Company Product Description Indication Status
Phase I
Boehringer Ingelheim, of Ingelheim, Germany BI-767551 SARS-CoV-2 neutralizing antibody COVID-19 Started study testing the safety, pharmacokinetics and antiviral activity of the antibody dosed as either an infusion or an inhalation
Medincell SA, of Montpellier, France Ivermectin Binds glutamate-gated chloride channels COVID-19 prophylaxis No side effects observed in first 2 doses levels after continuous administration for over 1 month
Ology Bioservices Inc., of Alachua, Fla. ADM-03820 Cocktail of anti-SARS-CoV-2 monoclonal antibodies Healthy volunteers (eventually COVID-19) Started dosing of up to 40 volunteers in the study testing the cocktail dosed as either an intramuscular injection or intravenous infusion
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Casirivimab and imdevimab Anti-SARS-CoV-2 monoclonal antibodies Non-hospitalized COVID-19 Data from 275 patients in the phase I/II/III study published in the New England Journal of Medicine showed least-squares mean difference (combined antibody dose groups vs. placebo group) in the time-weighted average change in viral load from day 1 through day 7 was −0.56 log10 copies per milliliter for patients who were serum antibody negative at baseline and −0.41 log10 copies per milliliter in the overall trial population; 3% of patients who received the antibodies had at least one medically attended visit compared to 6% of patients who received placebo; 6% of patient who serum antibody negative at baseline that received the antibodies had at least one medically attended visit vs. 15% of patients who received placebo
Taiwan Liposome Co. (TLC), of Taipei, Taiwan  TLC-178 Liposomal formulation of vinca alkaloid chemotherapy vinorelbine Cancer Maximum tolerated dose in the phase I/II study was 31mg/m2; 50% of patients with soft tissue sarcoma treated with 24 mg/m2 to 31 mg/m2 dose had stable disease; disease control rate for all tumor types was 41%
Phase II
AB Science SA, of Paris Masitinib  Tyrosine kinase inhibitor targeting mast cells and macrophages Alzheimer’s disease In the phase IIb/III study AB09004, difference of least squares mean in Alzheimer's Disease Assessment Scale-Cognitive Subscale was -2.15 for masitinib compared to the placebo (p=0.0003); difference of least squares mean for Alzheimer’s Disease Cooperative Study Activities of Daily Living was 1.82 for masitinib compared to placebo (p= 0.0381)
Bavarian Nordic A/S, of Copenhagen BN-Brachyury Prime-boost vaccine Advanced chordoma In the 29-patient study testing BN-Brachyury plus radiation therapy, 2 patients achieved an objective response and 19 patients had stable disease; response criteria measuring tumor diameter may have missed responders due to spherical tumor shape; 4 of 6 patients analyzed for tumor volume had an objective response when tumor shrinkage was measured by volume
Brainstorm Cell Therapeutics Inc., of New York Nurown Autologous bone marrow-derived mesenchymal stem cells differentiated into cells that secrete high levels of neurotrophic factors Progressive multiple sclerosis Completed dosing in study; top-line data expected by the end of the 1Q21
Brii Biosciences Ltd., of Durham, N.C., and Beijing, China BRII-196 and BRII-198 SARS-CoV-2 neutralizing antibodies  Severe COVID-19 Study will examine the safety and efficacy of a BRII-196 and BRII-198 combination in addition to standard of care in hospitalized patients with severe COVID-19; dosing started in December 2020; initial results are expected in early 2021
Prilenia Therapeutics BV, of Naarden, the Netherlands Pridopidine S1R agonist Huntington's disease Data from the Pride-HD study published in The Journal of Huntington's Disease showed pridopidine produced a placebo-adjusted change in Total Functional Capacity (TFC) of 0.87 (p=0.0032); in early stage patients, placebo-adjusted change in TFC was 1.16 (p=0.0003); in the Open-Hart study, decline in TFC was -1.8 over five years, compared to an expected -5.0 for historical controls
Recardio Inc., of San Francisco Dutogliptin  DPP-IV inhibitor Myocardial infarction Interim data from first 24 patients treated in a 140-patient study published in the European Heart Journal showed dutogliptin plus G-CSF appeared to be safe
Phase III
Eusa Pharma Ltd., of Hemel Hempstead, U.K. Siltuximab  Monoclonal antibody targeting IL-6 COVID-19 with acute respiratory distress syndrome Enrolled first patient in the Silvar study testing the drug plus standard of care in patients in a hyperinflammatory state
Taiwan Liposome Co. (TLC), of Taipei, Taiwan  TLC-599 Bioseizer sustained-release formulation of dexamethasone sodium phosphate Knee osteoarthritis pain Excellence study is 98% enrolled; expects to complete enrollment before the end of 2020; top-line data expected in the second half of 2021
Vir Biotechnology Inc., of San Francisco, and Glaxosmithkline plc, of London VIR-7831 (GSK-4182136) Monoclonal antibody targeting SARS-CoV-2 Hospitalized COVID-19 Subtrial added to NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines study to test VIR-7831; initial enrollment will be 300 patients with mild to moderate COVID-19; if drug has a positive benefit:risk profile, trial will enroll an additional 700 patients, including those who are more severely ill; primary endpoint is sustained recovery for 14 days after release from the hospital

Notes

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