A midstage test of KalVista Pharmaceuticals’ hereditary angioedema (HAE) hopeful KVD824 has been slapped with an FDA clinical hold as it demands more preclinical data and changes to its protocol.
The U.K.-U.S. biotech said in a statement that: “An Investigational New Drug Application was submitted earlier in 2021 for a phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks [a severe swelling of the skin].
“The FDA letter requests further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned phase 2 trial. Refinements were also proposed to the intended KVD824 phase 2 study protocol. No new studies were requested nor was it suggested that new data be generated to initiate the phase 2 trial.”
It gave no more details as to the FDA’s demands but did say that the planned trial of KVD824 will likely now not start this quarter.
RELATED: KalVista's rival to Takeda's Firazyr aces trial, sending stock up 200%
The news was so different two months ago: KalVista’s oral plasma kallikrein inhibitor scored a key trial win when it reduced the use of rescue medication in patients suffering swelling attacks associated with a rare disease.
The phase 2 results, posted in February, boosted KalVista’s prospects of establishing KVD900 as an alternative to injectable treatments such as Takeda’s Firazyr and Pharming’s Ruconest. Its shares rocketed up 200% on those data.
The biotech’s CEO, Andrew Crockett, was keen to stress that this “does not impact our activities or expectations with regard to KVD900 […] for which we continue to prepare for an End of phase 2 FDA meeting and commencement of our phase 3 efficacy trial.” The biotech's shares were down 11% premarket on the news.