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KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) has announced the publication of data from its Phase 1 clinical trials for KVD900, an oral on-demand treatment for hereditary angioedema (HAE). The study involved 98 participants and demonstrated near-complete plasma kallikrein inhibition within 30 minutes, indicating KVD900's potential for rapid relief of HAE attacks. The findings were published in the Journal of Allergy and Clinical Immunology, supporting the ongoing development of KVD900 as a promising oral therapy for patients with HAE.
Positive
KVD900 demonstrates near-complete plasma kallikrein inhibition within 30 minutes.
Study published in the Journal of Allergy and Clinical Immunology validates the drug's safety and tolerability.
KVD900 may fulfill an unmet need for rapid relief in HAE attack management.
Negative
None.
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced data from the Phase 1 clinical trials of oral, on-demand treatment KVD900 in patients with hereditary angioedema (HAE), have been published online by the Journal of Allergy and Clinical Immunology (JACI).
The objective of the Phase 1 studies was to evaluate the safety, tolerability, pharmacokinetics, and clinical pharmacology of KVD900, an orally administered inhibitor of plasma kallikrein in healthy adults. KVD900 was administered to 98 participants in total, and the data showed that KVD900 achieves near-complete plasma kallikrein inhibition within 30 minutes and was generally safe and well tolerated.
“We are pleased to see these data published in JACI to further describe our ongoing work to bring a safe, oral on-demand treatment option to the market for HAE patients,” said Andrew Crockett, Chief Executive Officer of KalVista. “These data show that KVD900 rapidly suppresses plasma kallikrein activity, a key mediator of HAE attacks, and may provide the early relief from HAE attack progression that represents a currently unmet need in orally administered management of the disease. These findings have since been further validated by the results of our Phase 2 clinical trial for KVD900.”
Additional details can be found in the manuscript, which is available in the “Articles in Press” section of the JACI website, located at: https://www.jacionline.org. JACI is an official journal of the American Academy of Allergy, Asthma, and Immunology.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of 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 KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021. 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.
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 2 KOMPLETE clinical trial, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, the ability of KVD900, 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.
KVD900 is an oral on-demand treatment developed by KalVista Pharmaceuticals for managing hereditary angioedema (HAE) attacks.
What were the results of the Phase 1 clinical trials for KVD900?
The Phase 1 trials showed that KVD900 achieved near-complete plasma kallikrein inhibition within 30 minutes and was generally safe and well tolerated among 98 participants.
How does KVD900 affect plasma kallikrein in patients?
KVD900 inhibits plasma kallikrein, a key mediator of HAE attacks, providing rapid suppression of its activity.
Where can I find more information about the KVD900 study?
Additional details about the KVD900 study are available in the 'Articles in Press' section of the Journal of Allergy and Clinical Immunology.
What are the next steps for KalVista Pharmaceuticals regarding KVD900?
KalVista is advancing KVD900 through further clinical trials to establish its efficacy and secure regulatory approval.
