Solskin
KalVista Pharmaceuticals (NASDAQ:KALV) said it terminated a phase 2 trial of oral drug KVD824 to prevent ((hereditary angioedema)) attacks after safety concerns related to elevated levels of a liver enzyme were seen.
The study, dubbed KOMPLETE, had begun last year after the FDA lifted a clinical hold on the study in September, which had been placed in April.
"We made the difficult decision to terminate KOMPLETE because we concluded that the emerging safety profile of the current formulation will not meet our requirements for a best-in-class oral prophylactic therapy," said KalVista CEO Andrew Crockett in an Oct. 4 press release.
In the trial, patients with HAE were divided in three groups who received either 300 mg, 600 mg or 900 mg KVD824 ( or placebo in each group).
HAE is a disorder characterized by recurrent episodes (attacks) of severe swelling of the skin and mucous membranes.
The company said 33 patients were enrolled, of which 7 patients experienced either Grade 3 or Grade 4 elevations of liver enzymes at timeframes ranging from two to 12 weeks. The elevations were seen in all treatment groups.
One additional Grade 4 elevation was recorded in a patient at the baseline visit, prior to receiving the drug, the company noted.
KalVista added that no patients had accompanying elevation of bilirubin levels and all were asymptomatic.
The company said the decision does not impact its other drug sebetralstat's (formerly KVD900) expected safety profile or Phase 3 trial called KONFIDENT for HAE attacks which continues to enroll, with data expected in H2 2023.
No treatment related liver enzyme elevations in patients have been seen in any sebetralstat studies, according to the company.
In addition, KalVista said that the oral Factor XIIa program will become primary focus for HAE prophylaxis.
"This termination conserves our financial resources and allows us to focus on continuing to advance sebetralstat through the ongoing phase 3 program and towards a planned 2024 NDA filing, as well as on our emerging oral Factor XIIa inhibitor program as a potential once daily prophylactic therapy for people with HAE," Crockett added.
- KALV -36.87% to $8.99 premarket Oct. 4