KalVista Pharmaceuticals Announces Non-Proprietary Name Selection for KVD900

Rhea-AI Summary

KalVista Pharmaceuticals has received approval for its drug candidate, sebetralstat, from the WHO and USAN. This medication is currently undergoing evaluation in a Phase 3 study named KONFIDENT, targeting on-demand treatment for hereditary angioedema (HAE) attacks. CEO Andrew Crockett expressed enthusiasm for sebetralstat's potential to be a groundbreaking oral therapy for HAE. The company is actively preparing for future regulatory submission while progressing with its ongoing clinical trials for sebetralstat and another drug, KVD824.

Positive

• Approval of sebetralstat by WHO and USAN enhances its marketability.
• Phase 3 KONFIDENT study is on track, indicating strong clinical progress.
• Potential of sebetralstat as a first oral on-demand therapy for HAE.

Negative

• None.

– “Sebetralstat” Approved by WHO and USAN –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced that the proposed name “sebetralstat” has been approved by the World Health Organization’s International Nonproprietary Names (WHO-INN) Expert Committee and the American Medical Association’s United States Adopted Names (AMA-USAN) Council for the drug candidate formerly known as KVD900. Sebetralstat is currently being evaluated in the Phase 3 KONFIDENT study as a potential therapeutic for on-demand treatment of hereditary angioedema (HAE) attacks.

“We are excited to announce this next important step in the evolution of sebetralstat as the first potential oral on-demand therapeutic for HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “The KONFIDENT study continues to enroll on track with our expectations, and we have many other activities ongoing to prepare for the eventual NDA submission. We believe sebetralstat can be a transformational therapy for people living with HAE.”

About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing sebetralstat as an oral on-demand therapy for acute HAE attacks and has initiated the Phase 3 KONFIDENT clinical trial. KVD824 is in development for prophylactic treatment of HAE, with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.

For more information about KalVista, please visit www.kalvista.com.
For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
For more information on the KVD824 HAE prophylaxis Phase 2 KOMPLETE study, please visit www.kompletestudy.com.

Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT and Phase 2 KOMPLETE clinical trials, and to obtain regulatory approvals for sebetralstat, KVD824 and other candidates in development, the ability of sebetralstat, KVD824 and other candidates in development to treat HAE or DME, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2021, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220517005285/en/

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What is the significance of the approval for sebetralstat by WHO and USAN?

The approval marks an important milestone for KalVista Pharmaceuticals, increasing the potential marketability of sebetralstat as a treatment for hereditary angioedema.

What is the current phase of the KONFIDENT study for sebetralstat?

Sebetralstat is currently being evaluated in the Phase 3 KONFIDENT study.

What condition is sebetralstat being developed to treat?

Sebetralstat is being developed for the on-demand treatment of hereditary angioedema (HAE) attacks.

Who is the CEO of KalVista Pharmaceuticals?

The CEO of KalVista Pharmaceuticals is Andrew Crockett.

What other drug is KalVista Pharmaceuticals developing alongside sebetralstat?

KalVista Pharmaceuticals is also developing KVD824 for prophylactic treatment of hereditary angioedema.