Complexa Announces Successful Completion of Four Phase 1 Studies of CXA-10 and Planned Phase 2 Initiation in Multiple Orphan Indications during 2016
Emerging profile shows endogenous modulation of Nrf2 and NF-κB is well tolerated and has potential to reduce inflammation and reverse fibrosis
-New data in model of orphan renal disease FSGS presented during American Society of Nephrology's Kidney Week 2015
-Phase 1 development program with biomarkers supports Phase 2 initiation
PITTSBURGH and RADNOR, Pa., Nov. 12, 2015 /PRNewswire/ -- Complexa Inc., a clinical stage biopharmaceutical company focused on transforming the treatment of fibrosis and inflammatory diseases, today announced the successful completion of an extensive Phase 1 development program for its lead compound CXA-10. CXA-10 is an endogenous nitro-fatty acid (NFA) modulator of Nrf2 and NF-κB which impacts the core of fibrotic and inflammatory pathways. The four Phase 1 studies evaluating safety showed that CXA-10 in both intravenous and oral formulations was well tolerated in the 97 subjects dosed. Importantly, CXA-10 demonstrated activation of target gene expression and subsequent inhibition of key biomarkers of disease-related inflammation and fibrosis. Based on these trials, the company has begun preparations for Phase 2 studies in focal segmental glomerulosclerosis (FSGS) and pulmonary arterial hypertension (PAH), both targeted orphan indications associated with Nrf2 and NF-κB pathways.
"We and our investigators are impressed by the translational preclinical and Phase 1 data we have seen for CXA-10 as well as the differentiated therapeutic profile that the endogenous mechanism appears to provide," said Joshua Tarnoff, President and Chief Executive Officer of Complexa. "Our multi-pronged development program is focused on orphan indications with the potential for disease modification outcomes and rapid development paths."
The completed Phase 1 program included a Phase 1b trial of intravenous CXA-10 in renal patients, in whom CXA-10 target gene activation was demonstrated. In a second Phase 1b trial of oral CXA-10 in inflamed obese subjects, CXA-10 demonstrated positive effects on key protein and other biomarkers after repeat dosing. In all four studies, CXA-10 has been generally well tolerated without any serious adverse events demonstrating a favorable therapeutic index. As such, CXA-10 achieved its translational proof of concept in humans and is ready to be advanced to Phase 2 clinical trials.
"To have this degree of pharmacological proof of concept in humans after only two weeks of dosing and to demonstrate these effects at predicted doses provides great confidence for the robust conduct of Phase 2 trials in FSGS and PAH," said Complexa's Chief Medical Officer, Diane Jorkasky, MD.
New data were also recently presented during the American Society of Nephrology's Kidney Week 2015, held in San Diego, that reported renal and cardiovascular benefits of CXA-10 in a DOCA model of cardiovascular oxidative and inflammatory stress that mimics the orphan renal disease FSGS. The authors concluded that CXA-10 provided therapeutic benefit by acting on anti-inflammatory, anti-oxidant, and anti-fibrotic pathways. Also, in a separate ongoing study utilizing the 5/6ths nephrectomy model of renal injury, interim data support CXA-10's beneficial effects on renal hemodynamics and proteinuria that may make its therapeutic profile unique and highly differentiated. These data further support the rationale for the identified Phase 2 clinical strategy.
Based on the endogenous mechanism of CXA-10, the multitude of consistently replicated animal models, and the results seen to date in the modulation of key disease biomarkers in humans, the company has designed a Phase 2 development program focused on orphan indications driven by dysregulations of Nrf2 and NF-κB inflammation and fibrosis-related pathways. Complexa expects to initiate multiple trials during 2016, including:
Phase 2 trial of oral CXA-10 in FSGS
Phase 2 trial of oral CXA-10 in PAH
Phase 1B/2A trial of CXA-10 in Sickle Cell Crisis (IV) and Sickle Cell Disease (oral)
Complexa Inc. is a clinical stage biopharmaceutical company focused on transforming the treatment of fibrosis and inflammation-associated orphan diseases. Leveraging its differentiated endogenous nitro and ketofattyacid cell signaling technology, Complexa is advancing a platform of agents which target fibrosis and inflammation across multiple disease settings. Through nitro fatty acid signaling, Complexa's lead compound, CXA-10, modulates Nrf2 and NF-κB to regulate the inflammatory response and has been shown to reverse fibrosis in preclinical models of the heart, kidney, and lung. For more information, visit www.complexarx.com.
This press release contains "forward-looking statements" concerning the development of Complexa's products, the potential benefits and attributes of such products, and Complexa's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause our research and development programs, future results, working capital, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of clinical studies, enrollment in clinical studies, whether clinical study results for obtained to date will be predictive of future results, regulatory risks and uncertainties and other matters that could affect the commercial potential of our drug candidates and our ability to raise capital. These statements are made as of the date of this press release. Actual results may vary. Complexa undertakes no obligation to update any forward-looking statements for any reason.