Afuco™ Anti-Human MMP9 ADCC Recombinant Antibody (GS-5745), ADCC Enhanced

The proportion of patients achieving [A] EBS clinical remission, [B] MCS response, [C] endoscopic response, and [D] mucosal healing at Week 8. [E] Change from baseline in partial MCS over time. [A–D] Values indicate percentage of patients per treatment group achieving response. Error bars indicate upper and lower 95% confidence interval. [E] Data represented as mean with error bars indicating SD. EBS clinical remission defined as endoscopic subscore of 0 or 1, rectal bleeding score of 0, and ≥1-point decrease in stool frequency to achieve a subscore of 0 or 1; MCS response defined as reduction of ≥3 points and at least 30% from baseline with decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1; endoscopic response defined as endoscopic subscore of 0 or 1; mucosal healing defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. Partial MCS comprised subscores from rectal bleeding, stool frequency, and PGA. aPatients with mucosal healing at baseline were excluded from the analysis. EBS, endoscopy/bleeding/stool; MCS, Mayo clinical score; PGA, physician's global assessment; Q2W, every 2 weeks; QW, weekly; SD, standard deviation.

Sandborn, W. J., Bhandari, B. R., Randall, C., Younes, Z. H., Romanczyk, T., Xin, Y., ... & Sundy, J. S. (2018). Andecaliximab [Anti-matrix Metalloproteinase-9] Induction Therapy for Ulcerative Colitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study in Patients With Moderate to Severe Disease. Journal of Crohn's and Colitis,12(9), 1021-1029.

Error bars indicate SD. Arrows indicate drug administration for Q2W dosing. All PK samples were collected before dosing on respective treatment days. For the 150 mg Q2W group, the Week 8 concentration was determined 2 weeks following the previous dose, whereas Week 1 and Week 5 concentrations were determined 1 week following the previous dose. PK, pharmacokinetic; Q2W, every 2 weeks; QW, weekly; SD, standard deviation.

Sandborn, W. J., Bhandari, B. R., Randall, C., Younes, Z. H., Romanczyk, T., Xin, Y., ... & Sundy, J. S. (2018). Andecaliximab [Anti-matrix Metalloproteinase-9] Induction Therapy for Ulcerative Colitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study in Patients With Moderate to Severe Disease. Journal of Crohn's and Colitis,12(9), 1021-1029.

Marshall, D. C., Lyman, S. K., McCauley, S., Kovalenko, M., Spangler, R., Liu, C., ... & Mikels-Vigdal, A. (2015). Selective allosteric inhibition of MMP9 is efficacious in preclinical models of ulcerative colitis and colorectal cancer. PloS one,10(5), e0127063.