating and a $16.00 price target, expressing confidence in the upcoming IMPALA-2 data results. The firm anticipates that the forthcoming data will provide valuable insights into the market landscape and unmet needs in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
Similarly, Oppenheimer has raised its price target for Savara's shares to $11.00, up from the previous $9.50, and reiterated an Outperform rating. This adjustment follows the American Thoracic Society International Conference, where a significant increase in awareness for aPAP was highlighted. The key factor contributing to this positive outlook is the introduction of a 100% accurate diagnostic blood test for the disease.
InvestingPro Insights
Following the announcement of successful clinical trial results for Savara Inc. (NASDAQ:SVRA), investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Savara's market capitalization stands at $525.12 million, reflecting the market's current valuation of the company post-trial news. Despite the positive clinical outcomes, Savara's financial metrics indicate challenges, with a negative Price/Earnings (P/E) ratio of -10.23, and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -8.14, suggesting that the company has yet to achieve profitability.
InvestingPro Tips highlight critical financial aspects of Savara, such as holding more cash than debt, which is a positive sign for the company's balance sheet strength. However, the company suffers from weak gross profit margins, as evidenced by a gross profit of -$52.33 million in the last twelve months as of Q1 2024. Analysts are cautious, predicting that net income is expected to drop this year and do not anticipate the company will be profitable within the same timeframe. Additionally, while Savara's liquid assets exceed short-term obligations, indicating good short-term financial health, the company has not been profitable over the last twelve months and does not pay a dividend to shareholders, which could be a concern for income-focused investors.
For investors seeking a deeper dive into Savara's financial outlook and market potential, InvestingPro offers additional insights. There are 6 more InvestingPro Tips available, which can provide further guidance on the company's financial health and future prospects. Interested readers can explore these tips by visiting https://www.investing.com/pro/SVRA and can take advantage of an additional 10% off a yearly or biyearly Pro and Pro+ subscription by using the coupon code PRONEWS24.
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