What is the mechanism of action of this treatment?

Hereditary Angioedema (HAE) is commonly treated with medications that target the bradykinin pathway, as bradykinin is a key mediator of the swelling episodes characteristic of HAE. Kallikrein inhibitors, such as KVD900, work by inhibiting plasma kallikrein, an enzyme that facilitates the production of bradykinin. By reducing bradykinin levels, these inhibitors help prevent and manage acute swelling attacks. This mechanism is crucial for HAE patients because it directly addresses the underlying cause of their symptoms, providing more effective and targeted relief compared to broader treatments.

What side effects are associated with this type of intervention?

Common treatments for Hereditary Angioedema (HAE) include kallikrein inhibitors, C1 esterase inhibitors, and bradykinin receptor antagonists. Known side effects of these treatments can include injection site reactions, headache, dizziness, and nausea. Kallikrein inhibitors, like the one being studied in the KVD900 trial, may also cause gastrointestinal issues and hypersensitivity reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Hereditary Angioedema (HAE), including C1 esterase inhibitors (e.g., Berinert, Cinryze), bradykinin receptor antagonists (e.g., Icatibant), and kallikrein inhibitors (e.g., Ecallantide). KVD900, being a kallikrein inhibitor, is similar to Ecallantide, which is used to treat acute HAE attacks by inhibiting plasma kallikrein, thereby reducing the production of bradykinin, a key mediator in HAE.

What other types of research exist?

Promising novel alternatives to KVD900 for Hereditary Angioedema patients include Lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, and Berotralstat, an oral plasma kallikrein inhibitor. Both have shown efficacy in reducing HAE attack frequency in clinical trials.

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KVD900 for Hereditary Angioedema

Phase 3

Recruiting

Research Sponsored by KalVista Pharmaceuticals, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a medication called KVD900 in teenagers with a rare condition that causes sudden swelling. The goal is to see how the medication behaves in their bodies and if it can help manage their symptoms.

Who is the study for?

Adolescents aged 12-17 with Hereditary Angioedema (HAE) types I or II can join this trial if they're already in the KVD900-302 study. They must be willing to provide samples, complete forms and diaries, and have consent from a legal representative.

What is being tested?

The trial is testing how the body processes KVD900, a drug for HAE. It's specifically looking at its pharmacokinetics—how the drug is absorbed, distributed, metabolized, and excreted—in adolescents.

What are the potential side effects?

While specific side effects of KVD900 are not listed here, common ones may include reactions at the injection site, nausea or headaches. More serious risks could involve allergic reactions or issues related to bleeding disorders.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding disorder or am taking blood-thinning medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 136 Patients • NCT05259917

HEADACHE

ANISOCORIA

NAUSEA

VOMITING

HEREDITARY ANGIOEDEMA

DIZZINESS

100%

80%

60%

40%

20%

Study treatment Arm

KVD900 600 mg

Placebo

KVD900 300 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: KVD900 600 mgExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KVD900 600 mg

2022

Completed Phase 3

~140

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hereditary Angioedema (HAE) is commonly treated with medications that target the bradykinin pathway, as bradykinin is a key mediator of the swelling episodes characteristic of HAE. Kallikrein inhibitors, such as KVD900, work by inhibiting plasma kallikrein, an enzyme that facilitates the production of bradykinin. By reducing bradykinin levels, these inhibitors help prevent and manage acute swelling attacks. This mechanism is crucial for HAE patients because it directly addresses the underlying cause of their symptoms, providing more effective and targeted relief compared to broader treatments.

Ecallantide for treatment of acute attacks of acquired C1 esterase inhibitor deficiency.