(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.