Company Product Description Indication Status
Phase I
Aelix Therapeutics SL, of Barcelona DNA.HTI  T-cell therapeutic vaccine HIV infection Study met primary and secondary safety, tolerability and immunogenicity endpoints; for participants without HLA class I alleles (32/41), 8/20 vaccinated (40%) vs. 1 (8%) of 12 placebo recipients were able to remain off ART for 22 weeks (delta 32%, 80% CI [7.6; 55.7]), with pVL <2,000 copies/mL seen in 5 vaccine and 1 placebo recipient
Bioventus Inc., of Durham, N.C. MOTYS (PTP-001) Placental tissue particulate of amnion, chorion and umbilical cord tissue from full-term births Knee osteoarthritis First of 20 participants dosed in study 
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia Ifenprodil NMDA receptor antagonist COVID-19 infection Top-line results from completed phase IIb part of phase IIb/III trial in 150 people hospitalized with serious infection expected to report in last week of March 2021
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Verdiperstat Myeloperoxidase inhibitor Amyotrophic lateral sclerosis 50% enrollment met ahead of schedule in HEALEY ALS platform trial; verdiperstat arm to enroll 160 people, dosing 600 mg twice daily vs. placebo at 3-to-1 ratio for 24 weeks, with primary efficacy endpoint of change from baseline on ALS Functional Rating Scale-Revised 
Entera Bio Ltd., of Jerusalem EB-613 (teriparatide) Human parathyroid hormone Osteoporosis Trial met primary endpoint of increase in bone biomarker P1NP in 2.5-mg dose group, based on 3-month data (p<0.04); increase from baseline vs. placebo seen in serum bone biomarker osteocalcin (p<0.006) and decrease from baseline vs. placebo seen in serum bone biomarker CTX (p<0.015); 6-month data analysis expected in second quarter of 2021
Evgen Pharma plc, of Cheshire, U.K. SFX-01 (alpha-cyclodextrin-stabilized sulforaphane) Nrf2 stimulator COVID-19-related acute respiratory distress syndrome Data safety monitoring committee recommended phase II/III STAR COVID-19 trial continue based on review of safety data on first 60 participants; safety and preliminary efficacy data on first 100 enrollees expected in second quarter of 2021
Marinomed Biotech AG, of Korneuburg, Austria Tacrosolv (tacrolimus eye drops) T-lymphocyte inhibitor Allergic rhinoconjunctivitis First participants dosed in crossover trial that ensures each receives either high or low dose and placebo for 8 days each; efficacy endpoint is assessment of ocular symptoms every 15 minutes during grass pollen challenge using mean Total Ocular Symptom Score
Moderna Inc., of Cambridge, Mass. mRNA-1273.351 COVID-19 spike glycoprotein modulator for SARS-CoV-2 variant B.1.351 COVID-19 infection In amendment to ongoing study, first of 60 participants dosed with modified vaccine to address potential need for booster
Renibus Therapeutics Inc., of Dallas RBT-1 Heme oxygenase 1 modulator Acute kidney injury Trial initiated to assess effectiveness as preconditioner to prevent injury in people undergoing coronary artery bypass graft and/or cardiac valve surgery
Rigel Pharmaceuticals Inc., of South San Francisco Tavalisse (fostamatinib) SYK inhibitor COVID-19 infection Enrollment completed in NHLBI-sponsored trial in people hospitalized with infection
Transgene SA, of Strasbourg, France TG-4001 (tipapkinogen sovacivec) HPV E6/E7 protein modulator Anogenital cancer Ongoing trial amended to include combination with Bavencio (avelumab, Merck KGaA/Pfizer Inc.) vs. Bavencio monotherapy in recurrent/metastatic HPV16-positive anogenital cancer; enrollment expected to begin in second quarter of 2021, with progression-free survival as primary endpoint
Vicore Pharma Holding AB, of Gothenburg, Sweden C-21 Angiotensin II AT-2 receptor agonist Fibrotic disease In 12-person single-dose study, C-21 did not reach predefined area-under-curve endpoint but showed statistically significant evidence of restored skin temperature as measure of dilated peripheral resistance vessels
Phase III
Formosa Inc., of Cambridge, Mass., and Sosei Group Corp., of Tokyo APP-13007 Nanoparticle steroid formulation Inflammation and pain after cataract surgery Formosa dosed first patient in 370-patient, randomized study 
Genentech, unit of Roche Holding AG, of Basel, Switzerland, and Gilead Sciences Inc., of Foster City, Calif. Actemra (tocilizumab) + Veklury (remdesivir) IL-6 receptor antagonist + COVID-19 nonstructural protein 8 modulator/replicase polyprotein 1ab inhibitor COVID-19 infection In Remdacta trial, combination missed primary endpoint of improved time to hospital discharge for severe COVID-19 pneumonia and key secondary endpoints vs. Veklury alone
Kintor Pharmaceutical Ltd., of Suzhou, China Proxalutamide Androgen receptor antagonist COVID-19 infection Investigator-initiated trial in Brazil met primary endpoint at day 14 with reduction of 4.01 in WHO COVID-19 ordinal scale, from baseline of 5.663 to 1.653 for study drug, vs. reduction of 0.25 from baseline of 5.618 to 5.368 for standard of care (p<0.0001); trial showed 92% reduction in mortality risk (3.7% vs 47.6%, respectively) and shortened median hospital length stay by 9 days (median stay of 5 days vs. 14 days, respectively)
Novartis AG, of Basel, Switzerland Brolucizumab VEGF-A ligand inhibitor Diabetic macular edema Study testing drug vs. aflibercept in patients with visual impairment due to DME canceled due to COVID-19
Sun Pharmaceutical Industries Inc. USA (Sun Pharma), of Princeton, N.J. Ilumya (tildrakizumab-asmn) IL-23 antagonist Psoriasis 5-year results based on a pooled analysis of Resurface 1 and 2 extension studies, published in British Journal of Dermatology, showed study drug maintained consistent, high level of skin clearance with no new safety signals in people with moderate to severe disease
Vir Biotechnology Inc., of San Francisco, and Glaxosmithkline plc, of London VIR-7831 COVID-19 spike glycoprotein modulator COVID-19 infection Independent data monitoring committee recommended early halt of Comet-Ice monotherapy trial for early treatment of infection in adults at high risk of hospitalization after interim analysis of data from 583 participants showed 85% (p=0.002) reduction in hospitalization or death  vs. placebo

Notes

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