Company Product Description Indication Status
Phase I
Adastra Pharmaceuticals Inc., of Princeton, N.J. Zotiraciclib  Cyclin-dependent kinase 9 inhibitor Recurrent high-grade gliomas Zotiraciclib plus temozolomide exceeded or met the progression-free survival goal in phase Ib trial; in patients with isocitrate dehydrogenase mutations, the median PFS was longer than the historical control; data to be presented at an upcoming medical conference
Jounce Therapeutics Inc., of Cambridge, Mass. JTX-8064 LILRB2/ILT4 inhibitor Advanced solid tumors Started patient enrollment in the Innate study testing JTX-8064 as a monotherapy and in combination with a PD-1 inhibitor: either JTX-4014 or Keytruda (pembrolizumab, Merck & Co. Inc.)
Sorrento Therapeutics Inc., of San Diego Covi-Guard COVID-19 spike glycoprotein inhibitor COVID-19 Study in hospitalized patients with moderate COVID-19 withdrawn due to difficulty in recruiting
Phase II
Celltrion Inc., of Incheon, South Korea CT-P59 Monoclonal antibody targeting SARS-CoV-2 Mild to moderate COVID-19 Treatment with CT-P59 in phase II/III trial reduced progression rates to severe COVID-19 by 54% for mild to moderate patients and 68% for moderate patients 50 and older compared to placebo; patients treated with CT-P59 recovered in 5.4 days on average compared to 8.8 days for placebo (p= 0.0097)
Cytokinetics Inc., of South San Francisco CK-3773274 Myosin inhibitor Hypertrophic cardiomyopathy Treated first patient in cohort 2 of the REDWOOD-HCM study
Kintara Therapeutics Inc., of San Diego VAL-083 Bifunctional alkylating agent Glioblastoma  Started recruitment of 150-200 patients in the phase II/III GBM AGILE platform study
Phase III
Arcutis Biotherapeutics Inc., of Westlake Village, Calif.  Roflumilast cream (ARQ-151) Phosphodiesterase type 4 inhibitor  Atopic dermatitis  Started the Integument-1 and -2 studies, which will enroll 650 patients each; primary endpoint of both studies is Investigator Global Assessment (IGA) success, defined as a Validated IGA- Atopic Dermatitis score of clear or almost clear plus a 2-grade improvement from baseline at week 4
Gensight Biologics SA, of Paris Lumevoq (GS-010) MT-ND4 gene stimulator ND4 Leber hereditary optic neuropathy Data from the Rescue study published in Ophthalmology showed the average change against the worst recorded best-corrected visual acuity was -0.53 LogMAR (+26 ETDRS letters equivalent) in Lumevoq-treated eyes and -0.46 LogMAR (+23 ETDRS letters equivalent) in sham-treated eyes (p<0.0001)
Philogen SpA, of Siena, Italy Nidlegy Immunocytokines L19IL2 and L19TNF Locally advanced, fully resectable metastatic melanoma After review of data from 149 of the anticipated 214 patients, the data and safety monitoring board recommended continuing the study
Rockwell Medical Inc., of Wixom, Mich., and Shanghai Fosun Pharmaceutical Group Co. Ltd., of Shanghai Triferic dialysate Iron replacement Anemic patients with chronic kidney disease requiring hemodialysis Enrolled first patient in the RMFPC-13 study in China
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Sarilumab Inhibits IL-6-mediated signaling Giant cell arteritis Study suspended in April 2020 due to COVID-19 has been terminated due to protracted recruitment during pandemic
Synairgen plc, of Southampton, U.K. SNG-001 Interferon beta-1a Hospitalized COVID-19 Treated first of 610 patients who require supplemental oxygen in the SG018 study
Phase IV
Leo Pharma A/S, of Ballerup, Denmark Kyntheum  (brodalumab) Monoclonal antibody targeting interleukin-17 receptor A Moderate to severe plaque psoriasis First patient screened in the Cobra study comparing Kyntheum to Tremfya (guselkumab, Johnson & Johnson) in patients who had an inadequate response to Stelara (ustekinumab, J&J); primary study endpoint is the proportion of patients who achieve PASI 100 at week 16

Notes

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