News


Celtaxsys Has Regulatory Clearance to Begin Phase 2 Trial of Oral CTX-4430 Anti-Inflammatory Therapy for Moderate to Severe Acne Vulgaris – Recruitment of Patients to Commence Immediately

ATLANTA, April 7, 2015 — Atlanta-based pharmaceutical company Celtaxsys, Inc. announced today that it has received regulatory
clearance to commence the phase 2 trial for its flagship compound, CTX-4430, in patients with moderate to severe facial
acne vulgaris. This approval triggers site engagement to screen and enroll appropriate patients with acne henceforth. This
proof-of-concept study will assess the efficacy and safety of 100 mg CTX-4430 administered as a once daily oral dose for 12
weeks. Effects on inflammatory lesion counts will serve as the primary efficacy outcome. Effects on non-inflammatory lesion
counts as well as an Investigator’s Global Assessment (the physician’s overall assessment of the patient’s disease) will also be
studied.
“The regulatory clearance for this trial in New Zealand marks the entry of CTX-4430 into Phase 2 development, with other Phase 2
studies soon to follow,” said Greg Duncan, Celtaxsys CEO. “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.”
This phase 2 acne vulgaris study will be conducted at approximately 10 sites in Australia and New Zealand with Dr. Lynda J
Spelman, MBBS FACD as the Principal Investigator.
Sanjeev Ahuja, MD MBA FACP, Celtaxsys Chief Medical Officer explained, “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.”
Additional information regarding this clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT02385760.
About acne vulgaris: Acne vulgaris (AV), or simply acne, is an extremely common skin disease affecting an estimated 650 million
worldwide and starts most often in adolescents during the onset of puberty. AV is characterized by the proliferation of inflammatory
and non-inflammatory skin lesions, hyperactive sebaceous glands, and permanent skin scarring in some cases. Moderate to
severe AV can reduce the quality of life of those afflicted due to negative effects on a person’s self-esteem and the social stigma
associated with the disease.
About CTX-4430: CTX-4430 is a once-daily oral drug candidate currently undergoing clinical trials for inflammatory diseases. It is
a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTAH4), the key enzyme in the production of the potent inflammatory
mediator Leukotriene B4 (LTB4). LTA4H and LTB4 have been strongly implicated in the pathogenesis of many diseases involving
inflammation, including acne.
About Celtaxsys: Celtaxsys, Inc. is a privately-held clinical stage drug discovery and development company focused on developing
new medicines to treat patients affected by severe inflammatory mediated diseases. The company is building a sustainable
pipeline of first-in-class immuno-modulating drugs, including its flagship CTX-4430 compound. For more information, visit
www.celtaxsys.com.