Aerovate slashes workforce after failed Phase IIb trial

02 Jul 2024
www.pharmaceutical-technology.com
Phase 2Drug ApprovalAcquisitionPhase 3
Pulmonary hypertension is high blood pressure in the blood vessels that supply the lungs. Credit: Andrew Angelov via Shutterstock.
Pulmonary hypertensionis slashing its workforce by 78%, two weeks after the company announced a Phase IIb trial failure of its pulmonary arterial hypertension (PAH) drug AV-101.
Aerovate Therapeuticsed biotech announced the downsizing in an SEC filing where Aerovate said it expects to incur costs of aboupulmonary arterial hypertension (PAH) costsAV-101xpected to be incurred in the third and fourth quarters of 2024. The company also added that it expects all of its workforce to be cut in the coming months.
On 17 June, Aerovate shut down its Phase II/III IMPAHCT trial (NCT05036135) afteAerovatease IIb section did not meet its primary endpoint for improvement in PAH compared to placebo for any of the studied doses. AV-101—an inhaled version of the drug imatinib—also failed to show meaningful improvements in the secondary endpoint of change in six minute walk distance. The Phase III and long-term extension arms (NCT05557942) were consequently stopped, with Aerovate’s stock price plummeting over 90% following the announcement.
PAH is a conAerovateharacterised by high blood pressure, leading to strain on the heart and reduced oxygenation. Competition in the PAH market has increased PAHr the past year, with MSD’s Winrevair (sotatercept-csrk) and Johnson & Johnson’s Opsynvi—imatinibation of drugs Adcirca (tadalafil) and Opsumit (macitentan)—both gaining US Food and Drug Administration (FDA) approval in March 2024.Aerovate
PAHtinib is a small molecule tyrosine kinase inhibitor (TKI) that blocks signalling by binding to the ATP-binding pocket necessary for receptor activation. Marketed by Novartis as GlMSDec, imatinib is available as a generJohnson & Johnsonnt.OpsynviOpsumit(macitentan)—bothUS Food and Drug Administration (FDA)
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Oral imatinib has been shown to be effective, but poorly tolerated in patients with PAH. Therefore, AV-101, a dry powder inhaled formulation of imatinib, was developed to avoid systemic exposure by delivering the therapy directly to the lungs.
EMAovate launSanofiackDupixent withCOPD.6m in Series A funding round led by Sofinnova Investments. The money was meant to advance trials of AV-101, which was its lead and only clinical candidate.
According to a report on GlobalData’s Pharma Intelligence Center, PAH market sales will be worth $7.4bn in the seven major markets (US, UK, France, Germany, Italy, Spain, and Japan) in 2029.
Globaimatinib the parent company of Pharmaceutical Technology.PAHAV-101imatinib
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