Camembert schreef op 12 juli 2022 14:16:
KALVISTA MAKING GREAT STRIDES IN DEVELOPING NEXT WAVE OF INVESTIGATIONAL COMPOUNDSKalVista Pharmaceuticals, Inc. provides an operational update and released financial results for the fiscal year ended April 30, 2022.
“We are pleased with the progress we have made over the last fiscal year in the development of the candidates in our oral HAE franchise,” says Andrew Crockett, CEO of KalVista. “We are meeting our enrollment targets for both our current clinical trials, the sebetralstat KONFIDENT Phase 3 and KVD824 KOMPLETE Phase 2. In addition, we are making great strides in developing our next wave of investigational compounds with promising preclinical data for our oral Factor XIIa inhibitor program. The Company is also well-capitalized, with funding until at least early 2024, which we expect takes us beyond data from both of our ongoing clinical trials.”
Recent highlights:
- In June 2022, the Company received formal notice that the European Commission has designated sebetralstat as an orphan medicinal product for the treatment of HAE. The orphan designation allows KalVista guaranteed access to the centralized procedure for marketing authorization, among other benefits, and would provide 10 years of market exclusivity.
- Enrollment is proceeding as expected for the Phase 3 KONFIDENT trial for sebetralstat, with data expected in the second half of 2023. The Phase 2 KOMPLETE clinical trial for KVD824, an oral plasma kallikrein inhibitor KalVista is developing for the prevention of HAE attacks, also remains on track with its enrollment targets. Data from the KOMPLETE trial is expected in mid-2023.
- Reported promising preclinical data for our oral factor XIIa inhibitor program at the KININ2022 conference. Presentations showed that our oral FXIIa inhibitors block the initiation and amplification of the kallikrein kinin system (KKS) in preclinical models as well as suppressing FXII zymogen enzyme activity.
- Announced that the name “sebetralstat” was 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.
- Published new data for sebetralstat in the journal Clinical & Experimental Allergy. In the publication, orally administered sebetralstat was shown to be quickly absorbed and provided rapid and near-complete inhibition of plasma kallikrein and strong suppression of kallikrein-kinin system activation in patients with HAE.
- Announced the initiation of the Phase 3 KONFIDENT clinical trial evaluating the efficacy and safety of sebetralstat as the first potential oral, on-demand therapy for hereditary angioedema (HAE) attacks. The worldwide, double-blind, placebo-controlled crossover trial will evaluate the efficacy of two dose levels of sebetralstat compared to placebo in adolescents and adults experiencing acute HAE attacks.
- Provided new data from the Phase 2 trial of sebetralstat at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Scientific Meeting. Data presentations highlighted the rapid suppression of plasma kallikrein activity after sebetralstat administration and its relationship with symptomatic relief from HAE attacks.