View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 7, 2022

KalVista commences Phase III trial of oral hereditary angioedema treatment

The company plans to report results from the clinical trial of KVD900 in the second half of next year.

KalVista Pharmaceuticals has commenced the Phase III KONFIDENT clinical trial of oral KVD900 for the treatment of hereditary angioedema (HAE) attacks.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

KVD900 is said to be the first potential oral, on-demand therapy for HAE.

It is designed to offer a significant improvement for HAE attacks versus the present on-demand therapies administered by injection.

The global, placebo-controlled, double-blind, crossover trial will analyse the safety and efficacy of two dose levels of KVD900 versus placebo to treat acute HAE attacks in adolescents and adult subjects. 

Being carried out at nearly 60 study centres in 20 countries, the trial anticipates to enrol around 84 adolescents and adults with HAE. 

In a double-blinded, randomised series, these subjects will complete treatment of three attacks: one each with 300mg KVD900, 600mg KVD900 and placebo. 

The time to the commencement of relief in symptoms, as assessed on a Patient Global Impression of Change (PGI-C) scale will be the trial’s primary endpoint.

Analysing other measures of patient response and attack progression as well as safety will be other endpoints of the study. 

The company expects to report results from the trial in the second half of next year.

KalVista CEO Andrew Crockett said: “We believe that KVD900 has the potential to transform the treatment paradigm for HAE patients experiencing acute attacks, whether they primarily treat with on-demand medications or use long-term prophylaxis. 

“Based upon the results of our Phase II study released last year, we expect that KVD900 can provide patients with symptom relief as rapidly as existing therapies, but with an oral tablet that will allow earlier treatment of all patient-recognised HAE attacks.”

In September last year, the US Food and Drug Administration lifted the clinical hold placed on KalVista’s Phase II KOMPLETE trial of KVD824 as oral prophylactic for HAE.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena