The study drug, PHVS416, is an investigational* drug designed to stop an HAE attack before it becomes too severe. The study drug is anticipated to work by blocking a compound, called bradykinin, that is responsible for triggering swelling in people with HAE.
*Investigational means that the study drug has not been approved by the regulatory authority in any country to be used for attacks caused by HAE.
Researchers developed the study drug in the form of soft capsules taken by mouth, which are expected to be a more convenient alternative to an injection into a vein or under the skin for resolving HAE attacks.
If the study drug capsules you take have no effect, you will be allowed to use an approved HAE medication to resolve the HAE attack.
The RAPIDe-1 will last up to approximately 7 months and will be divided into 4 periods: The Screening period (up to 4 weeks), Non-Attack period (1 study location visit), Home Dosing period (up to 24 weeks), and End-of-Study period (1 remote study visit by phone).
There is no cost to clinical study participants. All study related medications and treatment visits are covered by the Study Sponsor. Travel related costs may be reimbursed.
Yes, you must be diagnosed with HAE (type I or II) and have had at least 3 HAE attacks in the last 4 months, or at least 2 HAE attacks in the last 2 months.
Clinical research studies help scientists and doctors explore whether a medical therapy is safe and effective for people. Clinical research studies are important because they help identify which medical approaches work best for certain illnesses in certain groups of people. There is no guarantee that the study drug will improve your HAE attacks, but what researchers learn from the RAPIDe-1 clinical research study may lead to better medications for HAE in the future.
Pharvaris is the RAPIDe-1 clinical research study Sponsor. Pharvaris is a clinical-stage company focused on bringing an oral bradykinin B2 receptor antagonist to HAE patients. By targeting this clinically proven therapeutic target with novel small molecules, Pharvaris is progressing new alternatives to injected therapies for all sub-types of hereditary angioedema (HAE) and other B2 receptor-mediated indications.
Study tests and procedures help the study doctor monitor your health and the effects of the study drug – including: vital signs, electrocardiogram (ECG), blood tests, urine tests, symptoms and medication reporting.
HAE is a rare genetic disease that causes attacks of pain and/or swelling, often in the hands, feet, stomach, back, intestines, face, throat, or tongue. Attacks in the stomach area can be extremely painful and cause nausea and vomiting. As you probably know, HAE attacks often occur without warning.
HAE is usually caused by a mutation in the gene that makes instructions for production of a blood protein called C1-inhibitor. The gene mutation causes little or no C1-inhibitor protein to be produced, which leads to an imbalance in the blood. This imbalance allows for too much of a compound called bradykinin to build up, and it is this compound that causes the symptoms of an HAE attack, such as pain and swelling. The study drug in the RAPIDe-1 clinical research study is designed to stop bradykinin from fueling the symptoms of HAE.
You should contact a local study location for more information on the RAPIDe-1 clinical research study and contact your HCP.