Aerovate Therapeutics has published data from a Phase 1 study of its AV-101 dry powder imatinib showing that the inhaled formulation resulted in significantly lower systemic exposure compared to oral imatinib. The company announced the initiation of the IMPAHCT trial Phase 2b/3 of AV-101 in patients with pulmonary arterial hypertension (PAH) in December 2021. The company said that the first data from that trial are expected in late 2023 or early 2024.
The Phase 1 study enrolled 40 subjects in the SAD portion of the trial and evaluated single doses of AV-101 at 1 mg, 3 mg, 10 mg, 30 mg, and 90 mg or placebo; an additional 8 subjects received a 400 mg dose of oral imatinib. The MAD portion of the study enrolled 34 patients who got 10 mg, 30 mg, or 90 mg doses of AV-101 or placebo twice daily over 7 days.
Aerovate Chief Medical Officer Hunter Gillies commented, “Our objective was direct delivery of imatinib to the lung using lower doses to limit systemic exposure, and our Phase 1 findings demonstrate that inhaled AV-101 limited systemic exposure compared to oral imatinib and was generally well tolerated. There continues to be a high unmet need for new medications to treat PAH, and these results reaffirm our confidence in AV-101 as a potential option for people living with the condition. We look forward to further investigation of AV-101 in our Phase 2b/Phase 3 trial.”
Read the Aerovate Therapeutics press release.
