Aerovate's PAH drug fails Phase II, shares plummet

17 Jun 2024
firstwordpharma.com
Phase 2Clinical ResultClinical Trial Failure
Aerovate Therapeutics said its pulmonary arterial hypertension (PAH) treatment candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial. The results sent Aerovate's shares into a freefall, plunging over 90% in early trading on Monday.
The Phase IIb portion of the IMPAHCT trial aimed to assess three different doses of AV-101, a novel dry powder inhaled formulation of imatinib. The primary endpoint tested change in pulmonary vascular resistance (PVR) compared to placebo, but none of the doses showed a significant benefit on this measure, and there was no meaningful improvement on the secondary endpoint evaluating how far patients could walk in six minutes.
CEO Tim Noyes called the results "unexpected and disappointing" and said Aerovate would now focus on "transparently sharing these findings with investigators, patients and the PAH community."
AV-101 is dry powder inhaled formulation of the antiproliferative drug imatinib, designed specifically for the treatment of PAH. The drug targets cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries. By delivering the drug directly to the lungs through inhalation, Aerovate aimed for more of the drug to access diseased tissues while limiting systemic exposure.
As a result of the setback, the company is halting enrollment and shutting down the Phase III portion of IMPAHCT as well as the long-term extension study of AV-101. The drug appears to be its only programme, according to the company's website. As of mid-June, Aerovate reported approximately $100 million in cash, cash equivalents, and short-term investments.
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