A phase 3 trial of Pharvaris’ deucrictibant has hit its primary endpoint, positioning the biotech to file for approval of a challenger to KalVista Pharmaceuticals’ Ekterly in a rare genetic disease.
Investigators randomized 134 people with hereditary angioedema (HAE) to receive deucrictibant or placebo. Participants took oral, immediate-release capsules of bradykinin B2 receptor antagonist deucrictibant for the on-demand treatment of episodes of swelling and related symptoms that affect people with HAE.
Patients on deucrictibant experienced symptom relief 1.28 hours after taking the medicine, compared to more than 12 hours for their counterparts on placebo. The result met the trial’s primary endpoint and the base case of Guggenheim Securities analysts.
In a November note to investors, the analysts said their base case was that deucrictibant would provide symptom relief in 1.2 to 2 hours. While the primary endpoint fell slightly short of the analysts’ 1.1-hour bull case, the available data are toward the upper end of their expectations for the readout.
Pharvaris CEO Berndt Modig said on a call with investors Wednesday that the data position deucrictibant to provide the fastest symptom relief and achieve complete attack resolution, “offering beginning-to-end control of HAE attack treatment.”
Time to substantial symptom relief by PGI-S, a measure of disease severity, was 2.41 hours on the study drug. Guggenheim analysts said any time under 2.5 hours would meet their bull case. Time to complete symptom resolution was 11.95 hours, putting the result in the middle of the analysts’ base-case range. A single deucrictibant dose resolved 83% of attacks. The result fell just short of the 86% bull-case threshold.
The analysts assigned a 60% probability of success to their base case and predicted the company’s stock would land in the $24 to $30 range in that scenario. Pharvaris’ share price increased 10% to $26.50 in premarket trading.
No participants had treatment-related serious adverse events nor discontinued deucrictibant because of treatment-emergent adverse events. Pharvaris said the safety and tolerability profile to date is consistent with completed and ongoing studies of deucrictibant for the treatment of HAE attacks.
Pharvaris plans to file for approval of deucrictibant in the first half of 2026. If approved, deucrictibant will give HAE patients an alternative to KalVista’s Ekterly, an existing oral HAE attack treatment. Patients taking Ekterly in a phase 3 trial experienced symptom relief within 1.61 hours. Patients on placebo had symptom relief in 6.72 hours in the Ekterly trial.
While cross-trial comparisons can be unreliable, the available data suggest deucrictibant may have an edge in some areas. Modig named time to complete attack resolution as an area in which deucrictibant could be differentiated, telling investors that the endpoint is important to patients because it determines when they can resume normal life.
Guggenheim analysts predicted in October that deucrictibant could achieve peak penetration of up to 66% in the on-demand setting if the phase 3 readout replicated the advantage over Ekterly that the drug candidate appeared to have in a midstage study. The analysts estimated peak annual revenue potential of up to $800 million.
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