Lefamulin is a novel antibiotic of the pleuromutilin class. Sinovant is initially developing lefamulin for community-acquired bacterial pneumonia (CABP), one of the leading causes of mortality in Mainland China. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP.
Lefamulin has successfully completed two global Phase 3 studies in patients with moderate and severe CABP. New Drug Applications (NDAs) for both the oral and intravenous formulations of lefamulin were submitted to the US FDA in Q4 2018.
Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. Sinovant is initially developing derazantinib for the treatment of intrahepatic cholangiocarcinoma (iCCA), a devastating form of biliary tract cancer with comparatively high incidence in Greater China and parts of Asia and no approved therapies. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy.
Derazantinib is currently being evaluated in a registration-enabling study in patients with FGFR2 fusion-positive second-line iCCA in the United States and Europe.
ANG-3777 is a potent, small molecule mimetic of HGF which activates the c-Met receptor. Activation of the HGF/c-Met pathway stimulates blood vessel formation, tissue repair and regeneration, and reduces deposition of extracellular matrix, a non-cellular collection of macromolecules produced in excess by injured tissue that leads to organ dysfunction and fibrosis. In a prior Phase 2 study with ANG-3777 in patients with poor kidney function post-transplant, treated patients were shown to have improved renal function, decreased serum creatinine, and reduced need for dialysis relative to patients who received placebo.
ANG-3777 is currently being evaluated in a Phase 3 study in patients presenting with early signs of DGF and a Phase 2 study in patients at increased risk for AKI following cardiovascular surgery.