KalVista Pharmaceuticals Announces Early Completion of Enrollment in KONFIDENT-KID Pediatric HAE Trial
Initial target enrollment surpassed in fewer than seven months; trial expanded due to high demand
First data presentation expected before year-end; sNDA submission by mid-2026
“We're proud to share that we achieved target enrollment in our KONFIDENT-KID trial a full year ahead of schedule and expanded the trial size due to overwhelming interest,” said Ben Palleiko, CEO of KalVista. "The high level of participation from families living with HAE underscores the significant need for an oral treatment option for this population. Even with this larger trial size, we anticipate that initial results will be shared later this year, with an sNDA expected to be filed by mid-2026.”
Originally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately include approximately 36 patients between the ages of two and 11 across seven countries in
Currently, the only on-demand treatment for HAE patients of this age range approved in the
For more information about KONFIDENT-KID, please visit clinicaltrials.gov.
About Sebetralstat
Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.
About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the
For more information about KalVista, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
View source version on businesswire.com: https://www.businesswire.com/news/home/20250325201996/en/
Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Molly Cameron
Director, Corporate Communications
(857) 356-0164
molly.cameron@kalvista.com
Source: KalVista Pharmaceuticals, Inc.