ACE031 (95%) is a fusion protein consisting of activin receptor type IIB and IgG1-Fc, characterized by the amino acid sequence:
GRGEAETREC IYYNANWELE RTNQSGLERC IELVKKGCWL DDFNCYDRQE CVATEENPQV GGPEVTYEPP PTAPTGGGTH TCPPCPAPEL RTPEVTCVVV DVSHEDPEVK FNWYVDGVEV VLTVLHQDWL NGKEYKCKVS NKALPVPIEK REEMTKNQVS LTCLVKGFYP SDIAVEWESN FLYSKLTVDK SRWQQGNVFS CSVMHEALHN EGEQDKRLHC YASWRNSSGT YFCCCEGNFC NERFTHLPEA LGGPSVFLFP PKPKDTLMIS HNAKTKPREE QYNSTYRVVS TISKAKGQPR EPQVYTLPPS GQPENNYKTT PPVLDSDGSF HYTQKSLSLS PGK
This protein binds to myostatin and related ligands, promoting muscle growth by inhibiting negative regulators of muscle mass. ACE031 was generally well-tolerated, with observed adverse events mainly including injection site erythema. The pharmacokinetics showed a linear increase in mean ACE-031 AUC(0-∞) and C(max) with dose, and the half-life (T(½)) was approximately 10-15 days. Notably, the 3 mg/kg group exhibited statistically significant increases in total body lean mass and thigh muscle volume. Additionally, changes in serum biomarkers suggest potential benefits for bone and fat metabolism. Classified as a myostatin inhibitor, ACE031 holds promise for the treatment of conditions involving the loss of skeletal muscle mass, strength, and integrity.
