Inhaled drug developer Aerami Therapeutics has announced that it will go public through a merger with a special purpose acquisition company (SPAC) called FoxWayne Enterprises Acquisition Corp., and the resulting company’s common stock will be listed on the Nasdaq Capital Market. According to Aerami, the proceeds from the merger will be used for further development of the company’s AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), with a Phase 2/3 trial expected to begin next year.
In June 2020, Aerami announced that it had partnered with CDMO Vectura on development of the nebulized imatinib for the treatment of PAH. In February 2021, Hangzhou Chance Pharmaceuticals acquired Chinese rights to AER-901. Aerami initiated a Phase 1 trial of AER-901 in June 2021, and in August 2021, the FDA granted orphan drug designation to AER-901 for that indication.
AER-901 is delivered via Vectura’s Fox nebulizer. Aerami said that it expects to submit a 510(k) application for its own device, the Afina vibrating mesh soft mist inhaler, in 2022 and “plans to pursue internal development and partnering of AFINA-based pipeline opportunities for inhaled therapies targeted at addressing large markets with significant unmet needs.” Aerami’s pipeline currently includes AER-501 inhaled insulin, which has completed Phase 2 development, and AER-601, an inhaled short-acting GLP-1 analog in pre-clinical development.
Aerami CEO Steve Thornton commented, “We are deeply committed to advancing inhaled therapies that address severe respiratory and chronic diseases. This transaction is expected to provide significant capital and a platform to accelerate the development of our drug product candidates including taking our lead product, inhaled imatinib for the treatment of pulmonary arterial hypertension, into a planned Phase 2/3 trial in 2022.”
FoxWayne CEO Robb Knie said, “We see immense opportunities in Aerami’s approach to delivering inhaled therapies for targeted indications that present large unmet medical needs, including pulmonary arterial hypertension, a debilitating disease for which there currently are no available disease modifying therapies.”
Read the Aerami Therapeutics press release.
