A near-Komplete disaster for Kalvista

The bad news for Kalvista investors is that one of the group's hereditary angioedema projects has been canned. The good news is that it is not the more advanced sebetralstat. KVD824 was in the phase 2 Komplete trial, which was terminated after seven patients across all three dose groups had grade 3 or 4 liver enzyme elevations, the company said today. Backing away here is a logical move: there is no room for a potentially unsafe therapy in HAE, a disease that boasts several good options already, as well as a packed pipeline. Kalvista’s focus now rests on sebetralstat; the phase 3 Konfident study is due to read out towards the end of 2023. But sebetralstat shares a mechanism with ’824 – both are oral kallikrein inhibitors – and, despite the company’s insistence that sebetralstat’s safety is unaffected, fears for this asset are surely behind the 53% plunge in Kalvista’s shares this morning. Stifel analysts reject this notion, stating that ’824 was dosed higher than sebetralstat and that the 900mg BID dose in Komplete “was always a risk”. They give sebetralstat a 75% probability of success, while 2028 sellside consensus sits at a punchy $508m, according to Evaluate Pharma.

Kalvista's hereditary angioedema pipeline
Project Description Setting Trial details
Sebetralstat (KVD900) Oral plasma kallikrein inhibitor Acute Ph3 Konfident data due H2 2023; NDA planned for 2024
KVD824 Oral plasma kallikrein inhibitor Prophylaxis Ph2 Komplete trial terminated Oct 2022
Unnamed Oral factor XIIa inhibitor  Prophylaxis Preclinical; IND planned for 2023
Source: Evaluate Pharma & clinicaltrials.gov.

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