Company Product Description Indication Status
Phase I
Kintor Pharmaceutical Ltd., of Suzhou, China Pyrilutamide  Androgen receptor antagonist Acne vulgaris Started dosing patients in the phase I/II study testing the safety, tolerability, pharmacokinetics and efficacy of pyrilutamide
Phase II
EMD Serono, a unit of Merck KGaA, of Darmstadt, Germany Evobrutinib  Bruton’s tyrosine kinase inhibitor Relapsing multiple sclerosis A post-hoc analysis showed treatment with evobrutinib significantly reduced blood neurofilament light chain levels compared to placebo; evobrutinib decreased CXCR3+ memory B-cell transmigration through human CNS endothelial cell monolayers; in the open-label extension, evobrutinib was detected in the cerebrospinal fluid of all 9 patients analyzed with levels evobrutinib distribution into cerebrospinal fluid
Horizon Therapeutics plc, of Dublin Uplizna (inebilizumab-cdon) Monoclonal antibody targeting CD19 Anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder In the open-label extension of the phase II/III N-Momentum study, over at least 4 years, 87.7% of the 165 patients who received Uplizna during the randomized phase and 83.4% of the 51 patients who originally received placebo remained attack-free
Horizon Therapeutics plc, of Dublin Tepezza (teprotumumab-trbw) Monoclonal antibody targeting insulin-like growth factor-1 receptor Thyroid eye disease Pooled data from the phase II and phase III studies published in The Lancet Diabetes & Endocrinology showed Tepezza improved proptosis in 87% of patients, diplopia in 66% of patients and ophthalmic composite outcome in 92% of patients 7 weeks after the last dose; post-hoc analysis showed 81% of Tepezza patients and 44% of placebo patients met the composite ophthalmic outcome at week 24
Implicit Bioscience Ltd., of Brisbane, Australia IC-14 Monoclonal antibody targeting CD14 COVID-19 CaTT study sponsored by the U.S. National Institute of Allergy and Infectious Diseases started enrolling patients; study will test the safety and efficacy of IC-14 plus Veklury (remdesivir, Gilead Sciences Inc.); primary endpoint is time to clinical recovery; secondary outcome measures include days alive and free of respiratory failure; data expected in early 2022
Quantum Leap Healthcare Collaborative, of San Francisco, and Takeda Pharmaceutical Co. Ltd., of Tokyo  Firazyr (icatibant) Bradykinin type 2 receptor agonist Critically ill COVID-19 Data monitoring committee recommended concluding the icatibant arm of the I-SPY COVID study because the first 95 patients met the predefined futility criterion of a probability of 90% or more that the drug will offer no more than a 50% benefit compared to standard treatment of dexamethasone and Veklury (remdesivir, Gilead Sciences Inc.)
Phase III
Biogen Inc., of Cambridge, Mass. Tysabri (natalizumab) Monoclonal antibody targeting alpha4-beta1 integrin Multiple sclerosis Tysabri produced statistically significant improvements in 10 of 12 domains of Quality of Life in Neurological Disorders compared to 8 of 12 domains for Ocrevus (ocrelizumab, Roche Holding AG); Tysabri was better than Ocrevus for satisfaction with social roles and activities (p=0.02), participation in social roles and activities (p=0.0001) and emotional and behavioral dyscontrol (p=0.01); extended interval dosing produced comparable real-world effectiveness on quantitative magnetic resonance imaging (MRI) outcomes compared to standard interval dosing (p>0.05 for all MRI outcomes)
Roche Holding AG, of Basel, Switzerland Ocrevus (ocrelizumab) Monoclonal antibody targeting CD20-positive B cells Multiple sclerosis Interim analysis of the phase IIIb Ensemble study showed 85% of patients with relapsing-remitting MS achieved no evidence of disease activity after 48 weeks; Expanded Disability Status Scale score improved from 1.71 at baseline to 1.55 after 48 weeks (p=0.002); a post-hoc analysis of the phase III Oratorio study showed the atrophied T2-lesion volume was 319 mm3 for primary progressive MS patients treated with Ocrevus at 120 weeks compared to 366 mm3 for placebo (p<0.015)
TG Therapeutics Inc., of New York Ublituximab Glycoengineered monoclonal antibody targeting CD20 Multiple sclerosis Annualized relapse rate was 0.076 for ublituximab compared to 0.188 for Aubagio (teriflunomide, Sanofi SA) in the Ultimate I study (p<0.0001) and 0.091 for ublituximab compared to 0.178 for Aubagio in Ultimate II (p=0.0022); in Ultimate I, 44.6% of ublituximab treated patients achieved no evidence of disease activity (NEDA), a 198% improvement over Aubagio (p<0.0001); in Ultimate II, NEDA rate was 43% for ublituximab, a 277% improvement over Aubagio (p<0.0001)

Notes

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