Ariceum Therapeutics Secures FDA Orphan Drug Designation for 225Ac-Satoreotide
Ariceum Therapeutics, a Berlin-based private biotech company, has announced a significant regulatory milestone, with the US Food and Drug Administration (FDA) granting Orphan Drug Designation (ODD) to its proprietary radiopharmaceutical, 225Ac-satoreotide, for the treatment of Small Cell Lung Cancer (SCLC).
This designation underscores the drug’s potential to offer a new and much-needed treatment option for patients suffering from this aggressive and life-threatening disease.
SCLC is a particularly severe form of lung cancer, characterised by rapid progression and a poor prognosis. The five-year overall survival rate for patients with SCLC remains critically low at just 5-10%.
Therefore, the FDA’s decision to grant ODD to 225Ac-satoreotide reflects the urgent need for innovative therapies that can improve outcomes for those with limited treatment alternatives.
Advancing to Clinical Trials in 2025
Following this recognition, Ariceum has announced its plans to commence phase I/II human clinical trials in the first quarter of 2025 under the trial name SANTANA-225.
The company’s Chief Executive Officer described the ODD as a key milestone in Ariceum’s mission to accelerate the clinical development of 225Ac-satoreotide, bringing the treatment one step closer to patients who desperately need it.
The FDA grants Orphan Drug Designation to promising therapies targeting rare diseases, providing a range of developmental and commercial incentives to support drug development.
These benefits include seven years of market exclusivity in the US following regulatory approval and FDA guidance in clinical trial design, enhancing the likelihood of a successful development pathway.
Preclinical Data Highlights Promising Results
Prior to receiving ODD, Ariceum presented preclinical data in October 2024 that demonstrated the potential of 225Ac-satoreotide in tackling not only SCLC but also Merkel Cell Carcinoma (MCC) and other aggressive cancers.
The results were compelling, showing a high frequency of complete, durable responses and a 100% survival rate in preclinical models. These findings have reinforced the case for advancing the radiopharmaceutical into clinical trials with a focus on delivering a breakthrough in cancer treatment.
The Theranostic Approach: A Dual Solution
A critical component of Ariceum’s strategy is the development of a companion patient selection tracer, 68Ga-SSO120.
This tracer is being designed as part of a ‘theranostic pair’, enabling a combined approach to diagnosis and targeted radionuclide therapy.
By integrating diagnostics with treatment, Ariceum aims to improve precision in patient selection, ensuring that those most likely to benefit from 225Ac-satoreotide receive the therapy.
Aiming for a Life-Saving Solution
Ariceum Therapeutics has set its sights on providing a potentially life-saving therapy for patients facing limited treatment options.
The recognition of 225Ac-satoreotide by the FDA as an orphan drug marks an important step towards fulfilling that goal.
As the company prepares for clinical trials in early 2025, the biotech community and cancer specialists alike will be closely watching for further developments in what could be a significant breakthrough in the treatment of SCLC and beyond.
News Credits: FDA grants Orphan Drug Designation to Ariceum cancer therapy
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