KalVista Anticipates Milestones in 2 HAE Treatment Candidates in Second Half of 2020
In addition, the results of a Phase 2 clinical trial of KVD900, being investigated as an on-demand treatment for attacks in HAE, are expected to be available in the second half of 2020, KalVista announced.
“We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease,” Andrew Crockett, CEO of KalVista, said in a press release.
HAE is a chronic genetic disease characterized by sudden but temporary swelling in the deeper layers of the skin. It is caused by a lack of the functional C1-inhibitor (C1-INH) protein, which results in the increased activity of an enzyme called kallikrein. As a result of greater kallikrein activity, there is an increase in the blood levels of the inflammatory mediator bradykinin. High bradykinin levels, in turn, cause blood vessels to become more permeable, allowing fluid to leak out into tissue — in other words, causing swelling.
Both KVD824 and KVD900 work by blocking the activity of kallikrein, and thereby reducing bradykinin levels. That, consequently, reduces swelling.
KalVista announced its selection of KVD824 as a candidate for prophylactic, or preventive, treatment of HAE earlier this year.
Preliminary studies of the investigational medication are currently underway in preparation for the planned Phase 2 clinical trial. Specifically, researchers are seeking to characterize how the drug affects and is processed by the body, or its pharmacokinetics and pharmacodynamics.
“We are pleased with our progress with the formulation work for KVD824 to deliver a twice-daily treatment for prevention of HAE attacks,” Crockett said. “Subjects have begun dosing with these new formulations to obtain additional pharmacokinetic and pharmacodynamic data, and we look forward to providing these data later this year in advance of starting a Phase 2 clinical trial.”
Meanwhile, KVD900 is being tested as an on-demand treatment for swelling HAE attacks in an ongoing Phase 2 trial (NCT04208412). Its participants will be given either KVD900 or a placebo within one hour of the start of an attack, with symptoms monitored for a day after treatment. If the attacks worsen, the patients will be allowed to use their usual on-demand treatment.
The Phase 2 trial of KVD900 is currently recruiting an estimated 50 participants in the U.S. and Europe; further information is available here.
“We expect data from that trial in the second half of this year,” Crockett said.
KVD900 was previously assessed in a Phase 1 clinical trial, which showed the treatment to be well-tolerated in a group of healthy volunteers. The results from this earlier trial also indicated that KVD900 could inhibit kallikrein activity. At the highest dose (600 mg), 95% of kallikrein activity in the blood was blocked within 20 minutes of the initial dosing, and the effects lasted for up to 10 hours.