KalVista Plans Quick FDA Filing After Phase III Success In On-Demand HAE Therapy

The firm’s oral kallikrein inhibitor might offer a better overall profile for on-demand treatment than currently approved therapeutic and prophylactic agents, analysts said.

Rare Diseases
KalVista hopes it has the latest advance in rare disease HAE • Source: Shutterstock

About 15 months after ending development of a different hereditary angioedema candidate due to liver safety worries, KalVista Pharmaceuticals, Inc. reported what analysts called best-case scenario results for its Phase III oral kallikrein inhibitor sebetralstat (KVD900) on 13 February. With the data in hand, KalVista said it plans to file sebetralstat for on-demand therapy in HAE by midyear, with expectations that it might become a foundational treatment for the rare swelling disorder.

More from Clinical Trials

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
• By 

After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.

Baxdrostat, AstraZeneca’s Next Big CVRM Bet

 
• By 

The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.

Merck’s Winrevair Slashes Morbidity-Mortality Risk For PAH Patients

 

The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.

Vertex Ends One Type 1 Diabetes Cell Therapy, Shifts Focus To Another

 
• By 

Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.

More from R&D

Corcept’s Relacorilant Shows Benefit In Ovarian Cancer, Expanding Pipeline Opportunity

 

A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.

AstraZeneca Oral PCSK9 Prospects Pumped After Phase IIb Win

 
• By 

The UK giant is forecasting peak sales of $5bn plus

Novo Scores Cardio Wins But Lilly Still Tipped To Take GLP-1 Crown

 

Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.