Company Product Description Indication Status
Phase II
I-Mab Biopharma Co. Ltd., of Shanghai TJ-202 (MOR-202) CD38 antibody Relapsed or refractory multiple myeloma Dosed first patient in mainland China in registrational study
Orphazyme A/S, of Copenhagen Arimoclomol Activates heat-shock response Niemann-Pick disease type C 12-month interim data from open-label extension of phase II/III study show continued positive impact on disease progression over 2 years; separate data from post-hoc genetic subgroup analysis also show efficacy; regulatory submissions in U.S. and Europe expected in the first half of 2020 and second half of 2020, respectively
Phase III
Incyte Corp., of Wilmington, Del. Itacitinib Selective JAK1 inhibitor Acute graft-vs.-host disease Pivotal Gravitas-301 study in combination with corticosteroids in treatment-naïve patients did not meet primary endpoint of improving overall response rate at day 28 vs. placebo plus corticosteroids (74% vs. 66.4%, p=0.08); no difference observed in non-relapse mortality at month 6, the key secondary endpoint, between treatment and placebo arms
Novan Inc., of Morrisville, N.C. SB-206 Nitric oxide-releasing topical gel Molluscum contagiosum Top-line data showed B-Simple program did not achieve primary endpoint in B-Simple1 or B-Simple2, defined as proportion of patients with complete clearance of all treatable lesions at week 12 (p=0.375 and p=062, respectively); multiple sensitivity analyses, however, were supportive and consistent across both studies; the trials remain ongoing, awaiting 24-week safety data


For more information about individual companies and/or products, see Cortellis.

No Comments