KalVista Pharmaceuticals will bring on Paul Audhya, M.D., as chief medical officer as the Cambridge, Massachusetts-based biotech works to get a clinical trial for its hereditary angioedema franchise back on track.
Audhya arrives at the company just under two weeks after the FDA placed a clinical hold on KVD824 while new data are collected for review. KalVista submitted a new drug application for the oral therapy earlier in 2021 to conduct a phase 2 clinical trial.
The new CMO brings with him experience in global medical affairs, drug development and international product launches. He previously served as senior vice president, global medical affairs for Arena Pharmaceuticals. He has also held roles at Vertex Pharmaceuticals, Amgen, Bristol Myers Squibb and others.
“The move to efficacious and safe oral treatments represents a critical advancement for HAE patients around the world, and the data KalVista has shown makes them unique as the only company developing multiple oral drugs for attack management,” Audhya said in a statement.
With the HAE franchise moving closer to commercialization, KalVista CEO Andrew Crockett said the company will be undergoing strategic growth and plans to add “individuals with deep experience.”
Prior to the FDA action on KVD824, KalVista was riding high after scoring a phase 2 trial win with another drug, KVD900, which was found to reduce the use of rescue medication in patients suffering swelling attacks associated with a rare disease. The company is hoping the oral plasma kallikrein inhibitor KVD900 can provide patients with an alternative to injectable treatments such as Takeda’s Firazyr and Pharming’s Ruconest.