Ambros Therapeutics has officially launched as a clinical-stage biotechnology firm, securing an oversubscribed $125 million Series A financing. The company is dedicated to developing treatments for severe, underserved diseases, with its initial focus on advancing neridronate for Complex Regional Pain Syndrome Type 1 (CRPS-1). This significant funding round was co-led by RA Capital Management and Patient Square Capital’s platform, Enavate Sciences, signaling strong investor confidence in the company's mission.
Addressing a Critical Unmet Need
Complex Regional Pain Syndrome Type 1 is a rare and severely debilitating condition that often follows a minor injury to a limb, affecting an estimated 65,000 new patients annually in the United States. Sufferers experience intense, continuous pain, swelling, and changes in the skin, yet there are currently no FDA-approved medicines available for this population. This significant treatment gap highlights the urgent need for an effective therapeutic intervention.
Ambros's lead candidate, neridronate, is a novel bisphosphonate with a well-established history in Italy, where it is approved for treating CRPS. The therapy has demonstrated lasting pain reduction and has been used in over 600,000 patients for various conditions, providing a substantial body of safety and efficacy data. This extensive real-world experience positions it as a promising treatment for patients who currently have very few options.
Strategic Financing and Clinical Pathway
The company's launch is supported by a robust $125 million Series A financing, which was oversubscribed due to strong investor confidence. The round was co-led by RA Capital Management and Enavate Sciences, with participation from a syndicate of dedicated life sciences investors including Abiogen Pharma. These funds are earmarked to advance neridronate through its next critical development phase and support pre-commercial activities.
Proceeds from the financing will directly support a pivotal Phase 3 clinical trial for neridronate, named CRPS-RISE, which is scheduled to begin in the first quarter of 2026. The program has already received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the U.S. Food and Drug Administration. These designations underscore the therapy's potential to address a serious condition and may help expedite its review process.
A Partnership Built on Expertise
Ambros has secured exclusive North American rights to neridronate through a strategic collaboration with the Italian pharmaceutical company Abiogen Pharma S.p.A. Abiogen Pharma discovered and developed the drug, establishing deep expertise in bisphosphonate innovation at its dedicated research centers. This partnership combines Abiogen's foundational knowledge with Ambros's late-stage development focus to bring the therapy to a new market.
The company is guided by a seasoned leadership team, with Jay Hagan appointed as Chief Executive Officer. He joins a group of experienced executives and a distinguished Board of Directors chaired by industry veteran Keith Katkin. This strong governance and operational expertise are crucial for navigating the path toward regulatory approval and potential commercialization for this important new therapy.
The launch of Ambros Therapeutics, backed by significant capital and an experienced team, marks a pivotal moment for patients suffering from CRPS-1. By advancing a therapy with a proven track record in Europe, the company offers a tangible prospect of a first-in-class treatment in the United States. This focused effort represents a significant step forward in addressing a long-standing and debilitating unmet medical need.