Aerami Therapeutics said that it has initiated dosing in a Phase 1 clinical trial of its AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH). According to the study description on clinicaltrials.gov, the SAD/MAD trial is expected to enroll 78 healthy volunteers and is expected to evaluate doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg in the first part of the study.
AER-901 is delivered via the Fox handheld vibrating mesh nebulizer from Vectura, which was developing the imatinib inhalation solution itself prior to its its transition into an inhalation CDMO in 2019. Aerami announced that it had partnered with Vectura on development of the nebulized imatinib in June 2020
Earlier this year, Aerami announced that Hangzhou Chance Pharmaceuticals had acquired the rights to AER-901 for China, Hong Kong, Macau and Taiwan. Aerami now reports that Chance has recently requested a pre-IND meeting with the Center for Drug Evaluation.
Aerami CEO Steve Thornton commented, “We are pleased to announce that the dosing of subjects in our Phase 1 trial is ongoing and that we expect to have results available later this year, which, combined with the completion of our long-term toxicology program, will allow us to quickly move into our planned Phase 2/3 trials targeted for early in 2022. We believe that AER-901 might, for the first time, provide the opportunity to modify the course of this insidious disease, and offer another important therapeutic option for patients with limited treatment options.”
Aerami President Timm Crowder said, “By delivering AER-901, Aerami’s proprietary inhaled imatinib, directly to the site of the disease, we believe it has the potential to significantly reduce the dose necessary to achieve therapeutic benefit, thereby avoiding the adverse events seen with oral imatinib. Our nebulized formulation and delivery system has the potential to improve efficacy through deeper lung penetration and better drug uptake while reducing the potential for side effects like cough, which is commonly associated with other inhaled technologies such as dry powder formulations.”
Read the Aerami press release.
