Celtaxsys Raises $45M For Novel Anti-inflammatory CF Drug Phase 2 Research

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by Charles Moore |

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The lead drug candidate under development by Celtaxsys — an Atlanta, Georgia based clinical-stage development company focused on novel therapeutics for treating inflammatory disease through regulation of immune cell migration and activation — is CTX-4430, described as a potent, oral, once-daily, small-molecule LTA4 Hydrolase (LTA4H) inhibitor that shows promise as a potential treatment for Cystic Fibrosis and other inflammatory diseases.

LTA4H is the key enzyme in production of the powerful inflammation promoter Leukotriene B4 (LTB4), with both strongly implicated in pathogenesis of pulmonary inflammation associated with Cystic Fibrosis (CF) — a chronic disease that affects the lung and digestive systems and impacts 70,000 patients worldwide, 30,000 of which live in the US alone. CF is caused by genetic deficiencies leading to abnormal protein functioning, the result of which causes the body to produce excessive levels of unusually thick mucus in the lungs, pancreas, and GI tract. This mucous clogs the lungs, leading to life-threatening infections and hospitalizations, as well as altering the digestive system’s ability to break down and absorb food. 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 neutrophils.

Celtaxsys says CTX-4430 has shown to be effective in several CF-related, pre-clinical and clinical models and has been well tolerated in healthy volunteers and CF patients, and the drug candidate will also advance into a phase II trial in moderately severe acne, a disorder characterized by a high expression of LTB4, which can at times create an over-activation of neutrophil immune response and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including Cystic Fibrosis, COPD, Multiple Sclerosis, Irritable Bowel Disorders and a variety of dermatologic diseases.

CTX-4430 is one of a series of candidates covered under composition of matter patents being developed by Celtaxsys, which announced this week that it has secured $40M in Series D financing led by Domain Partners VIII. Additional investors in the financing include Lumira Capital, RMI Partners, Masters Capital Management and the Georgia Research Alliance Venture Fund.

The corporate financing will be supplemented by a $5M grant from the Cystic Fibrosis Foundation Therapeutics (“CFFT”), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation (“CFF”). The grant will help fund Celtaxsys’s CTX-4430 Phase 2 trial. CTX-4430 has been granted Orphan Drug Designation in both the US and the EU.

duncanG“The proceeds from this financing, led by top-tier biotechnology investors, speaks to the investment community’s support for developing innovative anti-inflammatory medicines for patients diagnosed with orphan diseases. We believe CTX-4430’s ability to reduce neutrophil elastase in the airways of CF patients has the potential to preserve lung function in CF patients, irrespective of patient-specific CF gene mutation,” comments Celtaxsys President and CEO Greg Duncan.

“Although new therapies have markedly improved the outlook for patients with CF over the past few decades, the effects of chronic inflammation in the lungs is still the primary cause of early death. An effective anti-inflammatory therapy for CF patients is sorely needed,” says Michael Konstan, MD, Vice Dean for Translational Research at Case Western Reserve University School of Medicine and Vice Chair for Clinical Research at UH Rainbow Babies & Children’s Hospital, Cleveland, in a release. “Early results demonstrating that CTX-4430 can reduce elastase and sputum neutrophils are promising. We look forward to seeing how CTX-4430, in combination with the other treatments CF patients are taking, can reduce lung inflammation in the upcoming Phase 2 trial with the ultimate goal of improving the quality of life and survival of CF patients.”

In conjunction with the financing, Nicole Vitullo, Partner at Domain Associates, Gerry Brunk, Managing Director at Lumira Capital, and Maxim Gorbachev,

Partner at RMI Partners will join the Celtaxsys’ board of directors at this important juncture for the Company.

“We are delighted to be adding substantial life-sciences expertise to our board as we position ourselves to advance our lead candidate into Phase 2 and our broader Leukotriene A4 Hydrolase inhibition platform to treat patients with a variety of inflammatory diseases”, commented Daniel Perez, Chairman of the Celtaxsys Board of Directors.

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Glossary of Terms:

[wikibox lang=”en”]Leukotriene-A4 hydrolase[/wikibox]

Case Western Reserve University School of Medicine

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Case Western Reserve University School of Medicine
Domain Associates
Lumira Capital
RMI Partners