Please login to the form below

Not currently logged in
Email:
Password:

Lilly stops tabalumab trial in arthritis on efficacy grounds

Will take a charge of around $20m to $35m

Lilly

Lilly has decided to call a halt to a phase III trial of its rheumatoid arthritis (RA) prospect tabalumab after an interim analysis suggested it would miss efficacy targets.

The trial, which was conducted in moderate-to-severe RA patients who had not responded to prior therapy with the disease-modifying anti-rheumatic drug (DMARD) methotrexat, is one of three pivotal studies Lilly is carrying out on the antibody.

The pharma company also said it would suspend enrolment in the two other phase III studies and an open-label extension study while it examines the data, but stressed there were no safety concerns with tabalumab.

Lilly will take a charge of around $20m to $35m in its fourth quarter results as a result of the decision to halt the study.

"The results of this study were unexpected given the data generated in earlier phase II clinical studies of tabalumab," said Eiry Roberts, Lilly's vice president of autoimmune product development.

"We will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development programme," she added.

Talamumab, also known as LY2127399, is an anti-B-cell activating factor (BAFF) human monoclonal antibody that is in development for RA as well as other autoimmune diseases such as systemic lupus erythematosus (SLE).

Lilly said its phase II trials in SLE will continue to enrol new patients as "there is no evidence to suggest that [the RA] efficacy results are indicative of potential efficacy in the lupus population".

Tabalumab is one of several candidates in late-stage development at Lilly for autoimmune conditions, along with anti-IL-17 antibody ixekizumab for psoriasis and psoriatic arthritis, and baricitinib – a JAK1 and JAK2 inhibitor being developed in collaboration with Incyte for RA, psoriasis and diabetic nephropathy.

The company needs new products to come through the pipeline as it faces patent expiration on its big-selling antidepressant Cymbalta (duloxetine) from next year, but has had a string of disappointments of late with solanezumab for Alzheimer's, Alimta (pemetrexed) in lung cancer and schizophrenia candidate pomaglumetad methionil.

14th December 2012

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Atlantis Healthcare

Atlantis Healthcare is a global leader in optimising patient self-management. Established in 1996, we design, develop and implement scalable solutions...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics