Kalvista Pharmaceuticals Inc.’s positive phase III news Feb. 13 with sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), sparked Wall Street speculation about competitor Pharvaris BV with deucrictibant, a bradykinin B2 receptor antagonist.
Kalvista Pharmaceuticals Inc. is promising to “change the paradigm” in the treatment of hereditary angioedema, after announcing positive phase III data for its oral on-demand kallikrein inhibitor sebetralstat. Rather than waiting four to five hours to self-administer therapy, as is the case for approved injectable on-demand therapies, there was a median time to dosing of 10 minutes after the start of an attack in the ongoing open label extension trial and a median time to dosing of 41 minutes in the 136-patient placebo-controlled phase 3 trial.
Dysregulation of the kallikrein-kinin system (KKS) is involved in hereditary angioedema (HA) pathophysiology; thus, the inhibition of factor XIIa (FXIIa), a central mediator of angioedema and initiator of KKS, is a therapeutic strategy to prevent and treat HA attacks.
Biocryst Pharmaceuticals Inc.’s unveiling of real-world data Feb. 24 with its approved Orladeyo (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) brought more attention to the space, due to yield findings from would-be competitors in the near term.
Biocryst Pharmaceuticals Inc. caught some industry observers by surprise early in 2022 when it upped its peak sales estimate for Orladeyo (berotralstat), its oral therapy for prevention of hereditary angioedema attacks, from $500 million to $1 billion. But blockbuster status appears more attainable following the latest setback from a potential competitor, as safety concerns prompted Kalvista Pharmaceuticals Inc. management to ax its phase II study testing KVD-824 in prevention of HAE attacks.
Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings.
Kalvista Pharmaceuticals Inc. made big news in October 2017 by way of its handsome deal with Merck & Co. Inc. to advance KVD-001, an intravitreal injection candidate to treat diabetic macular edema (DME).