(The ACR/ARHP meeting was held Nov. 5-9 in Chicago.) | ||||
Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
4SC AG (Planegg-Martinsried, Germany) |
Vidofludimus |
Designed to target IL-17 and dihydroorotate dehydrogenase |
Rheumatoid arthritis |
Phase IIb data demonstrated substantial anti-inflammatory activity of vidofludimus, with an ACR20 improvement of 50.8% vs. 44.8% in the control group (11/8) |
Abbott (Abbott Park, Ill.) |
Humira |
Anti-TNF drug; adalimumab |
Active nonradiographic axial spondyloarthritis |
Phase III data showed that more than twice as many patients receiving Humira compared to those receiving placebo achieved the primary endpoint of 40% improvement (11/8) |
Abbott (Abbott Park, Ill.) |
Humira |
Anti-TNF drug; adalimumab |
Ankylosing spondylitis |
Five-year results from an open-label extension show it resulted in a mean change from baseline of -0.6 in Bath Ankylosing Spondylitis Metrology Index (11/9) |
Amgen Inc. (Thousand Oaks, Calif.) |
Prolia |
Denosumab; a RANK ligand inhibitor |
Postmenopausal osteoporosis |
Phase III data showed that up to six years of continued Prolia treatment through both trials produced cumulative bone mineral density gains of 15.2% at the lumber spine and 7.5% at the total hip, compared with baseline (11/8) |
Ardea Biosciences Inc. (San Diego) |
Lesinurad |
URAT1 inhibitor |
Gout |
Phase IIb data showed a combination of lesinurad with allopurinol had consistent, sustained reductions in serum urate levels, with 90% of combination therapy patients at week 44 reaching the medically recommended target of sUA less than 6 mg/dL (11/8) |
BioCryst Pharmaceuticals Inc. (Research Triangle Park, N.C.) |
BCX4208 |
Next generation purine nucleoside phosphorylase inhibitor |
Gout |
Phase IIb data show that patients with gout who have failed to reach serum uric acid level of <6 mg/dL on allopurinol alone met the primary endpoint (11/9) |
Celgene International Sarl (Boudry, Switzerland) |
Apremilast |
Oral immunotherapy |
Ankylosing spondylitits |
Phase II data show it was associated with a trend to greater mean improvement from baseline compared with placebo in all parameters (11/9) |
Centocor Ortho Biotech Inc. (Horsham, Pa.) |
CNTO 136 |
Sirukumab; a subcutaneous human antibody directed against interleukin 6 |
Rheumatoid arthritis |
Phase II data showed treatment significantly improved rheumatoid arthritis signs and symptoms (11/8) |
Genentech Inc. (South San Francisco) |
Actemra |
Tocilizumab |
Rheumatoid arthritis |
Phase III data showed Actemra as a monotherapy resulted in 34.8% of patients achieving a DAS28 score at 24 weeks, comparable to the 40.4% rate in patients taking Actemra plus methotrexate (11/8) |
Neovacs SA (Paris) |
Kinoid |
Immunotherapy |
Lupus |
Data from a 28-patient study show that Kinoid reduced the gene dysregulation associated with the overexpression of INF-alpha (11/9) |
Novartis AG (East Hanover, N.J.) |
ACZ885 |
Canakinumab |
Active systemic juvenile idiopathic arthritis |
Pivotal Phase III data showed that 45% of children were able to substantially reduce their use of oral corticosteroids within 28 weeks of beginning treatment (11/8) |
Savient Pharmaceuticals Inc. (East Brunswick, N.J.) |
Krystexxa |
Pegloticase |
Gout |
A post-hoc analysis of pivotal Phase III data and an open-label extension confirmed that risk of infusion reactions and anaphylaxis could be mitigated by the monitoring of serum uric acid prior to each infusion and discontinuing Krystexxa in patients whose sUA levels rise above 6mg/dL (11/8) |
UCB SA (Brussels, Belgium) |
Cimzia |
Certolizumab pegol; pegylated anti-TNF drug |
Rheumatoid arthritis |
Findings from a post-hoc analysis suggest that disease activity response rates of Cimzia plus methotrexate as early as week 12 helped predict the effect on structural joint damage in patients with moderate to severe disease at one year (11/8) |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
VX-509 |
JAK3 inhibitor |
Rheumatoid arthritis |
Phase IIa data showed it significantly improved rheumatoid arthritis as measured by the proportion of people who achieved at least a 20% improvement in the signs and symptoms (11/8) |
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. # The date indicated refers to the BioWorld Today issue in which the news item can be found. |