IRVINE, Calif., March 31, 2026 (GLOBE NEWSWIRE) -- Ambros Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new U.S. patent application covering methods of selectively treating patients having Complex Regional Pain Syndrome Type 1 (CRPS-1), an orphan designated disease. The granting of this patent will enhance the Company’s intellectual property (IP) portfolio and strengthen the potential for neridronate exclusivity through 2045.
The allowed patent application, titled “Methods of Selectively Treating Complex Regional Pain Syndrome Type 1 (CRPS-1) Using Bisphosphonate Derivatives,” was filed in July 2025 and covers combining a positive triple-phase bone scan (TPBS) and specific attributes of the warm CRPS-subtype as a method for selecting likely responders to neridronate treatment. Ambros initiated enrollment in its pivotal CRPS-RISE (NCT07210515) Phase 3 clinical trial of neridronate in patients with CRPS-1 in the first quarter of 2026 using these same characteristics as part of eligibility determination in the trial.
“The granting of this patent will mark an important step for Ambros and our orphan drug neridronate, and represents the potential for meaningful value creation among patients, investors and all stakeholders,” said Jay Hagan, Chief Executive Officer of Ambros Therapeutics. “With an enhanced IP portfolio, we will be well-positioned to advance this important therapy through our pivotal program and potentially to patients with CRPS-1 who are in urgent need of new treatment options.”
“Supported by innovative analyses of data, the methods of patient selection covered by this allowed patent application represent a novel precision medicine approach to identifying patients with CRPS-1 who are likely to respond to neridronate,” said Gail Cawkwell, M.D., Ph.D., Chief Medical Officer of Ambros Therapeutics. “By leveraging a positive triple-phase bone scan with specific clinical manifestations of CRPS-1, we believe we can identify patients that are significantly more likely to benefit from neridronate, representing an important advancement in the management of this disease and a meaningful step forward for patients.”
About Neridronate
Neridronate is a novel bisphosphonate that was discovered, developed, and commercialized by Abiogen Pharma S.p.A. for the Italian market. Neridronate is approved and marketed in Italy for the treatment of Complex Regional Pain Syndrome (CRPS); clinical studies have demonstrated lasting pain reduction along with improvements in other CRPS related symptoms. Beyond CRPS, neridronate is approved in Italy for additional indications including osteogenesis imperfecta and Paget’s disease. Its well-established safety-profile and therapeutic benefits make it a potential promising treatment for patients with CRPS-1 worldwide. Recognizing its potential, the U.S. Food and Drug Administration (FDA) has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for the treatment of CRPS.
About Complex Regional Pain Syndrome Type 1 (CRPS-1)
Complex Regional Pain Syndrome Type 1 (CRPS-1; formerly known as RSD or Reflex Sympathetic Dystrophy) is a rare and debilitating condition typically following a limb injury or trauma to the bone. There are currently no FDA-approved medicines available to treat this high unmet need patient population. The condition is characterized by intense pain that can be continuous in the affected limb – typically in extremities such as the arm, leg, hand or foot. Patients with CRPS-1 often experience an evolving condition commencing with a "warm" phase lasting approximately six to twelve months where inflammation and other mechanisms cause the affected limb to become red, swollen, warm, and painful. In many patients this progresses to a chronic "cold" phase, where the affected limb changes its presentation and faces ongoing, debilitating pain.
About Ambros Therapeutics
Ambros Therapeutics, headquartered in Irvine, California, is a clinical-stage biotechnology company focused on the development of innovative and transformative medicines for diseases with high unmet medical need. Ambros’ lead investigational program targets intravenous neridronate as a medicine for warm CRPS-1. Ambros’ Phase 3 pivotal trial (CRPS-RISE) initiated enrollment in the first quarter of 2026 and represents a potential first-in-class approach to addressing a disease with no FDA-approved medicines.
Company Contact
Danielle Spangler
917-924-6752
investors@ambrostx.com
Argot Partners
ambros@argotpartners.com
212-600-1902
