Company Product Description Indication Status
Phase I
Cytodyn Inc., of Vancouver, Wash. Leronlimab CCR5 antagonist Breast cancer Results in first 5 patients showed positive outcomes in metastatic triple-negative breast cancer and metastatic breast cancer
Evelo Biosciences Inc., of Cambridge, Mass.  EDP-1815 Anti-inflammatory agent Psoriasis Showed significant activity on multiple individual systemic markers of inflammation
Medivir AB, of Boston MIV-818 Prodrug designed to selectively treat liver cancer Liver cancer Pharmacokinetic analysis showed that patients were exposed only to low levels of MIV-818 and troxacitabine outside of the liver, providing experimental support for MIV-818's liver targeting
Phase II
Albireo Pharma Inc., of Boston Elobixibat Ileal sodium bile acid cotransporter inhibitor Nonalcoholic fatty liver disease; nonalcoholic steatohepatitis  Enrollment nearly complete; top-line data expected by mid-2020
Galera Therapeutics Inc., of Malvern, Pa. Avasopasem manganese (GC-4419) Superoxide dismutase stimulator Severe oral mucositis 2-year follow-up of phase IIb trial in those with head and neck cancer showed tumor outcomes were maintained in both dose groups vs. placebo; outcomes for 90-mg dose group used in ongoing phase III Roman trial were comparable to placebo across overall survival, progression-free survival, locoregional control and metastasis-free survival
Orthotrophix Inc., of Oakland, Calif. TPX-100 Matrix extracell phosphoglycoprotein modulator Osteoarthritis  In participants with mild to severe disease, knees treated with study drug showed statistically significant improvement vs. placebo in functions based on 17 measures in combined KOOS score and WOMAC scales; benefits seen by 6 months (p=0.02) and maintained through 12 months (p=0.04); pathological 3D shape changes in femur in treated knees also were reduced vs. placebo by 6 months (p=0.01) and maintained through 12 months (p=0.02)
VBI Vaccines Inc., of Cambridge, Mass. VBI-1901 GM-CSF receptor agonist Glioblastoma First of about 20 participants with first recurrent disease dosed in phase IIa study, in combination with AS-01B (Glaxosmithkline plc) adjuvant or GM-CSF; initial immunologic data from adjuvant arm expected in fourth quarter 2020
Phase III
Abbvie Inc., of North Chicago Venclexta (venetoclax)  BCL-2 protein inhibitor Acute myeloid leukemia Viale-C combination trial with low-dose cytarabine (LDAC) vs. LDAC plus placebo missed primary endpoint of statistically significant improvement in overall survival (OS), showing 25% reduction in risk of death vs. LDAC with placebo (p=0.11); median OS for venetoclax with LDAC arm was 7.2 months vs. 4.1 months for LDAC alone, extended to median OS of 8.4 months vs. 4.1 months, respectively, after 6 additional months of follow-up
Eyepoint Pharmaceuticals Inc., of Watertown, Mass. Yutiq (fluocinolone acetonide intravitreal implant) Glucocorticoid receptor agonist Uveitis Top-line 36-month follow-up data from second phase III in chronic non-infectious disease showed long-term ability to reduce flares, with recurrence rate of 46.5%
GW Pharmaceuticals plc, of Carlsbad, Calif. Epidiolex (cannabidiol) CBD oral solution Dravet syndrome Results from GWPCARE2 trial published in JAMA Neurology showed 2 doses, 10 and 20 mg/kg/day, significantly reduced convulsive seizure frequency vs. placebo in children, ages 2 to 18, with highly treatment-resistant disease; primary endpoint outcomes for the 10- and 20-mg/kg/day arms showed seizure reductions of 49% and 46% from baseline, respectively, vs 27% for placebo (10 mg/kg/day, p=0.0095 and 20 mg/kg/day, p=0.0299)
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Exportin 1 inhibitor Multiple myeloma Boston study assessing study drug dosed once-weekly in combination with once-weekly Velcade (bortezomib, Takeda Pharmaceutical Co. Ltd.) and low-dose dexamethasone vs. standard twice-weekly Velcade plus low-dose dex met primary endpoint of statistically significant increase in progression-free survival, with median of 13.93 months for Xpovio arm vs. 9.46 months for control, or reduction of 47% (p=0.0066)
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab)  PD-1 inhibitor Classical Hodgkin lymphoma Pivotal, confirmatory Keynote-204 trial in adults with relapsed/refractory disease met 1 primary endpoint of statistically significant improvement in progression-free survival vs.  brentuximab vedotin (Adcetris, Seattle Genetics Inc./Takeda Pharmaceutical Co. Ltd.) based on interim analysis conducted by an independent DMC; per prespecified analysis plan, other dual primary endpoint of overall survival was not formally tested at interim analysis so study is continuing
Urovant Sciences, a subsidiary of Sumitovant Biopharma Ltd., of London Vibegron Beta 3 adrenoceptor agonist Overactive bladder Results from Empowur trial, reported in March 2019, were published online in Journal of Urology
Phase IV
Vivus Inc., of Campbell, Calif. Qsymia (phentermine + topiramate)  Adrenergic receptor agonist Obesity Safety and efficacy study in adolescents, ages 12 to 17, was fully enrolled

Notes

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

No Comments