Company Product Description Indication Status
Phase I
Alzecure Pharma AB, of Stockholm ACD-856 Brain-derived neurotrophic factor ligand modulator; NGF/TRKA receptor modulator Alzheimer's disease Study showed good pharmacokinetic profile with shorter human half-life than predecessor ACD-855 and suitability as oral treatment
Celltrion Healthcare Co. Ltd., of Incheon, South Korea Remsima SC (infliximab biosimilar, subcutaneous) TNF-alpha ligand inhibitor/binding agent Rheumatoid arthritis Study showed no impact of BMI on study drug response in those with active RA; mean change from baseline of Disease Activity Score 28 at week 54, duration of low disease activity up to week 54  and good or moderate EULAR responder rates showed no statistically significant differences among those under/normal weight, overweight or obese
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa. INO-4800 COVID-19 spike glycoprotein modulator COVID-19 infection With International Vaccine Institute and Seoul National University Hospital, preparing to start phase I/II trial in Korea in June 2020; 2-stage trial will begin in 40 healthy adults ages 19-50 and expand to another 120 people ages 19-64
Kezar Life Sciences Inc., of South San Francisco KZR-616 Proteasome inhibitor Systemic lupus erythematosus  Updated results from phase Ib portion of Mission study showed improvements across 7 measures of disease activity; 2 of 2 participants with lupus nephritis showed >50% reduction in proteinuria and reductions in SLEDAI and anti-double-stranded DNA antibody levels
Obseva SA, of Geneva Linzagolix GNRH receptor antagonist Adenomyosis Patient report from open-label study (n=9) showed cessation of bleeding by week 12 of treatment with study drug at 200 mg; pelvic pain improved, anemia resolved and MRI showed shrinkage in uterine volume (to 290 cm3) with regression of adenomyotic lesions; cessation of bleeding and alleviation of symptoms continued during subsequent 12-week course with 100 mg and persistence of effect was seen 8 weeks following treatment completion; data reported in Fertility and Sterility 
Phase II
Biogen Inc., of Cambridge, Mass. BIIB-059 C-type lectin domain protein 4C inhibitor Cutaneous lupus erythematosus CLE part of Lilac study met primary endpoint (p<0.001), showing dose response of study drug on % change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 16; those with CLE dosed at 50 mg, 150 mg and 450 mg showed reductions in CLASI-A scores of 38.8% (p=0.015), 47.9% (p<0.001) and 42.5% (p=0.001), respectively, vs. 14.5% with placebo; for secondary endpoint of CLASI-50 response, statistical significance was achieved at 450 mg, with 23.3% (p=0.024) more than placebo
Heron Therapeutics Inc., of San Diego HTX-011 (bupivacaine + meloxicam) Cyclooxygenase 2 inhibitor; sodium channel inhibitor Pain Data from phase IIb Study 209 in primary unilateral total knee arthroplasty, which showed statistically significant reductions in pain intensity following surgery, were published online by The Journal of Arthroplasty
Irlab Therapeutics AB, of Stockholm Mesdopetam (IRL-790) Dopamine D3 receptor antagonist Parkinson's disease Phase IIb/III study in levodopa-induced dyskinesia expected to enroll about 140 individuals evenly distributed across 3 dose levels of study drug and placebo for 3-month study duration; primary outcome measure is change in daily hours of "on" time without dyskinesia as assessed with 24-hour patient home diaries
Phase III
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) JAK inhibitor Moderately to severely active rheumatoid arthritis In the Select-Compare study at 72 weeks, Rinvoq plus methotrexate (MTX) produced an ACR20, ACR50 and ACR70 of 64%, 51% and 38%, respectively, compared to 53%, 38% and 25%, respectively, for Humira (adalimumab) plus MTX; in the Select-Monotherapy study at 84 weeks, switching from MTX to 30 mg of Rinvoq at week 14 produced  an ACR20, ACR50 and ACR70 of 90%, 68% and 50%, respectively, compared to 96%, 78% and 66%, respectively, for patients on Rinvoq the entire time
Celltrion Healthcare Co. Ltd., of Incheon, South Korea Remsima SC (infliximab biosimilar, subcutaneous) TNF alpha ligand inhibitor/binding agent Rheumatoid arthritis 1-year data from pivotal trial assessing correlation between magnitude of anti-drug antibody (ADA) positivity and clinical outcomes showed administration of SC formulation did not result in greater incidence of ADA vs. I.V. Remsima and no clinical differences between formulations were observed
Follica Inc., of Boston FOL-004
FGF receptor agonist; FGF-9 ligand

Following end-of-phase II meeting with FDA, phase III trial, expected to begin by year-end, plans to enroll about 280 participants, with co-primary endpoints of visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale
Gilead Sciences Inc., of Foster City, Calif., and Galapagos NV, of Mechelen, Belgium Filgotinib JAK1 inhibitor Moderately to severely active rheumatoid arthritis At 52 weeks in the Finch1 study in patients who had an inadequate response to methotrexate (MTX), a greater proportion of patients treated with filgotinib 200 mg achieved low disease activity (DAS28(CRP) ≤3.2) and clinical remission (DAS28(CRP) <2.6) compared with patients treated with Humira (adalimumab, Abbvie Inc.) (nominal p<0.05); in the Finch3 study at 52 weeks in MTX-naive patients, higher proportions of patients taking filgotinib 200 mg plus MTX, 100 mg plus MTX and filgotinib 200-mg monotherapy achieved ACR20 (nominal p<0.001, p<0.01 and p<0.001), ACR50 (nominal p<0.001, p<0.01 and p<0.01), ACR70 (nominal p<0.001, p<0.05, p<0.01) and disease remission (nominal p<0.001 for all 3 arms) compared with patients receiving MTX monotherapy
Hutchison China Meditech Ltd., of London Fruquintinib  VEGFR 1/2/3 inhibitor Advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after progression on first-line chemotherapy After an interim data review, the independent data monitoring committee recommended the Frutiga study continue
Novartis AG, of Basel, Switzerland Cosentyx (secukinumab) Monoclonal antibody targeting IL-17A Axial spondyloarthritis In the Prevent study, ASAS40 at week 16 was 41.5% for Cosentyx compared to 29.2% for patients treated with placebo (p<0.05) and at week 52 was 35.4% for Cosentyx compared to 19.9% for placebo (p<0.05)
Novo Nordisk A/S, of Bagsvaerd, Denmark Subcutaneous semaglutide 2.4 mg GLP-1 receptor agonist Weight management Headline results showed phase IIIa Step 1 trial met both primary endpoints; in all people randomized, a statistically significant and superior reduction in body weight was achieved with semaglutide vs. placebo after 68 weeks (weight loss of 14.9% vs. 2.4%); 86.4% of those who received semaglutide reached a weight loss of 5% or more after 68 weeks, compared to 31.5% with placebo
Pfizer Inc., of New York Abrocitinib JAK1 inhibitor Moderate to severe atopic dermatitis Results of the Jade Mono-2 study published in JAMA Dermatology showed 200-mg abrocitinib produced an investigator global assessment of 0 or 1 and a 2-point or greater improvement in 38.1% of patients compared to 9.1% of patients on placebo; EASI-75 response rate was 61% for abrocitinib compared to 10.4% for placebo


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

No Comments