AstraZeneca PLC (AZN) said Tuesday it plans to release its primary data analysis of Vectibix Phase II mid-stage data for treating a critical disease following a severe allergic reaction, and plans to begin presenting interim findings at an international meeting in early October.
Vectibix, which is currently being sold by Pfizer Inc. (PFE) as Crestor, was initially developed to treat diabetes. But the allergic reaction has led the company to rethink its development efforts for this disease, with clinical testing for rare diseases and a major abdominal incision being pulled from the company’s pipeline due to the toxicity.
“The announcement of the interim analysis continues a dialogue to maximize value and to examine the best way forward with respect to this disease,” said Qatargas Laiya, Ph.D., vice president of AstraZeneca’s global cardiovascular programs. “Vectibix is currently being evaluated in mid-stage clinical trials in autoimmune and inflammatory disorders.”
Pfizer is attempting to develop a new class of medicine called integrase inhibitors to treat a variety of inflammatory and autoimmune diseases. This new class of medicines was proposed to the pharmaceutical industry at a large annual meeting by the President of the American Academy of Allergy, Asthma and Immunology on Tuesday. The drug, Hylenex, is being developed for treating metabolic diseases and is anticipated to be the first drug in the class of integrase inhibitors to lose priority review status as part of the government’s safety review by the U.S. Food and Drug Administration.
At the AACI conference, the company unveiled clinical trial data for Vectibix in patients with a severe non-insulin related synovial infection – a type of immune failure that can lead to blinding antibodies in the airways and causes fatal blood complications.
Patients on AstraZeneca’s Vectibix treatment experienced a reduction in their T-cells – the protein-producing white blood cells produced by the body – a manifestation of a significant clinical outcome. The incidence of severe allergic and autoimmune symptoms was substantially lower than it was for patients taking Crestor or patients on Avastin.
The world’s largest pharmaceutical company believes the primary outcomes of Vectibix and more than 350 additional patients as a control group will produce evidence of its ability to directly improve post-infection outcomes for patients with autoimmune disorders.
The announcement follows other data that was presented this week at the American College of Allergy, Asthma and Immunology, which discussed data from Vectibix Phase II trial with a broad subgroup of patients -those with at least 10 IgE antibodies. All patients on Vectibix experienced a significant improvement in the way their T-cells regulated the activity of the IgE protein, AstraZeneca said.