De Monitor - De Pharming Expert schreef op 21 oktober 2020 15:00:
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KalVista Pharmaceuticals Provides Update on Oral Hereditary Angioedema Franchise– KVD900 Phase 2 Trial Recruitment Complete; Data Expected Before End of 2020 –
– KVD824 Achieves Targeted Exposure Levels for Prophylaxis; IND Submission Expected Q1 2021 –
– Oral Factor XIIa Inhibitor Program Announced –
October 15, 2020 07:00 AM Eastern Daylight TimeCAMBRIDGE, 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 provided an update on its franchise of oral therapies for treatment of hereditary angioedema (HAE).
“We have completed enrollment of our Phase 2 trial for our oral on-demand HAE treatment, KVD900, and remain on track to deliver data before the end of this year. We are also pleased to announce data from KVD824, our oral program for HAE prophylaxis, and to introduce our oral Factor XIIa program, which we believe represents the next generation of HAE therapeutics,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our ongoing work to optimize the exposure profile of KVD824 has yielded a formulation that maintains the concentrations we believe are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing. We intend to submit an Investigational New Drug application for a Phase 2 study to evaluate KVD824 in prevention of HAE attacks in the first quarter of 2021. Looking to the future, we are also excited to share early data on our oral Factor XIIa inhibitor program as an additional HAE therapy, with IND-enabling studies anticipated in 2021.”
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De Monitor - Jules
De Pharming Aandeel Expert