Clinical stage pharmaceutical company KalVista Pharmaceuticals (“KalVista”) saw positive data from a Phase 2 clinical trial evaluating its experimental therapy KVD900, shared MedCity News. The Phase 2 trial was exploring KVD900 as a treatment option for patients with hereditary angioedema (HAE). Currently, most FDA-approved drugs associated with HAE are injectable. KalVista’s option, which is orally administered, may offer an easier and more effective treatment option.
After sharing data in a separate press release, it became clear that KVD900 offered significant benefits over a placebo. Additionally, when compared to the current standard-of-care (injectables), KVD900 offered comparable benefits. In the study, which enrolled 68 patients, only 15% of patients needed additional care after 12 hours. Many patients also experienced relief from symptoms associated with HAE attacks in a median 1.6 hours, 7.4 hours less than those taking the placebo. Considering the median time for injectable treatment to kick in is around 1.4 hours, KVD900 offers similar benefits without the additional pain of injectable therapy. The press release also shares that the drug was relatively safe and well-tolerated, with no serious side effects or adverse reactions occurring.
KVD900 works by inhibiting or blocking plasma kallikrein, which helps to regulate and modulate inflammatory responses. Currently, KalVista hopes to plan an additional Phase 3 clinical trial around KVD900 following a meeting with the FDA. Additionally, the company is also developing KVD824, another potential HAE therapy.
Hereditary angioedema (HAE) is inherited in an autosomal dominant pattern, meaning only one mutated or defective copy is needed to cause this condition. The mutation causes C1-inhibitor, a blood protein, to not work well. Since this protein normally plays a role in coagulation and inflammation, multiple health issues may arise when it is not working well. Excessive bradykinin, a peptide, is generated, causing fluid to leak into body tissues. As a result, patients with HAE experience swelling caused by excess fluid in bodily tissue. This swelling occurs in recurrent, but unexplained, “attacks.” Although the swelling can be caused by triggers like alcohol, illness, surgery, or stress, no known cause may exist. While HAE affects both males and females equally, females are often more symptomatic due to hormonal changes.
If occurring in the extremities, HAE can cause hands and feet, arms, and legs to swell to 2x their size. It can prompt nausea and vomiting, as well as abdominal pain and distention, if occurring in the intestines. If the swelling occurs on the face, the eyes might swell shut. People also become unrecognizable. Finally, HAE can be dangerous if occurring in or around the throat. This could make it difficult to breathe and thus become life-threatening. Patients with HAE experiencing breathing difficulties should see their doctors immediately.