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Aerovate Therapeutics’ AVTE shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT study evaluating its lead candidate, AV-101, in adults with pulmonary arterial hypertension (PAH).
The mid to late-stage IMPAHCT study evaluated the efficacy, safety and tolerability of three different doses of AV-101 compared with placebo.
Per the data readout from the phase IIb portion of the IMPAHCT study, AV-101, a novel dry powder inhaled formulation of imatinib, failed to meet the primary endpoint of change in pulmonary vascular resistance for any of the studied doses.
Moreover, treatment with the candidate did not demonstrate any meaningful improvements in the study’s secondary endpoint of change in the six-minute walk distance.
The company has further reviewed data from several additional secondary endpoints of the phase IIb portion of the IMPAHCT study and found no meaningful improvements. Based on such poor outcomes, AVTE has decided, in agreement with the independent study advisory committee, to halt enrollment and shut down both the phase III portion of the study and the associated long-term extension study.
Year to date, shares of Aerovate have plunged 92.7% compared with the industry’s 6.4% decline.
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AV-101 was, however, well-tolerated across all dose groups with a favorable safety profile.
Aerovate plans to engage closely with the IMPAHCT study advisory committee and the PAH community in the coming weeks to discuss the data and its implications. The company intends to release the full data from the phase IIb portion at a later, yet-to-be-determined date.
PAH is a devastating cardiopulmonary disease impacting approximately 70,000 people in the United States and EU.
The IMPAHCT study failure news is particularly detrimental to the stock as AV-101 is the company’s only pipeline candidate. This means that there is no other candidate currently under development to which Aerovate can shift its focus.
As of the middle of June 2024, Aerovate reported that it has approximately $100 million in cash, cash equivalents and short-term investments.
The company also does not have any existing collaborations with other biotech firms from where it can generate funds. On the contrary, the failure of the AV-101 study is expected to make it difficult for Aerovate to find potential collaborators.
Under such circumstances, the company is likely to seek buyout offers or seize operations altogether.