De Monitor - Pharming Expert schreef op 16 december 2020 12:08:
In the operational update and financial results for the second fiscal quarter ended 31 October 2020 CEO Andrew Crockett of KalVista Pharmaceuticals, Inc. says:
“We have completed the patient treatment phase of our KVD900 Phase 2 trial and are in the process of wrapping up that study. Data from this trial evaluating KVD900 as an oral on-demand treatment for HAE is expected in the first quarter of 2021. The formulation data recently shared for KVD824, our oral prophylactic treatment candidate for HAE, showed concentrations that we believe can lead to efficacy levels competitive with approved injectable therapies. We expect to submit an Investigational New Drug Application to the FDA for a Phase 2 clinical trial of KVD824 as a potential twice-daily oral treatment in the prevention of HAE attacks in the first quarter of 2021.”
Second Fiscal Quarter and Recent Business Highlights:
Completed treatment of the planned target of 50 patients in a Phase 2 clinical trial intended to evaluate the safety and efficacy of KVD900 as an oral on-demand treatment of HAE attacks. This trial is expected to provide data in the first quarter of 2021. A Pediatric Investigational Plan (PIP) has also been approved by the European Medicines Agency (EMA) for KVD900.
Provided data on KVD824 as a twice-daily oral candidate for prophylactic treatment of HAE. Work to optimize the exposure profile of KVD824 yielded a formulation that maintains the plasma concentrations KalVistabelieves are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing. An Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial is expected in the first quarter of 2021.
Announced a novel oral Factor XIIa inhibitor program as the next area of development focus. KalVista’s internal research team has discovered multiple series of oral Factor XIIa inhibitors, initially being advanced with the potential to provide the next generation of HAE therapeutics. IND-enabling studies for potential oral Factor XIIa inhibitor candidates are expected in 2021.