BRIEF—Cyclerion views ways to fund zagociguat development

USA-based Cyclerion Therapeutics has announced corporate updates including advances in its zagociguat (formerly CY6463) mitochondrial disease program.

The company previously reported clinical data in adult patients with MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) that indicate that zagociguat may have potential as a first-ever therapy for patients with this rare, genetic mitochondrial disease.

In fourth-quarter 2022, Cyclerion met with the US Food and Drug Administration (FDA) and incorporated feedback from regulatory and mitochondrial disease clinical experts to refine the design of a Phase IIb study to evaluate zagociguat in patients with MELAS.

More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase IIb study.

Given the significant capital and capabilities necessary to ensure that the Phase IIb study is executed efficiently and with the highest quality, and the currently unfavorable capital market conditions, the company is actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat and its other clinical development candidates and to maximize shareholder value.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about its ability to continue as a going concern.”