Company Product Description Indication Status
Phase I
Actinium Pharmaceuticals Inc., of New York Iomab ACT CD45 targeting antibody radiation conjugate  Relapsed and refractory B-cell acute lymphoblastic leukemia  Patient enrollment begun
Akari Therapeutics plc, of New York rVA-576 (nomacopan) Inhibits C5 complement and leukotriene B4 Atopic keratoconjunctivitis Phase I/II trial terminated early due to disruptions caused by ongoing COVID-19 pandemic; decision not related to safety or efficacy concerns
Assembly Biosciences Inc., of San Francisco ABI-M201 Microbiome-targeted live biotherapeutic Mild to moderately active ulcerative colitis Sponsor decided to terminate trial
Hutchmed China Meditech Ltd., of Hong Kong Surufatinib Oral angio-immuno kinase inhibitor that selectively inhibits tyrosine kinase activity associated with VEGFR and FGFR Solid tumors Dosing begun
Krystal Biotech Inc., of Pittsburgh KB-301 Collagen-rich connective tissue composed primarily of types I and III collagen fibrils Aesthetic skin conditions 2 repeated intradermal injections of KB-301 were well-tolerated and no safety signals were observed
Nascent Biotech Inc., of San Diego Pritumumab  Vimentin-binding monoclonal antibody Brain cancer Trial opened
Pfizer Inc., of New York PF-07321332 SARS-CoV2-3CL protease inhibitor COVID-19 Progressing to multiple ascending doses after completing single ascending doses in healthy adults
Proqr Therapeutics NV, of Leiden, the Netherlands QR-421a RNA therapy Usher syndrome Results from preplanned analysis of phase I/II Stellar trial in patients with Usher syndrome and nonsyndromic retinitis pigmentosa due to USH2A exon 13 mutations showed benefit on multiple measures of vision that moved in concordance, including visual acuity, visual fields and optical coherence tomography retinal imaging, after a single dose; company plans 2 pivotal trials by year-end
Theratechnologies Inc., of Montreal TH-1902 Peptide-drug conjugate Sortilin-positive solid tumors First patient dosed
Phase II
Basilea Pharmaceutica Ltd., of Basel, Switzerland Derazantinib Oral small-molecule FGFR inhibitor Intrahepatic cholangiocarcinoma Results of preplanned interim analysis in cohort 2 of Fides-01 study in patients with inoperable or advanced disease showed data met prespecified threshold for study to proceed to next stage as planned; criterion that at least 8 of 14 evaluable patients met primary endpoint of progression-free survival of at least 3 months was achieved
Brainstorm Cell Therapeutics Inc., of New York Nurown Neurotrophic factor-producing stem cells Progressive multiple sclerosis Top-line data showed study achieved primary endpoint of safety, with improvements observed in secondary endpoints spanning neurologic function, cognition and biomarkers; prespecified 25% improvements in the timed 25-foot walk and 9-hole peg test from baseline to 28 weeks were observed in 14% and 13% of Nurown-treated patients, respectively, vs. 0% of prespecified matched historical controls in the CLIMB registry; 38% of treated patients showed at least a 10-point improvement in the 12-item MS Walking Scale from baseline to week 28; 47% showed at least an 8-letter improvement across 28 weeks in the low contrast letter acuity test, and 67% showed at least a 3-point improvement in the symbol digit modality test 
Clover Biopharmaceuticals Inc., of Chengdu, China, and Dynavax Technologies Inc., of Emeryville, Calif. COVID-19 vaccine candidate S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum COVID-19 Dosed first participants in Spectra phase II/II trial testing 2-dose regimen given 21 days apart; study is expected to enroll 22,000+ adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa; interim analysis expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study
Durect Corp., of Cupertino, Calif. DUR-928 Endogenous sulfated oxysterol and an epigenetic regulator COVID-19 Terminated study testing treatment of acute organ failure in subjects infected with SARS-CoV-2 due to low enrollment
Daré Bioscience Inc., of San Diego, and Strategic Science & Technologies LLC (SST), of Cambridge, Mass. Sildenafil citrate cream PDE5 inhibitor Female sexual arousal disorder  Initiated phase IIb Respond study in pre- and peri-menopausal women; primary endpoint is improvement in localized genital sensations of arousal and reduction in distress related to condition; top-line data targeted for year-end 2021
Partner Therapeutics Inc., of Lexington, Mass. Leukine (sargramostim) Yeast-derived rhuGM-CSF Alzheimer's disease Alzheimer's & Dementia: Translational Research and Clinical Interventions published results from investigator-initiated study in people with mild to moderate disease that showed cognitive measures of memory improved compared to baseline by almost 2 points in 30-point MMSE (p=0.0074); after 3 weeks of treatment, Leukine-treated participants outperformed those who received placebo (p=0.0370)
Phase III
Eirgenix Inc., of Taipei, Taiwan EG-12014 (trastuzumab biosimilar) Erbb2 tyrosine kinase receptor inhibitor Breast cancer Trial met primary endpoint, showing equivalent efficacy to Herceptin (Roche Holding AG/Genentech Inc.) in pathologic complete response; preparations to begin for submissions of BLA to FDA, MAA to EMA and NDA to TFDA
Guerbet SA, of Villepinte, France Gadopiclenol MRI imaging agent Cancer 2 studies enrolling combined 560 participants met primary endpoints, showing diagnostic benefit at 0.05 mmol/kg during MRI based on superiority of exam vs. exam with no contrast agent and noninferiority to gadobutrol at 0.1 mmol/kg to visualize and detect lesions in CNS and other body areas
Myovant Sciences Ltd., of Basel, Switzerland, and Pfizer Inc., of New York Relugolix + estradiol + norethindrone acetate  GNRH receptor antagonist + estradiol agonist + progesterone receptor agonist Uterine fibroids Liberty randomized withdrawal study assessing treatment for up to 2 years met primary endpoint, with 78.4% of women who continued on combination therapy achieving sustained responder rate of menstrual blood loss < 80 mL through week 76 vs. 15.1% who discontinued treatment and initiated placebo at week 52 (p<0.0001); all 3 key secondary endpoints also met
Novo Nordisk A/S, of  Bagsvaerd, Denmark Semaglutide (subcutaneous) GLP1 receptor agonist Obesity Journal of the American Medical Association published findings from phase IIIa Step trial showing people dosed once-weekly at 2.4 mg following 20-week run-in had statistically significant additional mean weight loss of 7.9% to week 68 vs. those switched to placebo following run-in, who regained 6.9% for estimated treatment difference of -14.8% (p<0.0001); those on semaglutide 2.4 mg throughout 68-week trial achieved weight loss of 17.4%
Revive Therapeutics Ltd., of Toronto Bucillamine (repurposed formulation) Xanthine oxidase inhibitor COVID-19 infection Trial expanding to up to 50 U.S. sites and on track to meet planned enrollment goal of 1,000 participants in second quarter of 2021; no serious adverse events or safety concerns to date

Notes

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