Amani Therapeutics has raised $25 million in a Series A financing to advance its lead program, AM-01, a potential best-in-class therapy targeting serious neuropsychiatric disorders.
The newly formed biotechnology company, backed by RTW Investments, is focused on developing safer and more effective treatments for conditions such as schizophrenia. As part of the financing, Amani also secured worldwide rights from AstraZeneca to a Phase 3–ready novel chemical entity that will be incorporated into its lead therapy.
AM-01 is a fixed-dose combination product that includes clozapine, widely regarded as the most effective treatment for patients with treatment-resistant schizophrenia, alongside the newly licensed compound. The company aims to preserve clozapine’s efficacy while addressing its most significant safety limitation, severe neutropenia, as well as the burdensome blood monitoring requirements that have historically limited its use.
Clozapine remains the only medication proven to meaningfully improve symptoms in treatment-resistant schizophrenia and reduce suicide risk in patients with schizophrenia and schizoaffective disorder. However, its adoption has been constrained due to safety concerns, creating a significant unmet need in the market.
Alongside the financing, Amani Therapeutics announced key executive appointments. Rob Swoboda has joined as Chief Operating Officer, bringing experience from leadership roles at Karuna Therapeutics, bluebird bio, and Vertex Pharmaceuticals. Carla Canuso, MD, has been appointed Chief Medical Officer, with more than two decades of experience in neuropsychiatric clinical development at Johnson & Johnson.
The company will use the proceeds to advance AM-01 toward clinical development and position it as a safer alternative for patients who could benefit from clozapine’s therapeutic effects.
KEY QUOTE:
“Our understanding of the mechanism of clozapine-induced neutropenia, supported by results from our preclinical models, leads us to believe we have identified a solution to the decades-long challenge of developing a safer clozapine. By combining clozapine with the NCE licensed from AstraZeneca, we aim to mitigate the risk of neutropenia and the associated blood-monitoring requirements, while preserving clozapine’s efficacy.”
Carla Canuso, MD, Chief Medical Officer, Amani Therapeutics
