SOUTH SAN FRANCISCO, Calif.– Circle Pharma announced today that its investigational therapy CID-078 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC), a highly aggressive and difficult-to-treat form of lung cancer.
The designation highlights the potential of CID-078 to address a critical unmet medical need. SCLC accounts for roughly 13–15% of all lung cancer diagnoses and is strongly linked to tobacco use. The disease is marked by rapid progression, high recurrence rates, and poor overall survival, even with recent advancements in therapy.
“The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options,” said Dr. Michael C. Cox, Senior Vice President and Head of Early Development at Circle Pharma. “We are committed to advancing CID-078 to offer new hope for patients who currently face limited therapeutic choices.”
The FDA’s Orphan Drug Designation is granted to therapies intended for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The status provides several incentives for drug developers, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, and eligibility for research funding from the FDA.
CID-078 is currently being evaluated in a Phase 1 clinical trial (NCT06577987) to assess its safety, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced solid tumors, including SCLC.
The drug is part of Circle Pharma’s Cyclin A/B RxL Inhibitor program and represents a novel class of macrocycle therapeutics. CID-078 is designed to selectively disrupt the interactions between cyclins A and B and key regulators of cell cycle progression, such as E2F and Myt1. Preclinical models have shown the agent’s ability to induce tumor regression as a single agent, suggesting strong therapeutic potential in cancers driven by cell cycle dysregulation.
The company’s latest milestone underscores its focus on targeting previously “undruggable” cancer pathways using innovative macrocyclic compounds, with a goal of delivering transformative therapies to patients with limited options. (Source: IANS)
