Tanox Inc, Houston, has begun dosing a Phase 1 clinical trial of TNX-650, a humanized monoclonal antibody being evaluated as a potential treatment for moderate-to-severe asthma.
The trial is a randomized, double-blind, placebo-controlled, dose-escalation study of the safety, tolerability and pharmacokinetics of single doses of TNX-650 in healthy volunteers. A total of 32 subjects will be enrolled in four cohorts in the study, which is being conducted at a single site in the United States.
TNX-650 targets Interleukin 13 (IL-13). Preclinical studies indicate that IL-13 is a key mediator of asthma responses, including airway inflammation, obstruction, and hyper-reactivity. TNX-650, which has a mechanism of action unique from currently available asthma treatments, has the potential to be a therapeutic option for patients whose disease is not currently well controlled and for non-allergic asthmatics.
“Despite therapeutic advances, many asthmatics are still unable to effectively control their symptoms,” said Danong Chen, PhD, president and CEO of Tanox. “IL-13 plays a critical role in the development of asthma, and TNX-650 has been shown to be effective in blocking IL-13 function. If successful in the clinic, we believe TNX-650 could be another treatment option to help patients better manage their disease.”
Moderate-to-severe asthma affects approximately 35% of the estimated 17 million asthma patients in the United States.
Tanox is also evaluating the anti-IL-13 effect of TNX-650 as a potential treatment for Hodgkin’s lymphoma in an ongoing Phase 1 clinical trial.