our clinical trials
Pharvaris aims to bring better oral options to meet the needs of people with HAE for on-demand and prophylactic treatment. We are developing novel, potent and selective B2-receptor antagonist small molecules for the treatment of all sub-types of HAE.
HAE CHAPTER-1
Oral prophylactic treatment study
- For whom – people diagnosed with hereditary angioedema (HAE).
- Purpose – to evaluate PHVS416 in preventing HAE attacks.
- Approach – soft capsules taken orally to prevent HAE attacks
For more information, visit haechapter-1.com or https://clinicaltrials.gov/show/NCT05047185.
RAPIDe-2
Extension study of oral on-demand treatment
- For whom – people diagnosed with hereditary angioedema (HAE) who participated in RAPIDe-1
- Purpose – To further assess safety and efficacy of PHVS416 is in relieving symptoms associated with HAE attacks with long-term dosing.
- Approach – soft capsules taken orally to prevent HAE attacks
For more information, visit https://clinicaltrials.gov/ct2/show/NCT05396105
RAPIDe-1
Oral on-demand treatment study
- For whom – people diagnosed with hereditary angioedema (HAE).
- Purpose – To find out how effective PHVS416 is in relieving symptoms associated with HAE attacks.
- Approach – soft capsules taken orally to prevent HAE attacks
For more information, visit https://hae-rapide.com/, https://hae-rapide.us/ or https://clinicaltrials.gov/ct2/show/NCT04618211
click here to read our Expanded Access Policy
Pharvaris Expanded Access Policy
Pharvaris is committed to serving patients’ health needs by developing safe and effective therapies and making them available for use as quickly as possible. We believe that controlled clinical trials provide the best path for Pharvaris to generate the safety and efficacy information needed to obtain regulatory approval so that we can make our medicines available to all patients.
Pharvaris always seeks to provide the quickest and broadest access to its medicines, balancing benefit and risk to all patients. We support the principle of expanded-access programs consistent with the best standards for safe and effective use of an investigational therapy, as well as our ability to logistically provide a product. Pharvaris will consider requests for expanded access from qualified physicians, balancing multiple factors.
When evaluating potential use of an investigational therapy, we will consider several factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines including both patient and scientific perspectives. Eligibility requirements include but are not limited to:
- Sufficient scientific evidence to support both the safety and the efficacy of the compound’s mechanism for this indication
- A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
- Sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information
- Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication, which could affect future patient access
The evaluation of these, and other, questions may require additional investigation or interaction with the requesting physician, other clinical investigators, or regulatory authorities. Favorable answers alone provide no guarantee that Pharvaris will be able to provide pre-approval access to an experimental medicine.
Requests for access to investigational therapies must be made by a qualified and licensed physician to Pharvaris () and will be evaluated by a core team. Pharvaris anticipates it will acknowledge receipt of such requests within five business days after receipt of an inquiry.
Pharvaris may revise this policy at any time.