Sebetralstat shows promise for anxiety in HAE attacks

CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) has presented new data at the HAEi Global Angioedema Forum in Copenhagen, indicating that its investigational drug sebetralstat may effectively reduce anxiety during hereditary angioedema (HAE) attacks. The findings, derived from the phase 3 KONFIDENT clinical trial, were disclosed earlier this week, with top line results initially reported in February 2024.

The KONFIDENT study is notable for being the first randomized controlled trial to evaluate the impact of an on-demand treatment on anxiety associated with HAE attacks. Dr. William R. Lumry presented an exploratory analysis that showed patients treated with sebetralstat experienced a significant reduction in anxiety compared to those who received a placebo. The study utilized a Modified Generalized Anxiety Numeric Rating Scale for self-reporting by participants.

According to the data, anxiety was notably decreased in patients taking sebetralstat at both 300mg and 600mg doses. The reduction in anxiety was also linked to earlier relief from symptoms. Dr. Lumry highlighted the potential of sebetralstat to become a valuable treatment option for HAE patients who suffer from attack-related anxiety, allowing them to address their condition earlier and recover more swiftly.

The presentations at the forum also underscored the high levels of anxiety HAE patients face, particularly when using injectable on-demand therapies. Survey results discussed at the event revealed that a significant number of respondents, especially adolescents and those with a prior anxiety diagnosis, reported moderate to extreme anxiety due to the anticipated use of on-demand treatment. The anxieties were primarily related to the effectiveness of treatment, the burden of administration, side effects, and cost/access issues.

Sebetralstat, developed by KalVista, is an oral plasma kallikrein inhibitor and has received Fast Track and Orphan Drug Designations from the U.S. FDA, along with similar designations from the European Medicines Agency (EMA). The drug is currently under review, with a PDUFA goal date set for June 17, 2025, for its potential use in treating HAE attacks in adults and adolescents.

Hereditary angioedema is a rare genetic condition characterized by painful, potentially life-threatening swelling in various parts of the body. All currently approved on-demand treatments for HAE require intravenous or subcutaneous administration.

This article is based on a press release statement from KalVista Pharmaceuticals, Inc.

In other recent news, KalVista Pharmaceuticals has made significant strides in the development of sebetralstat, a novel investigational oral treatment for hereditary angioedema (HAE). The company has submitted Marketing Authorization Applications (MAAs) for sebetralstat to regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore. The U.S. FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 17, 2025, for sebetralstat.

The company has also appointed a new CFO, Brian Piekos, bringing over 25 years of financial and strategic planning experience in the biopharmaceutical industry. Analyst firms H.C. Wainwright and Leerink Partners have reiterated a Buy and Outperform rating respectively, with a $20.00 price target. Jones Trading initiated coverage on KalVista, issuing a Buy rating with a $35.00 price target.

In addition, KalVista has initiated a pediatric trial for sebetralstat and plans to start a study for adolescent and adult patients in the fourth quarter of 2024. These recent developments are part of KalVista's ongoing efforts to provide innovative treatments for diseases with significant unmet medical needs.

InvestingPro Insights

As KalVista Pharmaceuticals (NASDAQ:KALV) advances its promising drug sebetralstat for hereditary angioedema, investors may benefit from a closer look at the company's financial health. According to InvestingPro data, KalVista's market capitalization stands at $497.84 million, reflecting investor interest in its potential breakthrough treatment.

An InvestingPro Tip highlights that KalVista holds more cash than debt on its balance sheet, which could provide financial flexibility as the company navigates the costly drug development process. This is particularly important given the upcoming PDUFA date in June 2025 for sebetralstat.

However, another InvestingPro Tip indicates that KalVista is quickly burning through cash, a common situation for biotech companies in late-stage clinical development. This burn rate underscores the importance of the potential approval and commercialization of sebetralstat for the company's financial future.

The company's financial metrics reveal a negative gross profit of $93.47 million for the last twelve months, which aligns with its pre-revenue status and ongoing R&D expenses. Despite this, KalVista's stock has shown resilience, with a one-year price total return of 27.65% as of the latest data.

Investors considering KalVista should note that analysts have set a fair value target of $33.5 per share, significantly higher than the current trading price. This suggests potential upside if sebetralstat receives approval and successfully enters the market.

For a more comprehensive analysis, InvestingPro offers additional tips and insights that could be valuable for investors evaluating KalVista's prospects in the competitive biotech landscape.

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