Vivek Ramaswamy has found time out of his campaign for governor of Ohio to launch a new biotech.
The new firm, Ambros Therapeutics, debuted Tuesday with a $125 million series A and plans to develop a non-opioid pain medicine approved in Italy.
The oversubscribed financing round was co-led by RA Capital Management and Enavate Sciences. Italy’s Abiogen Pharma—from which Ambros licensed its lead candidate, neridronate—and other life sciences investors also chipped in on the fundraise.
Ramaswamy co-founded Ambros with industry veteran Keith Katkin, who serves as the company’s board chair.
A serial entrepreneur known for his Roivant Sciences family of biotechs, Ramaswamy is perhaps better known to the broader U.S. public as a former co-lead of the Department of Government Efficiency alongside Elon Musk, a short stint that he held before launching his Ohio gubernatorial campaign in February.
The funding for Ambros, meanwhile, will go toward supporting a pivotal phase 3 trial of neridronate for Complex Regional Pain Syndrome type 1 (CRPS-1) “and related regulatory preparations and pre-commercial activities,” Ambros said in a Dec. 16 release.
Through a strategic collaboration, Irvine, California-based Ambros has gained North American rights to neridronate from Abiogen, with an option to broaden the covered market. The exact terms of the transaction were not disclosed. Abiogen’s commercial chief, Prisca Di Martino, sits on Ambros’ board.
CRPS-1, formerly known as reflex sympathetic dystrophy, is a rare disease characterized by intense and sometimes continuous pain in the affected limb following an injury to the bone. The condition is estimated to cause 65,000 new cases annually in the U.S., according to Ambros.
Neridronate, a bisphosphonate, has been marketed in Italy for CRPS since 2014. But German pain drug specialist Grünenthal had to discontinue two phase 3 trials of the drug in the indication in 2019 after a preplanned interim analysis suggested that the studies were unlikely to succeed. An open-label study in 2022 suggested that the drug’s pain-relieving effect may improve after longer follow-up time.
The FDA has supported the development of non-opioid pain management solutions. The agency in January approved Vertex’s Journavx, a pain reliever with the first new mechanism in more than two decades, and in September issued draft guidance to accelerate the development of non-opioid treatments for chronic pain.
“Neridronate is one of the few late-stage programs with a well-established mechanism, extensive real-world experience, and the potential to meaningfully change the trajectory of CRPS-1,” Matthew Hammond, partner at RA Capital Management, said in a statement.
For the new phase 3 trial, coded CRPS-RISE, Ambros plans to enroll 270 patients specifically with CRPS type 1—but not those with CRPS type 2. While both subsets of the condition are marked by intense pain, type 2 is directly linked to a nerve injury. About 90% of people with CRPS have type 1. The study carries an estimated primary completion date of December 2027, according to ClinicalTrials.gov.
“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,” Ambros CEO Jay Hagan said in a Dec. 16 release. “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.”
Hagan previously served as CEO of Regulus Therapeutics, which was bought by Novartis for $1.7 billion earlier this year. Gail Cawkwell, M.D., Ph.D., who was previously with Aclaris Therapeutics and Intercept Pharmaceuticals, is Ambros’ chief medical officer. Kunal Kishnani, who spent years at Ramaswamy’s “vant” family of biotechs, is the new firm’s senior vice president of corporate development.