U.S. FDA Awards Orphan Drug Status to Ariceum Therapeutics' Exclusive Radiopharmaceutical Cancer Treatment
Friday, February 07, 2025
Ariceum Therapeutics, a private biotech company focused on developing radiopharmaceutical treatments for diagnosing and treating certain difficult-to-treat cancers, has received Orphan Drug Status from the U.S. Food and Drug Administration (FDA) for 225Ac-SSO110 (satoreotide) in the treatment of Small Cell Lung Cancer (SCLC).
SCLC is an aggressive cancer with limited treatment options, creating a significant unmet medical need. Around two-thirds of patients are diagnosed at an advanced stage when the disease has already spread extensively. This leads to a poor prognosis, with overall survival rates of just 5-10% over five years. Ariceum plans to begin Phase I/II clinical trials of 225Ac-satoreotide under the name SANTANA-225 in the first quarter of 2025.
The FDA grants Orphan Drug Status to drugs and biologics with potential to diagnose or treat rare diseases affecting fewer than 200,000 people in the U.S. This designation provides benefits such as seven years of market exclusivity following approval, assistance with clinical trial design, and exemption from FDA user fees.
In October 2024, Ariceum published preclinical data highlighting the potential of 225Ac-satoreotide to surpass SSTR2-targeting agonists. The treatment showed a high rate of complete and lasting responses, along with 100% survival, supporting further clinical research for SCLC, Merkel Cell Carcinoma (MCC), and other aggressive cancers. 225Ac-satoreotide, combined with the companion diagnostic tracer 68Ga-SSO120, is being developed as a ‘theranostic pair’ for both diagnosis and targeted radionuclide treatment of cancers expressing SSTR2, including SCLC and MCC.
Source: ariceum-therapeutics.com
