FDA Lifts Clinical Hold on Pharvaris’ HAE Treatment

The FDA has cleared Pharvaris’ investigational drug for clinical trials. This is great news for patients with hereditary angioedema (HAE), a rare and potentially life-threatening condition. The drug has been on hold since last year due to safety concerns, but after extensive review, the FDA has lifted the clinical hold, allowing the company to move forward with its development.

FDA Clears Pharvaris’ HAE Treatment for Clinical Trials

Pharvaris is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drugs for the treatment of HAE and other bradykinin-mediated diseases. The company’s lead drug candidate, PHVS416, is a potent, selective, and reversible oral small molecule inhibitor of the kallikrein-kinin system. The kallikrein-kinin system is a crucial mediator of inflammation and is activated in HAE patients, leading to the hallmark symptoms of the disease, including edema, pain, and swelling.

In December 2020, the FDA placed a clinical hold on Pharvaris’ investigational new drug application for PHVS416 due to safety concerns. Specifically, the FDA was concerned about the potential for drug-induced liver injury (DILI). Pharvaris immediately initiated a comprehensive investigation and provided detailed responses to the FDA’s questions. After extensive review, the FDA has now lifted the clinical hold, allowing Pharvaris to move forward with the clinical development of PHVS416.

Pharvaris’ Investigational Drug Gets Green Light from FDA

The FDA’s decision to lift the clinical hold on PHVS416 is a significant milestone for Pharvaris and for HAE patients. The company can now resume its Phase 2 clinical trial of PHVS416, which was paused when the clinical hold was implemented. The trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PHVS416 in HAE patients.

Pharvaris’ ultimate goal is to provide HAE patients with a safe, effective, and convenient oral treatment for their disease. The company believes that PHVS416 has the potential to transform the treatment landscape for HAE and is committed to advancing its development as quickly and safely as possible. With the clinical hold lifted, Pharvaris is well-positioned to continue its mission and bring relief to HAE patients worldwide.

The FDA’s decision to lift the clinical hold on Pharvaris’ HAE treatment is welcome news for patients and the biopharmaceutical industry. It highlights the importance of rigorous safety evaluations and the critical role of clinical trials in advancing new treatments for rare diseases. Pharvaris’ commitment to patient safety and its dedication to finding new therapies for HAE patients is commendable, and we look forward to seeing the results of the upcoming clinical trial.