Celtaxsys Presents Clinical Data on Oral CTX-4430 at 2015 European Cystic Fibrosis Conference: Positive Impacts on Key Biomarkers in Patients with CF

Print 11 June 2015

Atlanta, GA. (June 10, 2015) – Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from inflammatory diseases, including those with rare and orphan inflammatory diseases, announced today data from Phase 1 clinical trials of CTX-4430 will be presented at the 2015 Meeting of the European Cystic Fibrosis Society in Brussels on Friday, Jun 12, 2015.

The poster presentations are the following:

- A Phase 1 Clinical Study of CTX-4430 in Cystic Fibrosis Patients (Poster #126)

- Comparative Pharmacokinetics and Pharmacodynamics of CTX-4430 in Healthy Volunteers and CF Patients (Poster #127)

- A Phase 1 Drug-Drug Interaction Study of CTX-4430 Assessing CYP3A4 Induction (Poster #129)

These posters will be presented under the “New Therapies” section on Friday, Jun 12. There will be a guided poster tour from 2-3 pm CET.

“We believe the data from our Phase 1 trials of once daily oral CTX-4430 clearly establish proof of mechanism by showing encouraging correlated reductions in both blood and sputum biomarkers of inflammation in CF patients after just 15 days of treatment. In particular, reductions in LTB4 levels in both blood and sputum were accompanied by reductions in sputum neutrophil counts, elastase and DNA, all important biomarkers of CF associated lung inflammation. Importantly, these apparent reductions in lung inflammation did not result in changes in sputum microbiology. Taken together the Phase 1 data show that CTX-4430 has the potential to improve clinical outcomes for patients with CF by addressing the underlying inflammation and we hope to demonstrate this in an upcoming Phase 2 study,” said Greg Duncan, Chief Executive Officer of Celtaxsys. “Also, the fact that CTX-4430 does not induce CYP3A4 shows that the molecule can be administered without adversely impacting the levels of some of the newly introduced drugs for patients with CF,” added Sanjeev Ahuja, MD, Celtaxsys Chief Medical Officer.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system and impacts about 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, the result of which causes the body to accumulate excessive levels of unusually thick mucus in the lungs. This excessive sticky mucus in the lungs is a site for infections that can require hospitalization. In the pancreas and GI tract CFTR protein dysfunction results in malabsorption of nutrients and sometimes intestinal blockage. Respiratory distress in CF, defined as acute difficulty in breathing, infection and/or hospitalization, is most commonly related to lung infection and inflammation induced lung tissue damage attributable to an overwhelming and dysfunctional response by dysregulated neutrophils. Treatment of this lung inflammation is, therefore, thought to be key to improving CF patient’s lung health and wellbeing. For more information on cystic fibrosis, go to www.cff.org.

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 cystic fibrosis.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing medicine to treat patients suffering from serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is CTX-4430. Our follow-on molecules enable new intellectual property and exhibit differentiated properties that enable optimization for alternate routes of administration. For more information, visit www.celtaxsys.com.

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