Company Product Description Indication Status
Phase I
Gilead Sciences Inc., of Foster City, Calif. GS-6207 Disrupts HIV capsid HIV-1 Phase Ib results testing subcutaneous formulation showed antiviral activity through last day of monotherapy, day 10, with significantly greater reductions in HIV-1 RNA vs. placebo across all treatment groups (20 to 750 mg; all p<0.0001)
Provention Bio Inc., of Oldwick, N.J. PRV-3279 Humanized diabody targeting B-cell surface proteins CD32B and CD79B Systemic lupus erythematosus Top-line data from phase Ib portion in healthy volunteers showed drug was well-tolerated, with no serious adverse events, and pharmacokinetic parameters were generally dose-proportional; high levels of B-cell engagement resulted in durable pharmacodynamic responses; anti-drug antibody production was observed at both dose levels tested, but immunogenicity was found not to affect exposure, safety or pharmacodynamic parameters
Phase II
Engage Therapeutics Inc., of Summit, N.J. Staccato alprazolam Inhaled formulation of benzodiazepine  Active epileptic seizure Phase IIb States study met primary endpoint, with proportion of responders (50 of 76) achieving cessation of seizure activity within 2 minutes of treatment administration and no recurrence within 2 hours; phase III study expected to start in 2020
QED Therapeutics Inc., of San Francisco, a subsidiary of Bridgebio LLC Infigratinib (BGJ-398) Oral FGFR1-3 selective tyrosine kinase inhibitor Solid tumors  Patients dosed in trial testing drug in those whose disease is positive for FGFR1-3 gene fusions/translocations or other FGFR alterations; open-label study to assess overall response rate as primary endpoint
Tenax Therapeutics Inc., of Morrisville, N.C. Levosimendan Calcium sensitizer Pulmonary hypertension and heart failure with preserved ejection fraction Completed enrollment in Help trial; primary endpoint is change from baseline  in pulmonary capillary wedge pressure with bicycle exercise (25 watts) at week 6 following 5 weekly infusions; top-line data expected in second quarter of 2020
Phase III
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Cediranib  VEGF receptor tyrosine kinase inhibitor Platinum-sensitive relapsed ovarian cancer Results showed GY004 study testing combination with Lynparza (olaparib) vs. platinum-based chemotherapy did not meet primary endpoint in intent-to-treat population of statistically significant improvement in progression-free survival
QED Therapeutics Inc., of San Francisco, a subsidiary of Bridgebio LLC Infigratinib (BGJ-398) Oral FGFR1-3 selective tyrosine kinase inhibitor Invasive urothelial carcinoma Patients dosed in Proof 302 trial testing drug as adjuvant treatment in patients whose cancers harbor susceptible FGFR3 genetic alterations and who are at high risk of recurrence following surgical resection; primary outcome is disease-free survival


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

No Comments