KalVista Pharmaceuticals Reports Positive Results for KVD900 Phase 2 Demonstrating Statistically and Clinically Significant Responses Across All Endpoints as an Oral On-Demand Treatment for HAE Attacks
– Oral KVD900 Primary Endpoint Shows Only 15% Use of Rescue Medication in Patients with Hereditary Angioedema (HAE) –
– KVD900 Generally Safe and Well-Tolerated –
– Conference Call to Discuss Trial Results Today at
“We are very excited to share this positive data which shows that KVD900 is the first oral therapy to achieve clinical efficacy results comparable to current injectable therapies, while also demonstrating a promising safety and tolerability profile. The rapid onset of symptom relief and significant reduction in the use of rescue medication show that patients can confidently take KVD900 at the earliest signs of an attack and avoid the burden and discomfort of injections,” said
The KVD900 Phase 2 was a randomized, double-blind, placebo-controlled, crossover clinical trial evaluating the efficacy and safety of KVD900 as an on-demand treatment for hereditary angioedema (HAE) attacks. The trial completed 53 adult HAE patients from 25 clinical sites in
Topline Phase 2 Results
Attacks treated with KVD900 significantly reduced use of rescue (p=0.001), with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours.
- This efficacy benefit of KVD900 was maintained at 24 hours (p=0.0005).
- KVD900 significantly reduced time to onset of symptom relief (p=<0.0001) on a Patient Global Impression of Change scale (PGI-C), with a median time of 1.6 hours versus 9 hours for attacks treated with placebo.
- KVD900 treated attacks achieved symptom relief more quickly than placebo treated attacks (p<0.0001) when assessed using a composite Visual Analogue Scale (VAS) score.
- Within 12 hours of oral administration, KVD900 significantly increased the number of stabilized or improved attacks when assessed by a Patient Global Impression of Severity scale (PGI-S) or use of rescue (p<0.0001).
- Additional exploratory endpoints were also statistically significant and favored KVD900 treatment over placebo.
- There were no serious adverse events reported in the trial and no patients withdrew due to adverse events. In the open-label phase, 8 on-treatment drug-related treatment emergent adverse event (TEAE) were experienced by 5 patients. In the crossover phase of the trial, 3 on-treatment drug-related TEAEs were experienced by 3 patients (5.2%) following administration of KVD900, and 2 on-treatment drug-related TEAEs were experienced by 2 patients (3.6%) following administration of placebo.
“Today’s data show that KVD900 halts HAE attack progression and also provides rapid relief by shortening the time to symptom resolution,” said Dr. Emel Aygören-Pürsün, Principal Investigator for the KVD900 Phase 2 Clinical Trial and Head of the HAE Center at the University Hospital Frankfurt. “The results are highly encouraging. For patients, easy and efficacious oral on-demand treatment of attacks is now within reach."
The Company will post a presentation with data from the Phase 2 clinical trial of KVD900 on the investors section of the company website at www.kalvista.com. The Company plans to present the full data for the KVD900 Phase 2 study at a future medical meeting.
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