Alder BioPharmaceuticals, Inc. recently announced that its therapeutic antibody clazakizumab (ALD518) has met the primary endpoint of a Phase 2b clinical trial in adult patients with rheumatoid arthritis (RA). The results of this clinical trial will be presented at an upcoming scientific meeting.
RA is an autoimmune disease that causes chronic inflammation and pain in the joints and other parts of the body due to an overreaction of the body’s own immune system. It is estimated that in the United States approximately 2.4 million individuals, mainly women, suffer from the disease.
There is strong evidence supporting that an early aggressive treatment delays the irreversible structural damage to the joints often seen in RA patients. The American College of Rheumatology has established that RA treatment should aim at disease remission, and if this cannot be achieved, then it should strive to achieve a low disease activity. The leader of the RA market in terms of treatment is a class of drugs that target tumor necrosis factor alpha (anti-TNFs). However, low rates of disease remission have been observed with these anti-TNFs and the patient’s response is usually not durable.
Alder’s clazakizumab is a therapeutic, humanized, monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6 (IL-6) potentially leading to a reduction in inflammation, pain, swelling and joint tissue destruction often experienced by RA patients. Clazakizumab has now been evaluated in terms of safety and efficacy in a Phase 2b, dose-ranging clinical trial in 140 patients with moderate to severe RA and who have had a poor response to TNF inhibitors.
Clazakizumab was found to be an effective therapy for RA at both doses tested (5 and 25 mg) in comparison to the placebo control as assessed by changes in Disease Activity Score in 28 joints (DAS28). Clazakizumab was also found to be well tolerated by the patients with no associated adverse events.
“These positive safety and efficacy findings in patients with rheumatoid arthritis provide additional support for the promise of clazakizumab as we seek a new partner to continue developing this monoclonal antibody for the treatment of autoimmune and inflammatory diseases,” concluded the President and Chief Executive Officer of Alder, Dr. Randall C. Schatzman in the press release.