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news.US-based pharmaceutical firm Celtaxsys has secured regulatory clearance in New Zealand to start the Phase II trial of its once-daily oral drug candidate, CTX-4430, to treat patients with moderate to severe facial acne vulgaris.
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The Phase II acne vulgaris trial will be conducted at about ten sites in Australia and New Zealand with Dr Lynda Spelman as the principal investigator.
The trial is designed to evaluate the efficacy and safety of 100mg CTX-4430 administered as a once daily oral dose for 12 weeks.
Celtaxsys CEO Greg Duncan said: "The regulatory clearance for this trial in New Zealand marks the entry of CTX-4430 into Phase II development, with other Phase II studies soon to follow.
"The dermatology community has consistently supported our hypothesis regarding the therapeutic benefits of an anti-inflammatory agent, either as a complement to existing therapeutic regimens or as a possible alternative to reduce the reliance on chronically administered antibiotics or other options that may be effective, but have significant side effects, including toxicity associated with long term usage.
"We are excited to explore the promise of CTX-4430 as a once daily oral treatment for inflammatory diseases, starting with acne, and we are privileged to work with the many of the world’s top dermatologists to design and execute this ground breaking program which will start enrolling patients shortly."
The company said that effects on inflammatory lesion counts will serve as the primary efficacy outcome, while effects on non-inflammatory lesion counts as well as an Investigator’s Global Assessment will also be examined.
Celtaxsys chief medical officer Sanjeev Ahuja said: "The need for innovative treatments for acne vulgaris is high, especially for anti-inflammatory treatments like CTX-4430 that are not based on chronic antibiotic therapy or retinoids.
"In addition, having a once daily oral treatment like CTX-4430 potentially provides improved convenience for patients as well as an opportunity to treat the disease from the depths of the skin, where it starts."
CTX-4430 is a new small molecule inhibitor of Leukotriene A4 Hydrolase (LTAH4), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4).