Sebetralstat shows promise in treating HAE attacks

CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) shared new data at the AAAAI/WAO 2025 Joint Congress, indicating their investigational drug sebetralstat could significantly reduce the time to relief for laryngeal hereditary angioedema (HAE) attacks. The company presented findings from the KONFIDENT-S study, showcasing that sebetralstat, if approved, might offer a faster alternative to current injectable treatments.

The study reported a median time of 11.5 minutes from attack onset to treatment with sebetralstat and a median time of 1 hour and 16 minutes to the beginning of symptom relief. In comparison, U.S. survey data showed an average of 2.5 hours to treatment with existing injectable therapies. Additionally, 96% of participants experienced relief within 12 hours after a single dose of sebetralstat, with no difficulties reported in swallowing the tablet.

The effectiveness of sebetralstat in adolescents was also highlighted, with a pooled analysis from the KONFIDENT and KONFIDENT-S studies showing a median time of 4 minutes from attack onset to treatment. This is a substantial improvement compared to the median treatment time of over 3 hours noted in surveys. The safety and efficacy of sebetralstat in adolescents were found to be consistent with those in adults, with no serious adverse events or events leading to discontinuation.

Sebetralstat is a novel oral plasma kallikrein inhibitor that is currently under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. The drug represents a potential first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in younger children. The stock has shown strong momentum, gaining over 34% year-to-date, though InvestingPro analysis suggests the stock may be overbought at current levels. Analyst price targets range from $18 to $39, indicating potential upside from the current price of $11.40. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro.

HAE is a rare genetic disease characterized by painful and potentially life-threatening swelling attacks. Current on-demand treatments require either intravenous or subcutaneous administration, which can be challenging, especially for younger patients. For investors tracking biotech opportunities in rare diseases, InvestingPro offers detailed financial health scores and valuation metrics to help evaluate investment potential in companies like KalVista.

KalVista Pharmaceuticals aims to address unmet needs in rare diseases, with sebetralstat positioned as a potential foundational therapy for HAE management worldwide. The company has filed regulatory applications seeking approval for sebetralstat in multiple global markets. The information provided is based on a press release statement from KalVista Pharmaceuticals, Inc.

In other recent news, KalVista Pharmaceuticals has received Orphan Drug Designation for its drug sebetralstat from Japan’s Ministry of Health, Labour and Welfare. This designation accompanies a New Drug Application submission in Japan, aiming to introduce the first oral on-demand treatment for hereditary angioedema (HAE) in the country. The application is supported by data from the KONFIDENT phase 3 clinical trial and the ongoing KONFIDENT-S open-label extension trial, which continue to evaluate the drug’s safety and efficacy. In the U.S., sebetralstat is under regulatory review with a PDUFA goal date set for June 17, 2025.

JMP Securities has maintained a Market Outperform rating for KalVista Pharmaceuticals, with a consistent price target of $19.00. Analysts from the firm have expressed a positive outlook, highlighting the potential of sebetralstat as a significant advancement in HAE treatment. The drug is anticipated to address the needs of patients who prefer on-demand oral therapies over existing injectable options. Analysts also project that the HAE market, valued at around $900 million, could expand significantly with the introduction of sebetralstat. KalVista’s efforts in developing this treatment are seen as a promising opportunity to capture market share and meet patient needs effectively.

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