CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) has reported positive results from the phase 3 KONFIDENT trial and KONFIDENT-S extension trial for the investigational drug sebetralstat, a potential new oral treatment for hereditary angioedema (HAE). The findings were presented at the European Academy of Allergy and Clinical Immunology Congress 2024 and simultaneously published in The New England Journal of Medicine.
The KONFIDENT trial, which is the largest ever in HAE, involved 136 patients and demonstrated that sebetralstat significantly reduced the time to symptom relief compared to placebo. The median time to beginning of symptom relief with sebetralstat was 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose, versus 6.72 hours with placebo. Secondary endpoints, including the time to a reduction in attack severity and time to complete attack resolution, were also met with statistical significance.
Safety data from the trial indicated that sebetralstat's safety profile was comparable to placebo, with no patient withdrawals due to adverse events and no treatment-related serious adverse events reported.
In the KONFIDENT-S open-label extension trial, interim results showed a median time of 9 minutes from attack onset to treatment with sebetralstat and a median time to beginning of symptom relief of 1.8 hours. This trial included a real-world element, allowing patients to treat attacks earlier, which could potentially minimize the severity and duration of attacks.
KalVista aims to submit a new drug application for sebetralstat to the U.S. Food and Drug Administration (FDA) in June 2024, with plans to file in the EU and Japan later in the year. Sebetralstat has already received Fast Track and Orphan Drug designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency (EMA).
The company's CEO, Ben Palleiko, expressed gratitude to the trial participants and their support networks and highlighted the significance of these results for the HAE community. If approved, sebetralstat could become the first new on-demand oral treatment option for HAE in over a decade.
The data presented in this article is based on a press release statement from KalVista Pharmaceuticals, Inc.
InvestingPro Insights
As KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) makes strides with its investigational drug sebetralstat, investors and industry observers are closely monitoring the financial health and market performance of the company. According to real-time data from InvestingPro, KalVista holds a market capitalization of $489.38 million, indicating a substantial presence in the biopharmaceutical sector.
Despite the optimistic clinical trial results, InvestingPro Tips suggest that KalVista is quickly burning through cash and analysts have revised their earnings downwards for the upcoming period. This is coupled with the fact that the company is not expected to be profitable this year, which may raise concerns about its long-term financial sustainability. However, it's worth noting that KalVista has more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, providing some financial flexibility in the near term.
InvestingPro Data also reveals a Price / Book ratio of 5.54 as of the last twelve months ending Q3 2024, which could suggest the stock is trading at a premium relative to its book value. Additionally, while the company has experienced a large price uptick over the last six months with a 33.29% return, it's important to consider that KalVista does not pay a dividend, which may influence investment decisions for those seeking income-generating assets.
For investors looking to delve deeper into KalVista's financials and market potential, more comprehensive analysis and additional InvestingPro Tips are available at https://www.investing.com/pro/KALV. With the use of the promo code PRONEWS24, users can receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to a total of 10 additional InvestingPro Tips that could further inform investment strategies.
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