Ambros Therapeutics has officially launched as a clinical-stage biotechnology company focused on late-stage therapies for severe, underserved diseases, starting with neridronate for Complex Regional Pain Syndrome Type 1 (CRPS-1).

 

The company opens with an oversubscribed $125 million Series A financing, co-led by RA Capital Management and Patient Square Capital’s platform Enavate Sciences, and joined by Abiogen Pharma, Janus Henderson Investors, Arkin Bio, Balyasny Asset Management, Transhuman Capital, Adage Capital Partners LP, and other dedicated life sciences investors.

 

The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1 (CRPS-RISE), alongside regulatory preparations and pre-commercial activities. Ambros licensed exclusive North American rights to neridronate from Italian pharmaceutical company Abiogen Pharma S.p.A., with an option for broader market expansion.

 

Abiogen Pharma, recognized for its work in bisphosphonates, advanced neridronate through two Phase 3 studies and has treated over 600,000 patients for CRPS and other disorders. The US Food and Drug Administration has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for CRPS. The condition targeted by Ambros, CRPS-1, is a rare, debilitating disease with roughly 65,000 new U.S. cases each year.

 

“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,” said Jay Hagan, Chief Executive Officer of Ambros Therapeutics. “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.”

 

Massimo Di Martino, President of Abiogen Pharma, added: “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.”

 

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