#USA #Irvine #Neridronate #Ambros Therapeutics #CRPS-1

Ambros Therapeutics Secures $125 Million Funding

Ambros Therapeutics has officially launched as a clinical-stage biotechnology company with a mission to develop advanced treatments for severe diseases that are currently underserved. The company has announced its successful round of Series A financing, securing $125 million. This significant funding will primarily go towards pushing Neridronate through its Phase 3 clinical trials for Complex Regional Pain Syndrome Type 1 (CRPS-1).

Neridronate, a novel bisphosphonate drug initially developed by Abiogen Pharma, has exhibited efficacy and safety in treating CRPS-1 within the Italian market. It has been used in over 600,000 patients in Italy to date, showcasing its potential to alleviate severe pain and related symptoms associated with this debilitating condition. The drug has received multiple designations from the U.S. Food and Drug Administration (FDA), including Breakthrough Therapy, Fast Track, and Orphan Drug status for CRPS-1, emphasizing its significance and urgency for those in need of effective treatment.

Strong Leadership Team

The leadership team at Ambros is headed by Jay Hagan, who has been appointed as the Chief Executive Officer. He leads a team experienced in late-stage drug development and will work closely with co-founder and Chairman Keith Katkin. Alongside them, notable members include Gail Cawkwell, M.D., Ph.D., as Chief Medical Officer, and Michael Cruse as Chief Operating Officer, ensuring a robust framework for the ambitious goals of the company.

The company’s new funding is overseen by a consortium of reputable investors including RA Capital Management and Patient Square Capital's Enavate Sciences, alongside several dedicated life sciences investors. This over-subscribed Series A round underscores the confidence within the investment community in Ambros’ potential to significantly impact the treatment landscape for CRPS-1.

Emphasis on Addressing Unmet Needs

Currently, CRPS-1 is a rare but debilitating condition that can arise from injuries or trauma, leading to severe, chronic pain, mainly affecting extremities such as arms or legs. It is characterized by phases of varying pain and inflammation, and the market for its treatment is marked by a glaring absence of FDA-approved therapies, particularly in the U.S. This makes the development of Neridronate crucial, as it aims to fill this high unmet medical need.

In the U.S. alone, there are approximately 65,000 new cases of CRPS-1 reported annually, highlighting the critical demand for innovative treatment options. The FDA's support in granting various designations to Neridronate further emphasizes its potential impact on improving patient lives.

Collaboration with Abiogen Pharma

Ambros has entered into a strategic collaboration with Abiogen Pharma, granting exclusive rights to the North American market for Neridronate, with potential for further geographical expansion. This partnership is not only rooted in shared goals of patient care but also taps into Abiogen's decades of experience in developing and marketing bisphosphonates.

Ambros Therapeutics aims to initiate enrollment for the pivotal Phase 3 trial (referred to as CRPS-RISE) in early 2026, setting the stage for a potential breakthrough in treating CRPS-1.

Looking Forward

With a focused vision and a solid financial foundation, Ambros Therapeutics aspires to deliver essential therapies that could transform lives for patients suffering from CRPS-1. Under the leadership of a seasoned team and backed by a committed investor base, the path toward making Neridronate available in regions outside Italy appears promising. The fiscal success of this biotechnology firm reflects a growing confidence in advancements against complex health challenges that continue to plague patient communities.

As Ambros continues to grow, the biopharmaceutical landscape will be closely watching its success in bringing a highly necessary treatment from the drawing board into the hands of those most in need.