Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Drug: KVD900
KVD900 · 6 trials · 1 indication
A TEAE was defined as an adverse event (AE) that met any of the following conditions: (1) began on or after the first dose of IMP, (2) began before the first dose of IMP and increased in severity on or after first dose, (3) was completely missing a start date and the stop date, (4) was completely missing a start date and the stop date was on or after the first dose of IMP. An on-treatment TEAE was defined as any TEAE occurring within 3 days of IMP administration. A treatment-related TEAE was an AE considered related to the IMP by the investigator. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation, resulted in significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event (based upon medical and scientific judgment).
The analysis of time to the beginning of symptom relief defined as at least "a little better" (2 time points in a row) on the PGI-C within 12 hours of the first IMP administration using the Gehan score transformation test for Full Analysis Set (FAS). Attacks were treated as right-censored at 12 hours if they did not achieve beginning of symptom relief defined by PGI-C as at least "a little better" (2 time points in a row) or received conventional attack treatment prior to time-to-event within 12 hours of the first IMP administration. When an endpoint result was non-evaluable (NE) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
| Arm | Type | Description |
|---|---|---|
| 150 mg Dose Group | OTHER | Patients will take a single 150 mg dose of KVD900. |
| 300 mg Dose Group | OTHER | Patients will take a single 300 mg dose of KVD900. |
| 600 mg Dose Group | OTHER | Patients will take a single 600 mg dose of KVD900. |
| KVD900 600 mg | EXPERIMENTAL | - |
| KVD900 300 mg | EXPERIMENTAL | - |
| Experimental: KVD900 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Part 1 | EXPERIMENTAL | Subjects received a single dose of 600 mg KVD900. |
| Part 2 - Sequence 1: 600 mg KVD900, Then Placebo | EXPERIMENTAL | Subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack. |
| Part 2 - Sequence 2: Placebo, Then 600 mg KVD900 | EXPERIMENTAL | Subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack. |
| Single Ascending Dose - 5 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 10 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 20 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 40 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 80 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 160 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 300 mg | EXPERIMENTAL | - |
| Single Ascending Dose - 600 mg | EXPERIMENTAL | - |
| Formulation Screen | EXPERIMENTAL | - |
| Food Effect | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| KVD900 150 mg | DRUG | KVD900 Tablet 150 mg (2 x 75 mg) |
| KVD900 300 mg | DRUG | KVD900 Tablet 300 mg (1 x 300 mg) |
| KVD900 600 mg | DRUG | KVD900 Tablet 600 mg (2 x 300 mg) |
| Drug: KVD900 300 mg | DRUG | KVD900 Tablet 300 mg |
| Placebo | DRUG | Placebo to KVD900 Tablet |
| KVD900 | DRUG | KVD900 tablet 600 mg |
| Placebo to KVD900 | DRUG | Placebo |
Inclusion Criteria: 1. Male or female patients 2 to 11 years of age. 2. Confirmed diagnosis of HAE Type I or II. 3. For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening. 4. Caregiver, as assessed by the Investigator, must be able to ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | Deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
KVD900 is an investigational oral small molecule developed as an on-demand treatment for angioedema attacks in patients with hereditary angioedema (HAE) type I or II. It is being studied in adolescent, adult, and pediatric patients, including a Phase 3 trial in children aged 2 to 11.
KVD900 targets plasma kallikrein, a protein involved in the pathway that drives swelling during hereditary angioedema attacks. By inhibiting plasma kallikrein, KVD900 is designed to interrupt the cascade that produces bradykinin, the mediator responsible for the vascular leakage and swelling characteristic of HAE attacks.
KVD900 is being developed by KalVista Pharmaceuticals, Inc., which trades under the ticker KALV. The company is advancing the drug as an oral on-demand therapy for hereditary angioedema attacks across adolescent, adult, and pediatric patient populations.
KVD900 is in Phase 3 development. Six Phase 3 trials have been completed, including the pivotal crossover efficacy trial, a long-term open-label extension, an adolescent pharmacokinetic subtrial, and a pediatric trial in patients aged 2 to 11. No trials are currently active.
KVD900 has been studied in six completed Phase 3 trials, including NCT05259917, a crossover efficacy and safety trial in adolescents and adults; NCT05505916, a long-term open-label extension; NCT05511922, an adolescent pharmacokinetic subtrial; and NCT06467084, an open-label pediatric trial in children aged 2 to 11. Total enrollment across these trials was 496 patients.
Yes, KVD900 is also known as sebetralstat. The names KVD900 150 mg, KVD900 300 mg, and KVD900 600 mg refer to the different dose strengths studied in clinical trials. All refer to the same investigational oral plasma kallikrein inhibitor being developed by KalVista Pharmaceuticals for hereditary angioedema.