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KalVista Pharmaceuticals presented new data on hereditary angioedema (HAE) at the EAACI Congress 2024, spotlighting significant unmet needs despite current treatments.
Key findings include the challenges of injectable on-demand therapies, with 50% of US patients experiencing untreated HAE attacks worsening in severity. Common reasons for not treating include saving medication for severe attacks and avoiding needle pain.
UK data shows 63% of patients perceive their treatment as 'early,' yet only 14% treat within one hour. Anxiety about using injectable therapies is also a major concern.
Patients who treat early recover faster and feel less anxious. There's strong patient preference for oral treatments, anticipating higher usage and less anxiety.
Physicians report significant issues with non-androgen long-term prophylaxis, including moderate to very severe attacks and high treatment burdens. KalVista highlighted the potential of oral sebetralstat to address these challenges based on positive Phase 3 KONFIDENT results.
KalVista Pharmaceuticals announced that data from the phase 3 KONFIDENT trial of sebetralstat, an oral treatment for hereditary angioedema (HAE), was published in the New England Journal of Medicine and presented at the European Academy of Allergy and Clinical Immunology Congress 2024.
The trial met its primary and secondary endpoints, with a median symptom relief time of 1.61 hours for 300 mg and 1.79 hours for 600 mg doses, compared to 6.72 hours for placebo. The safety profile was comparable to placebo, with low adverse event rates.
In the KONFIDENT-S open-label trial, sebetralstat showed a median treatment time of 9 minutes and a median symptom relief time of 1.8 hours, with consistent efficacy across various attack severities and locations.
KalVista plans to submit a new drug application to the US FDA in June 2024, and later in the EU and Japan.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of ten abstracts for presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024 in Valencia, Spain, from May 31 to June 3. Highlights include late-breaking presentations on the phase 3 KONFIDENT and KONFIDENT-S trials of sebetralstat, an oral treatment for hereditary angioedema (HAE), and multiple real-world data presentations addressing delays in injectable on-demand treatments for HAE. Key sessions are scheduled throughout the event, including oral abstracts, poster presentations, and symposiums focusing on various aspects of HAE treatment and patient experiences.
KalVista Pharmaceuticals, a clinical-stage pharmaceutical company focusing on oral, small molecule protease inhibitors, announced participation in two upcoming investor conferences. The management will join a virtual fireside chat at the Stifel 2024 Tailoring Genes: Genetic Medicines Forum on May 28, 2024, at 12:50 p.m. ET, and the Jefferies Global Healthcare Conference in New York on June 5, 2024, at 3:00 p.m. ET. The presentations will be webcasted live, with an audio archive available on the company's website for 30 days post-event.
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) granted ten newly-hired employees inducement options to purchase 94,000 shares of common stock on May 1, 2024. The options have an exercise price of $12.18 per share and vest over a four-year period. This action was taken in accordance with Nasdaq Listing Rule 5635(c)(4).
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced its strategic plans for fiscal year 2025, focusing on sebetralstat, an oral therapy for hereditary angioedema. The company aims to finalize regulatory filings in the US, EU, UK, and Japan for potential commercial launches in 2025-2026. KalVista plans to engage commercial partners, extend the product lifecycle, and reduce spending on non-core activities to achieve positive cash flow within a few years of commercial launch.
