$125M Series A: Ambros Therapeutics to Begin Phase 3 Trials for Non-Opioid Pain Therapy

Irvine-based Ambros Therapeutics Inc. has launched as a clinical-stage biotechnology company with a $125 million Series A round to advance late-stage therapies for severe, underserved diseases, beginning with neridronate for Complex Regional Pain Syndrome Type 1 (CRPS-1).

The round was 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 and Adage Capital Partners LP. The financing is expected to support a pivotal Phase 3 clinical trial of neridronate in CRPS-1, known as CRPS-RISE, and related regulatory preparations and pre-commercial activities.

“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, in a statement. “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.”

CRPS-1 is a rare and debilitating condition following an injury or trauma to the bone. The condition is characterized by severe pain that can be continuous in the affected limb. There are currently no U.S. Food and Drug Administration-approved medicines available to treat CRPS-1.

Neridronate has demonstrated lasting pain reduction along with improvements in other related symptoms. It was discovered, developed and commercialized by Abiogen Pharma S.p.A. for the Italian market. Ambros has licensed the rights to neridronate from the Italian pharmaceutical company, giving it exclusive rights in North America, with an option for broader market expansion.

The FDA has granted neridronate Breakthrough Therapy, Fast Track and Orphan Drug designations for the treatment of CRPS. CRPS-1 is estimated to affect about 65,000 new patients annually in the U.S., and Ambros plans to initiate enrollment for its Phase 3 registrational trial in the first quarter of 2026.

Information for this article was sourced from Ambros Therapeutics.