Patients & Caregivers
Combining knowledge, empathy, and science to empower patients to live their lives.
Combining knowledge, empathy, and science to empower patients to live their lives.
We understand that while there have been significant advances treating hereditary angioedema (HAE), there is still further to go. Specifically, we believe that scientific advances like those we are making at KalVista will usher in a new era of oral medications with the potential to address unmet needs and empower people with HAE in their everyday lives.
The perspective of the HAE community—your perspective—is at the heart of our clinical development program for sebetralstat, our investigational, oral on-demand therapy for HAE attacks.
March 7, 2024
We are pleased to update you that KalVista has announced positive topline results from the phase 3 KONFIDENT trial. KONFIDENT evaluated the efficacy and safety of sebetralstat, an investigational oral on-demand treatment for HAE attacks.
First and foremost, KalVista would like to thank people living with HAE, their families, both the HAEA and HAEi, and investigator teams around the world for supporting this trial—the largest ever conducted in HAE—and helping to make it the first phase 3 trial of an on-demand treatment to reach positive results in over 10 years.
The perspective of the HAE community—your perspective—has been at the heart of KONFIDENT since the trial was first designed. Our clinical research team surveyed members of the HAE community and conducted in-depth patient interviews to understand how to design a primary efficacy endpoint that would meaningfully reflect how those living with HAE treat and experience attacks. We then validated this endpoint with regulators to ensure that a positive result would support a new drug application for oral sebetralstat.
KalVista will present the full results of KONFIDENT at scientific congresses later this year. We will continue to keep the community updated on these results as well as next steps on regulatory submissions in the US, EU, Japan, and other countries. Again, we express our gratitude to the patients and investigators who contributed to this study.
Sincerely,
Benjamin L. Palleiko
KalVista Pharmaceuticals, Inc.
Chief Executive Officer
In collaboration with the U.S. Hereditary Angioedema Association (HAEA), we asked 107 members of the community about their experience with HAE attacks. Here’s what we learned.
According to HAE treatment guidelines, on-demand treatment remains the foundation of HAE management. Yet, all too often, the burdens associated with current injectable treatments make them challenging to carry and use, causing people to miss the opportunity to treat at symptom onset, when HAE attack progression could be halted. Survey data underscores that oral new on-demand solutions are needed, and an oral, rapid-onset therapy could change how people treat and experience HAE attacks.
We design our clinical trials with input from the HAE community. We learned from patients about how they experienced attacks, from recognition through progression and resolution. Our goal is to demonstrate therapeutic results in a way that is most impactful for people living with HAE.
Our commitment to HAE started 10 years ago and will continue into the next decade and beyond. Our scientists are inspired by the courage of all those in the HAE community who contribute to making new advancements possible.
