Ambros Therapeutics announced its launch as a clinical-stage biotechnology company advancing late-stage therapies for severe, underserved diseases beginning with neridronate for Complex Regional Pain Syndrome Type 1 (CRPS-1). The company launches with an oversubscribed USD 125 million Series A financing co-led by RA Capital Management and Patient Square Capital's platform Enavate Sciences, joined by Abiogen Pharma, Janus Henderson Investors, Arkin Bio, Balyasny Asset Management, Transhuman Capital, Adage Capital Partners LP and other life sciences investors.

The financing is expected to support the neridronate pivotal phase III clinical trial in CRPS-1 (CRPS-RISE) and related regulatory preparations and pre-commercial activities. Ambros licensed the rights to neridronate from the Italian pharmaceutical company, Abiogen Pharma S.p.A., under a strategic collaboration, providing Ambros with exclusive rights to neridronate in North America, with an option for broader market expansion.

Abiogen Pharma is a recognised leader in the discovery and development of bisphosphonates including the advancement of neridronate. Neridronate was approved in Italy based on the safety and efficacy demonstrated in two CRPS phase III studies and has been used for CRPS and other disorders in more than 600,000 patients to date.

The US Food and Drug Administration (FDA) has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug Designations (ODDs) for the treatment of CRPS. CRPS-1, the subtype Ambros is targeting, is a severe, debilitating rare disease with an estimated 65,000 new cases annually in the United States.

"We are launching Ambros with a seasoned leadership team and a therapy that has been used to treat CRPS in Italy for over ten years. With no approved medicines for CRPS-1 outside of Italy, we look forward to working with Abiogen Pharma to advance neridronate through Phase 3 and bring this therapy to patients who urgently need it," said Jay Hagan, Chief Executive Officer, Ambros Therapeutics.

In addition to Hagan, Ambros' leadership team includes Gail Cawkwell, MD, PhD, Chief Medical Officer; Michael Cruse, Chief Operating Officer; Kunal Kishnani, Senior Vice President, Corporate Development; and Jennifer Lam, Senior Vice President, Finance and Administration.

"We are excited to partner with Ambros to bring neridronate to patients outside of Italy, where there are currently no approved medicines. "With decades of leadership in bisphosphonate innovation at our dedicated research and development center, we believe in the potential for neridronate to address CRPS outside of Abiogen's core commercial markets," said Massimo Di Martino, President, Abiogen Pharma.

The Board of Directors is chaired by industry veteran Keith Katkin, and includes Co-Founder Vivek Ramaswamy; Matthew Hammond, PhD, RA Capital Management; Trit Garg, MD, Patient Square Capital; Prisca Di Martino, Abiogen Pharma; and Jay Hagan, Chief Executive Officer.

"Neridronate is one of the few late-stage programmes with a well-established mechanism, extensive real-world experience, and the potential to meaningfully change the trajectory of CRPS-1. We are pleased to support Ambros as it advances this important therapy through this pivotal programme to potentially be available for patients with very few options to address this painful disease," said Matthew Hammond, Partner, RA Capital Management.