Company Product Description Indication Status
Phase I
ADC Therapeutics SA, of Lausanne, Switzerland Camidanlumab tesirine (ADCT-301) CD25-targeted antibody-drug conjugate Advanced solid tumors First patient dosed in phase Ib trial testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.)
Aptevo Therapeutics Inc., of Seattle APVO-436 Anti-CD123 x anti-CD3 bispecific antibody Acute myeloid leukemia and myelodysplastic syndrome Based on preliminary data from phase I/Ib study, a patient in cohort 6 has shown complete remission; bone marrow masts decreased from 29% at screen to 6% after first cycle of treatment and 0% after second cycle, and platelet count and absolute neutrophil count met complete remission criteria
Sheba Medical Center, of Ramat Gan, Israel, and the Israel Institute for Biological Research Brilife Vaccine COVID-19 Vaccine administered to first volunteer in phase I/II trial
Phase II
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Voclosporin ophthalmic solution Calcineurin inhibitor; IL-2 receptor antagonist Dry eye syndrome Top-line data showed phase II/III Audrey study did not achieve statistical significance on its primary endpoint of a 10 mm or greater improvement in the Schirmer Tear Test at 4 weeks between active dose groups vs. vehicle; Aurinia is suspending the development program based upon those results
Biogen Inc., of Cambridge, Mass. BIIB-059  Anti-BDCA2 monoclonal antibody Systemic lupus erythematosus 23-week SLE portion of Lilac study (part A) showed treatment associated with statistically significant reduction in total active joint count; change in baseline of 3.4 in total active joint count in those receiving 450 mg given subcutaneously every 4 weeks with an additional dose at week 2 vs. placebo (p=0.037); study also met secondary endpoint of SLE Responder Index, resulting in overall reduction in disease activity vs. placebo (56.77% SRI-4 response vs. 30.42%; p=0.003)
Edesa Biotech Inc., of Toronto EB-01 sPLA2 inhibitor Chronic allergic contact dermatitis Completed enrollment of more than 50% of the patients planned for the first cohort
Horizon Therapeutics plc, of Dublin Krystexxa (pegloticase injection) Uricase stimulator Chronic gout refractory to conventional therapies When used concomitantly with an immunomodulator, showed improved response rates vs. Krystexxa monotherapy, with 86.4% of patients (19 of 22) receiving co-therapy achieving serum uric acid ≤ 6 mg/dL through month 3, the primary study endpoint, compared to 40% (4 of 10) in monotherapy arm
Prometic Biosciences Inc., of Laval, Quebec PBI-4050 Stimulation of GPR40 and inhibition of GPR84 Alström syndrome Phase II/III study terminated early due to redeployment of study site staff during COVID-19 pandemic
Phase III
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 Genetically targeted therapeutic  Alcohol use disorder Completed 40% of the expected patient screenings and enrolled more than 25% of the planned enrollment; full enrollment expected in the second quarter of 2021 with data expected in the fourth quarter of 2021 or earlier
Bristol Myers Squibb Co., of New York Deucravacitinib (BMS-986165) Tyrosine kinase 2 inhibitor Moderate to severe plaque psoriasis In the POETYK PSO-1 study, at week 16, more patients taking deucravacitinib achieved Psoriasis Area and Severity Index 75 and a static Physician’s Global Assessment score of clear or almost clear than those taking placebo or those taking Otezla (apremilast, Amgen Inc.); data to be presented at a future medical meeting
Celltrion Group, of Incheon, South Korea CT-P17 Citrate-free adalimumab biosimilar Rheumatoid arthritis ACR20 response rate at week 24 was 82.7% for both CT-P17 and reference adalimumab; similar results were seen on ACR20/50/70 response rates, mean DAS28, clinical disease activity index and simplified disease activity index and EULAR response
Concert Pharmaceuticals Inc., of Lexington, Mass. CTP-543 Janus kinase inhibitor Moderate to severe alopecia areata Started the Thrive-AA1 study comparing 2 dose levels to placebo; primary endpoint is patients achieving a Severity of Alopecia Tool score ≤ 20 at 24 weeks
GW Pharmaceuticals plc, of Carlsbad, Calif. Nabiximols  Extracts of the cannabis Multiple sclerosis-associated spasticity Started study measuring spasm frequency over 12 weeks in 446 patients
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Exportin 1 inhibitor  Advanced unresectable dedifferentiated liposarcoma In the Seal study, Xpovio reduced the risk of disease progression or death by approximately 30% compared to placebo
Outlook Therapeutics Inc., of Monmouth Junction, N.J. Lytenava (bevacizumab-vikg) Monoclonal antibody targeting vascular endothelial growth factor Wet age-related macular degeneration Completed enrollment of 195 patients in the Norse Three study
Phase IV
Eli Lilly and Co., of Indianapolis, and Incyte Corp., of Wilmington, Del. Olumiant JAK inhibitor   Rheumatoid arthritis Post-hoc analysis showed 27.5% of inadequate responders to conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and 18.4% of patients who had an inadequate response to biologic DMARDs had Simple Disease Activity Index ≤11 after 120 weeks

Notes

For more information about individual companies and/or products, see Cortellis.