296: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 2

Cyclarity argues its plaque-reversing cyclodextrin dimer could compress cardiovascular trial timelines and expand into a broader anti-aging pipeline.

• Phase 1b underway: Cyclarity completed its first-in-human trial (72 healthy volunteers, 5,000-page report) and has launched a phase 1b in coronary artery disease plaque patients, aiming for phase 2.
• FDA treats it hybrid: Regulators apply standard small-molecule/biologic safety and manufacturing review now, but the drug's isomeric (non-single-isomer) mixture draws biologic-like scrutiny; efficacy will ultimately require reduced heart attacks/strokes.

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