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 positive Phase 1 data for an orally disintegrating tablet (ODT). Its lead compound is the formula for sebetralstat. Sebetralstat is currently being developed as a potential on-demand treatment for hereditary angioedema (HAE) attacks in the Phase 3 KONFIDENT clinical trial.
“This new ODT formulation represents the next step in our ongoing efforts to provide HAE with more options to help people manage this disease,” said Andrew Crockett, Chief Executive Officer of KalVista. “Orally disintegrating tablets are standard in other disease areas, such as migraine, and would benefit many people with HAE, particularly younger patients. We expect this formulation to be available in the US and other countries after the initial release of sebetralstat tablets.”
KalVista recently completed a clinical trial to study the pharmacokinetics of ODT. A phase 1, open-label, randomized, single-dose, 3-way crossover trial enrolled 36 healthy adult volunteers to compare the pharmacokinetics (PK) of sebetralstat following administration of ODT and existing film-coated tablets in healthy adult volunteers. Data from the study indicated that the ODT tablet formulation had a similar PK profile to the film-coated version currently under development. Based on these results, KalVista intends to continue developing the formulation with the goal of making it available as soon as possible after sebetralstat is launched in the US. KalVista currently expects data from the KONFIDENT study using film-coated tablets to be available in the second half of 2023 to support an NDA submission planned for the first half of 2024.
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 treatment for HAE attacks and is enrolled in the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapy that could further improve the treatment of people living with HAE. In DME, a plasma kallikrein inhibitor called KVD001 has completed a phase 2 clinical trial.
For more information about KalVista, visit www.kalvista.com.
For more information on the Phase 3 KONFIDENT trial of sebetralstat HAE, please visit www.konfidentstudy.com.
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the US 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,” “could,” “could,” “should,” “could” and similar references to future periods. These statements are subject to many risks and uncertainties, including the potential impact of COVID-19, which could cause actual results to differ materially from our expectations. Examples of forward-looking statements include, among others, the timing or results of communications with the FDA , our expectations regarding the safety and efficacy of our product candidates and the timing and results of clinical trials, our ability to initiate or complete ongoing clinical trials, including our Phase 3 KONFIDENT trial and obtaining regulatory approvals for sebetralstat and other candidates in development; The ability of sebetralstat and other candidates in development to treat HAE or DME and our oral Factor XIIa the future progress and potential success of our program. Additional information about potential risk factors that could affect our business and financial results is detailed in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended April 30, 2022, our quarterly reports on the form. 10-Q and other reports we may file with the Securities and Exchange Commission from time to time. We undertake no obligation to publicly update any written or oral statements that may be made from time to time, whether as a result of new information, future events or otherwise.