On 7 December, Aerami Therapeutics announced its plans to enter a business combination agreement with FoxWayne Enterprises Acquisition . Once the deal is completed, the combined companies will operate as Aerami Therapeutics Holdings. GlobalData believes that this merger will be a significant opportunity for Aerami to bolster its pulmonary arterial hypertension (PAH) drug portfolio, as the deal transaction proceeds will help advance the development of AER-901 (imatinib).

Despite the availability of multiple treatment options on the market—such as endothelin receptor antagonists (ERAs), PDE5 inhibitors, soluble guanylyl cyclase (sGC) stimulators and prostacyclin derivatives—PAH remains a largely incurable and fatal cardiopulmonary disease. At present, Aerami’s pipeline features a PAH drug candidate, namely imatinib, an inhaled, nebulised formulation of imatinib, currently in Phase I for PAH. Imatinib is a small molecule tyrosine kinase inhibitor (TKI) that blocks signalling by binding to the ATP-binding pocket necessary for receptor activation. Key opinion leaders (KOLs) interviewed by GlobalData have emphasised that they would like to see the development of TKIs because they act on the pathogenic mechanism of PAH. KOLs also said that there is a significant unmet need for a novel drug that works similarly to an anti-cancer drug and can suppress cell growth in the same way as a TKI.

Acquisitions and licensing agreements are a common trend in the PAH disease space. Under the agreement, Aerami Therapeutics Holdings aims to advance in the inhaled therapies space, focusing on respiratory and chronic diseases. The deal will involve FoxWayne issuing millions of shares of its common stock, equivalent to around $250m.

PAH patients often progress and die on triple therapy or have to go into transplant, so targeting a fourth pathway may offer an advantage for the drug. Through this merger, Aerami will have a significant opportunity to maximise the commercial potential of imatinib in the PAH space. Imatinib is expected to advance into a Phase II/III clinical trial for PAH next year.