Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC).
Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2.
“The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options,” said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. “We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices.”
The FDA’s Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4.
Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC.
