Ariceum Therapeutics' small cell lung cancer (SCLC) therapeutic satoreotide has been granted Orphan Drug Designation (ODD) by the FDA.
This designation will allow Ariceum to access development and commercialisation incentives from the regulatory board, including priority review, fee exemptions and eligibility for seven years of market exclusivity.
Preclinical data published in October 2024 has demonstrated the potential of 225Ac-saterotide in outperforming SSTR2-targeting agonists currently on the market, as well as initiating a complete durable response.
The therapeutic candidate will undergo Phase I/II clinical trials within the first quarter of this year under the trial name SANTANA-225.
225Ac-satoreotide is currently being developed as a theranotic pair alongside companion patient selection radiotracer 68GaSSO120 — allowing for the simultaneous diagnosis and treatment of cancers expressing SSTR2, such as SCLC and Merkel Cell Carcinoma (MCC).
SCLC is currently very difficult to treat, as two thirds of patients are diagnosed at an advanced stage of disease.
The late discovery of this disease results in a poor patient prognosis, with only 5–10% of patients surviving five years after diagnosis.
Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “Receiving ODD for 225Ac-satoreotide is a recognition of its potential as a treatment option for patients with SCLC and an important regulatory milestone for Ariceum."
"The FDA’s ODD will support our objective to accelerate the development of 225Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives.”