KalVista Pharmaceuticals Inc. shares KALV, -1.86% tumbled 47% in premarket trade Tuesday, after the company said it’s halting a Phase 2 trial of a treatment for hereditary angioedema, after multiple patients showed liver enzyme elevations. No patients had concomitant elevation of bilirubin levels and all were asymptomatic, the company said in a statement. “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,” KalVista CEO Andrew Crockett said in a statement. “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.” The trial involved 33 patients who were helping the company evaluate KVD824, an investigational oral plasma kallikrein inhibitor designed for the prevention of attacks in adults living with HAE. HAE is a rare disorder that is characterized by recurrent episodes of the accumulation of fluids outside the blood vessels, which blocks the flow of blood or lymphatic fluid and causes rapid swelling of tissues in the hands, feet, limbs, intestinal tract or airway, according to Rarediseases.org. KalVista shares have gained 7.6% in the year to date, while the S&P 500 SPX, +2.59% has fallen 23%.
