The name Vivek Ramaswamy probably rings a bell: biotech entrepreneur, presidential candidate, bureaucracy fighter in Washington.
Now he has a new venture in Irvine: seeking Food and Drug Administration approval for a novel treatment for a rare type of chronic pain.
Ramaswamy is co-founder of Ambros Therapeutics, which was launched with a $125 million Series A cash injection from investors including RA Capital Management of Boston.
The target: a rare and debilitating chronic pain condition known as CRPS-1 that follows an injury or trauma to the bone.
“We plan to start the study in the first quarter next year and anticipate top-line data from the pivotal study in early 2028,” Ambros CEO Jay Hagan told the Business Journal on Dec. 16, the day the new venture was announced.
Ramaswamy co-founded clinical-stage biotechnology company Ambros with industry veteran Keith Katkin, who serves as the company’s board chairman.
It is the second such Irvine company that Ramaswamy and Katkin have been involved with. Ramaswamy in 2014 founded Roivant Sciences Ltd., a firm that aimed to take advantage of abandoned or deprioritized drugs that aren’t priorities in the pipelines of large pharma companies. Ramaswamy invested in Urovant Sciences Ltd., a maker of urologic medications, and where Kotkin became CEO.
After Urovant went public and Ramaswamy sold his stake, Sumitomo Pharma bought it for an enterprise value of $681 million.
Katkin has a well-known track record in biopharmaceuticals. He was chief executive of Aliso Viejo-based Avanir Pharmaceuticals Inc., a nervous system disorder-focused drug development company that was sold for $3.5 billion sale to Japan-based Otsuka Pharmaceutical Co. in 2015.
Ambros, with offices at 18575 Jamboree Road, joins a long line of pharmaceutical firms that have found success in Orange County, including Aliso Viejo’s Glaukos Corp., which has a $6.5 billion market cap, and Irvine’s Tarsus Pharmaceuticals Inc., which has a $3.3 billion market cap.
Ramaswamy’s Roviant Sciences
A serial entrepreneur, Ramaswamy is best known to the U.S. public for running for president and co-leading the Department of Government Efficiency, better known as DOGE, alongside Elon Musk. Ramaswamy, who has held fundraisers in Orange County, is currently running for governor in Ohio.
The oversubscribed financing round for Ambros was co-led by RA Capital and Patient Square Capital’s Enavate Sciences of New York, according to the Dec. 16 announcement.
Italy’s Abiogen Pharma S.P.A.—from which Ambros licensed its lead candidate, neridronate—and other life sciences investors also took part in the fundraise.
CEO Hagan stresses that the new treatment is not a pain-relieving analgesic such as an opioid, a class of drugs that has gained notoriety due to their addictive powers.
Instead, neridronate is a bisphosphonate. This class of drugs is best known for its treatment of osteoporosis, which can make bones weak and brittle and hits women especially hard.
Neridronate is already in use in Italy.
CEO Hagan says Ambros doesn’t yet have a U.S. brand name for the product, “which usually comes much closer to potential approval.” If approved, the drug will be available by prescription only.
“Our market research indicates there were approximately 60,000 new diagnoses of CRPS in the U.S. last year alone,” Hagan says. “It’s important to remember that our approach is to treat the disease early in its presentation, and we plan to study it in patients who have been experiencing the disease for six months or less since the symptom onset.”
As for the Orange County headquarters, Hagan says: “We have a focused administrative leadership team in Irvine and will be building the company to support the planned clinical development of neridronate, regulatory filings, potential approval and ultimate commercialization of this new therapeutic option for patients with Complex Regional Pain Syndrome (CRPS).”
FDA Approval Being Sought
The funding for Ambros will go toward supporting a “pivotal phase 3 trial “of neridronate for CRPS-1 and “related regulatory preparations and pre-commercial activities,” Ambros said in the Dec. 16 release. There are currently no FDA-approved medicines to treat CRPS-1.
Phase 3 is one of several steps needed before a drug can be approved by the FDA and marketed in the U.S.
The FDA has supported the development of non-opioid pain management solutions and has granted neridronate Breakthrough Therapy, Fast Track and Orphan Drug designations for the treatment of CRPS.
Neridronate is a novel bisphosphonate that was discovered, developed and commercialized by Abiogen Pharma S.P.A. for the Italian market.
“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,” said Matthew Hammond, partner at financial backer RA Capital.
Seasoned Leadership
“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,” CEO Hagan said in the 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.
Orange County’s Healthy Healthcare Industry
Ambros Therapeutics joins a long list of biotech and medtech companies that have found success in Orange County. They include:
• Glaukos Corp., an Aliso Viejo-based ophthalmic company that makes the world’s smallest medical device to treat glaucoma and has a $6.5 billion market cap (NYSE: GKOS).
• Irvine-based Tarsus Pharmaceuticals, which has developed medications for eye infections, has a $3.3 billion market cap (Nasdaq: TARS).
• Seal Beach-based Dendreon Pharmaceuticals is developing cancer-fighting drugs.
• Irvine’s Beta Bionics Inc., which has developed an iLet Bionic Pancreas, went public earlier this year and now has a $1.3 billion market cap (Nasdaq: BBNX).
• Avid Bioservices in Tustin, a contract manufacturer of drugs, was acquired earlier this year for a $1.1 billion enterprise value.
• Irvine-based heart valve maker Edwards Lifesciences Corp. is Orange County’s most valuable publicly traded company with a $49.8 billion market cap (NYSE: EW).
• Applied Medical Resources Corp., a Rancho Santa Margarita maker of less-invasive surgical devices, is the second largest medtech employer in Orange County with 3,600 employees.
• San Clemente’s ICU Medical Inc., a maker of critical care medical products, has a $3.6 billion market cap (Nasdaq: ICUI).
• Axonics Inc. in Irvine, maker of implantable devices that help with overactive bladders, was acquired last year for $3.7 billion.
• Irvine-based Inari Medical Inc. makes devices that treat blood clots in veins, was acquired earlier this year for $4.7 billion.
• Aliso Viejo’s RxSight Inc., which has developed the world’s first and only eye lens that can be adjusted using light technology after cataract surgery, has a $518 million market cap (Nasdaq: RXST).
• Irvine’s CG Oncology Inc., which is developing a treatment for bladder cancer, has a $3 billion market cap (Nasdaq: CGON).
• Lake Forest’s Staar Surgical Co., a maker of intraocular lenses, is in a proxy battle over whether it’s worth $1.5 billion or more (Nasdaq: STAA).
• Irvine-based Masimo Corp., which makes noninvasive patient monitoring devices, has a $7.3 billion market cap (Nasdaq: MASI).
• Irvine-based Allergan, a unit of Abbvie, is the company behind the well-known wrinkle-removing toxin, Botox.
• Cathworks, a Newport Beach creator of a noninvasive method to diagnose heart disease, has been valued at close to $600 million.
