Global Trends

New Biotech Startup Secures $125 Million to Advance Pain Medication

Ambros Therapeutics, co-founded by Vivek Ramaswamy, is focused on bringing Neridronate, a non-opioid pain drug approved in Italy, to the North American market.

Ambros Therapeutics, a newly launched biotechnology company, debuted with an oversubscribed Series A financing round of $125 million. The firm was co-founded by prominent entrepreneur Vivek Ramaswamy (known for his involvement in the Roivant Sciences ecosystem) and industry veteran Keith Katkin.

Funding and Lead Candidate Details

  • Investment Capital: $125 million in Series A funding, co-led by RA Capital Management and Enavate Sciences, with participation from Italy’s Abiogen Pharma and other life sciences investors.

  • Lead Candidate: Neridronate, a bisphosphonate drug, was licensed by Ambros from Abiogen Pharma (Italy) for North American development and commercialization rights.

  • Use of Funds: The capital will support a pivotal Phase 3 trial (CRPS-RISE) for Neridronate targeting Complex Regional Pain Syndrome type 1 (CRPS-1), along with associated regulatory preparations and initial pre-commercial activities.

About Neridronate and CRPS-1

CRPS-1 (formerly known as reflex sympathetic dystrophy) is a rare condition characterized by intense, sometimes continuous pain in the affected limb following a bone injury. It is estimated to result in about 65,000 new cases annually in the U.S. Type 1 accounts for approximately 90% of CRPS cases and is not directly linked to a confirmed nerve injury, unlike Type 2.

Neridronate has been available in Italy for CRPS since 2014. However, a German pain drug specialist was forced to discontinue two Phase 3 trials for the drug in 2019 after a preplanned interim analysis suggested a low likelihood of success. Nevertheless, an open-label study in 2022 suggested that the drug’s pain-relieving effect might improve with longer follow-up time.

With no approved medicines for CRPS-1 outside of Italy, Ambros, led by CEO Jay Hagan, aims to rapidly advance this therapy to U.S. patients. The new Phase 3 trial is expected to enroll 270 patients specifically with CRPS type 1 and has an estimated primary completion date of December 2027.

The development of non-opioid pain management solutions is a key priority supported by the U.S. Food and Drug Administration (FDA).

Source: https://www.fiercebiotech.com/biotech/ramaswamy-backed-ambros-therapeutics-launches-125m-develop-pain-drug

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