Aerami Therapeutics Goes Public Through SPAC Merger
Aerami Therapeutics, a biopharmaceutical company focused on developing inhaled therapies for severe respiratory diseases — including pulmonary arterial hypertension (PAH) — has entered into a merger agreement with FoxWayne Enterprises Acquisition, a special purpose acquisition company (SPAC).
The goal of this merger is to accelerate the development of Aerami’s therapeutic pipeline.
SPACs, also known as “blank check companies,” are essentially shell companies with no commercial operations that are set up by investors with the purpose of raising money through an initial public offering to fund the merger or acquisition of a private company. Once merged, the private company becomes public.
The deal, which is expected to close in the first months of 2022, will see the combined company be named Aerami Therapeutics Holdings, Inc., and be led by Steve Thornton, Aerami’s CEO, along with the rest of the company’s current management. The combined company’s common stock is expected to remain listed on the Nasdaq Capital Market.
“We are deeply committed to advancing inhaled therapies that address severe respiratory and chronic diseases,” Thornton said in a press release. “This transaction is expected to provide significant capital and a platform to accelerate the development of our [treatment] candidates including taking our lead product, inhaled imatinib for the treatment of pulmonary arterial hypertension, into a planned Phase 2/3 trial in 2022.”
Robb Knie, FoxWayne’s CEO, added: “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.”
Aerami’s lead candidate, named AER-901, is an inhaled formulation of imatinib that is expected to avoid the body-wide toxicity reported in a previous clinical trial testing an oral formulation of imatinib in people with PAH. This oral formulation, sold as Gleevec by Novartis, is currently approved for treating certain types of blood cancer.
Given that the therapy also was shown to reduce the tightening and stiffness of pulmonary arteries — a hallmark of PAH — Novartis launched the Phase 3 IMPRES trial (NCT00902174) to test it as an add-on PAH therapy.
While the oral therapy resulted in clinically meaningful improvements in blood flow and physical exercise capacity, almost half of the participants experienced serious adverse events thought to be related to the high dose used in the study.
Aerami expects that, by targeting the lungs only with its inhaled formulation, AER-901 will promote significant benefits to PAH patients, while limiting the rate and severity of adverse events.
The experimental therapy is designed to deliver consistent, well-tolerated, and effective levels of imatinib, once a day, via the Fox device licensed from the Vectura Group. The Fox device holds 510(k) clearance in the U.S. and a CE mark in Europe, both meaning that it was deemed safe for marketing.
In August, AER-901 received orphan drug designation in the U.S. for the treatment of PAH. This designation is meant to expedite the therapy’s clinical development by providing regulatory support and financial benefits, as well as a seven-year marketing exclusivity period upon regulatory approval.
The safety, tolerability, and pharmacokinetics (movement into, through, and out of the body) of single and multiple ascending doses of AER-901 are being evaluated in up to 78 healthy adults in a Phase 1 trial (NCT04903730). Participants, recruited at a single Australian site, are being assigned randomly to receive either one of five doses of AER-901 (5, 10, 20, 40, or 80 mg) or a placebo.
The trial, which began dosing in June, is expected to finish by the end of the year.
Should the therapy show a favorable safety and pharmacokinetics profile, Aerami plans to initiate a Phase 2/3 trial involving PAH patients early next year.
Meanwhile, the company also plans to pursue 510(k) clearance in the U.S. for its proprietary AFINA inhaler technology platform next year. It hopes the filing will allow it to muscle in on the rapidly growing global smart inhaler market.
According to Aerami, the company will look for internal development and partnering of AFINA-based pipeline opportunities for inhaled therapies designed to target large markets with significant unmet needs.