Biotech

Abiogen Pharma participates in the birth of Ambros Therapeutics

The Pisa-based company is one of the co-founders of the American biotech, which was established with a $125 million financing

by Mo.D.

3' min read

Translated by AI
Versione italiana

3' min read

Translated by AI
Versione italiana

Italy's Abiogen Pharma aims for internationalisation in the US. The Italian pharmaceutical company active in the development of bisphosphonates participates as co-founder of Ambros Therapeutics, a US biotechnology company dedicated to the advanced clinical development of the drug for the treatment of Complex Regional Pain Syndrome Type 1 (CRPS-1), a rare and debilitating condition known as Algodystrophy.

Ambros Therapeutics is headquartered in Irvine, California, and is led by CEO Jay Hagan, who is joined by a team with experience in late-stage clinical development: Gail Cawkwell, chief medical officer; Michael Cruse, chief pperating officer; Kunal Kishnani, senior vice president corporate development; and Jennifer Lam, senior vice president finance and administration. The board of directors includes representatives from investors and Abiogen Pharma: chaired by industry veteran Keith Katkin it includes co-founder Vivek Ramaswamy, Matthew Hammond of RA Capital Management, Trit Garg of Patient Square Capital, Prisca Di Martino of Abiogen Pharma and CEO Hagan.

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Financial details

Ambros Therapeutics was established with $125 million (Series A funding) oversubscribed, co-led by RA Capital Management and Patient Square Capital's Enavate Sciences platform, with participation from specialised life sciences investors and Abiogen Pharma.

The project's first institutional funding (Series A round) is for advanced clinical development of the drug. The resources raised will support the pivotal Phase 3 clinical trial for CRPS-1 (CRPS-RISE), as well as the regulatory and pre-commercial activities required for access to the US market.

The participation of Abiogen Pharma

Abiogen Pharma, as part of a strategic partnership, has granted Ambros the exclusive rights to neridronate for North America, along with the option to expand into additional markets worldwide, and will maintain an active role in the development programme.

Neridronate, discovered and developed by Abiogen Pharma, is approved in Italy for the treatment of CRPS based on the results of two Phase 3 clinical trials. To date, it has been used in more than 600,000 patients, 'confirming a well-established safety profile and long-lasting clinical benefits, particularly on pain control,' the release states.

In light of this clinical evidence and real-world use experience, the Food and Drug Administration (FDA) has granted neridronate Breakthrough Therapy, Fast Track and Orphan Drug designations for the treatment of CRPS, accelerating the development pathway in the US for a rare, serious condition that still lacks approved therapies. CRPS-1, the subtype Ambros focuses on, is a rare disease with an estimated 65,000 new cases per year in the US.

"The birth of Ambros Therapeutics represents a fundamental strategic step in Abiogen Pharma's path of growth and internationalisation," said Massimo Di Martino, president of Abiogen Pharma, adding: "Neridronate is the result of a long scientific and clinical investment and a consolidated experience of use in Italy. With Ambros, we intend to enhance this asset in a highly competitive regulatory and market environment such as the US, with the aim of making an innovative therapy available to patients suffering from a rare disease with a high unmet clinical need'.

"Ambros is debuting a highly experienced management team and focusing on a therapy that has been used for over ten years in Italy for the treatment of CRPS," said Jay Hagan, continuing, "In the absence of approved drugs for CRPS-1 outside of Italy, we are excited to partner with Abiogen Pharma to accompany neridronate to Phase 3 registration development and make this therapy available to patients with an urgent clinical need.

Abiogen Pharma

 The Italian company based in Pisa was founded in 1997 and operates in several integrated areas: research and development, production of drugs under its own brand or for third parties, and marketing of its own and licensed drugs. Its target therapeutic areas include bone metabolism, pain treatment, as well as respiratory, metabolic (diabetes) and dermatological disorders. In 2022, Abiogen Pharma started its internationalisation process, which today covers Germany and Switzerland. With revenues of over EUR 168 million and 460 employees at the end of 2024, it ranks among the 15 largest Italian pharmaceutical companies.

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