Company Product Description Indication Status
Phase I
Codiak Biosciences Inc., of Cambridge, Mass. ExoIL-12 Exosome displaying IL-12 Healthy volunteers (eventually cutaneous T-cell lymphoma) No observations of treatment-related adverse events, including chills, fever, fatigue, dizziness, myalgia, headache or back pain; levels of IL-12 below the limit of quantification; plans to enroll patients in first quarter of 2021
Emergent Biosolutions, of Gaithersburg, Md. COVID-HIG COVID-19 human hyperimmune globulin Post-SARS-CoV-2 exposure prophylaxis Starting study testing safety and pharmacokinetics of 3 dose levels administered as a single or repeat IV dose
Phase II
Altimmune Inc., of Gaithersburg, Md.  HepTcell Nine synthetic HBV-derived peptides plus a TLR9-based adjuvant Chronic hepatitis B virus infection Enrolled first of 80 patients in the study testing treatment with the drug every 4 weeks for 24 weeks; primary efficacy endpoint is virological response, defined as a 1-log reduction in HBsAg levels from baseline at 24 weeks; secondary endpoints include reactivation of anti-HBV T-cell responses, HBsAg clearance and other assessments of virologic response
Hepion Pharmaceuticals Inc., of Edison, N.J. CRV-431 Cyclophilin inhibitor Nonalcoholic steatohepatitis In the Ambition study, the 12 patients taking the low dose had reductions in alanine aminotransferase and aspartate aminotransferase from baseline to day 28 of 18.4% and 12.1%, respectively, compared to a 0.65% reduction and a 2.52% increase, respectively, for those taking placebo; treatment with high dose is ongoing
Lipocine Inc., of Salt Lake City LPCN-1144  Oral prodrug of testosterone Noncirrhotic nonalcoholic steatohepatitis Started enrolling patients in the open-label extension of the ongoing Lift study to collect data for up to a total of 72 weeks of therapy
Neurorx Inc., of Radnor, Pa. and Relief Therapeutics Holding AG, of Geneva, Switzerland Zyesami (aviptadil) Formulation of vasoactive intestinal polypeptide Respiratory failure in patients with critical COVID-19 Completed enrollment of 165 patients; top-line data expected in late January to early February 2021
Phase III
Nicox SA, of Sophia Antipolis, France, and Ocumension Therapeutics Ltd., of Shanghai Zerviate (cetirizine) Ocular formulation of the histamine-1 receptor antagonist Allergic conjunctivitis Enrolled first of approximately 296 patients in China-based study
Protalix Biotherapeutics Inc., of Carmiel, Israel, and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici SpA, of Parma, Italy Pegunigalsidase alfa (PRX–102)  Chemically modified stabilized version of alpha-galactosidase-A  Fabry disease  Final results from the Bridge study showed mean annualized estimated glomerular filtration rate in male patients improved from -6.36 mL/min/1.73m2/year to -1.73 mL/min/1.73m2/year and in female patients improved from -5.03 mL/min/1.73m2/year to -0.21 mL/min/1.73m2/year after being switched from agalsidase alfa to PRX-102
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Casirivimab and imdevimab Monoclonal antibodies targeting SARS-CoV-2 Hospitalized COVID-19 Treatment of seronegative patients with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR=0.78); antibody cocktail reduced the time-weighted average daily viral load through day 7 by -0.54 log10 copies/mL, and through day 11 by -0.63 log10 copies/mL (nominal p=0.002 for combined doses)
Sinopharm Group Co. Ltd., of Beijing COVID-19 vaccine Inactivated coronavirus COVID-19 prophylaxis Neutralizing antibody positive conversion rate was 99.52%; vaccine provided 79.34% efficacy against developing COVID-19

Notes

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