US-based clinical stage drug firm Celtaxsys has completed the Phase I clinical trial of its lead clinical stage drug candidate, CTX-4430 to treat patients with cystic fibrosis (CF) lung disease.
The company’s Australian subsidiary, Celtaxsys Aus, has carried out the first of two clinical trials in its first phase programme.
In the trial, the drug was administered orally to healthy volunteers in increasing doses of around 200mg/day for two weeks and was also well-tolerated at all doses.
Celtaxsys expects to release the results of the trial at the 27th Annual North American Cystic Fibrosis Conference in October 2013.
Celtaxsys CMO Ed Philpot said the first-in-human clinical trial assessed safety in 96 subjects.
“These results support the continued clinical development of CTX-4430 as a once-daily oral treatment for pulmonary inflammation in CF,” Philpot said.
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During the trial, the CTX-4430 also showed substantial pharmacokinetic and pharmacodynamic properties, according to the company.
Celtaxsys CSO Eric Springman said the 100mg dose achieved maximal effect on its intended target, Leukotriene A4 Hydrolase, for the entire 24-hour period between doses.
“Having a biomarker to directly probe mechanism of action provides us with a much better understanding of the relationship between dose and effect and will be a tremendous help in the further clinical development of CTX-4430,” Springman said.
The drug will now progress into a Phase IB trial to assess the safety and pharmacokinetics of once-daily oral treatment for lung disease in CF patients.
CTX-4430 is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in production of the potent inflammatory mediator Leukotriene B4 (LTB4).
Image: Clubbing in the fingers of a cystic fibrosis (CF) sufferer. Photo: courtesy of Jerry Nick, M.D.