Pharvaris is looking for redemption for its leading hereditary angioedema (HAE) drug hopeful PHA121 in the form of a six-month animal toxicity trial aimed at assuaging concerns over the med’s safety.
In August last year, Pharvaris’ shares plummeted when the FDA slapped multiple clinical holds on phase 1 trials for the company’s HAE asset.
A the time, the European biotech was mum on exactly what caused the holds, but in its business update today during the J.P. Morgan Healthcare Conference, it looks like safety was the concern.
Pharvaris said in its company update Monday that it will “conduct a 26-week rodent toxicology study” with the specific aim being to “resolve the clinical holds in the U.S.” Specifics on what toxicities the company is looking for were not provided.
Pharvaris adds that the protocol for this nonclinical study “has been submitted to the FDA for review.”
The drug is not entirely new and Pharvaris is essentially trying to tinker and renovate an existing drug. Modeled after Jerini's HAE med Firazyr, Pharvaris hopes its small-molecule-based meds can act faster than the competition.