High Point Clinical Trial Center (HPCTC) and Amyndas Pharmaceuticals jointly announce the completion of the AMY-101 First in Human (FIH) study, which assessed safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after a Single Ascending Dose (SAD) and Multiple Doses (MD) of AMY-101 administered systemically (via subcutaneous or intravenous routes) in healthy male volunteers.
AMY-101 is a C3-targeted complement inhibitor that has the potential to target a wide range of complement mediated conditions which are largely driven by aberrant C3 activation, such as PNH and C3G, as well as conditions where modulation of C3 could be beneficial, for example ABO-incompatible kidney transplantation, AMD, COPD and periodontal disease amongst others.
“AMY-101 is a third generation compstatin with significant improvements over previous generation molecules of the family of compstatins. The completion of the FIH study is major milestone in the clinical development of AMY-101 and the good safety profile observed demonstrates once again that inhibiting complement at the C3 level can be safely achieved in the clinic,” said Prof. John D. Lambris, founder of Amyndas and inventor of novel compstatin drugs, including AMY-101.
To read the entire press release: www.amyndas.com