Complexa Initiates Phase 1B Study of CXA-10 in Acute Kidney Injury

-First Phase 1A Clinical Trial in healthy people completed successfully

-IND filing for Oral CXA-10 in Chronic Kidney Injury on track for 2014

-Complexa initiates strategic plans to further develop next generation compounds in Pulmonary and CNS

PITTSBURGH--()--Complexa, Inc., an inflammatory and fibrosis oriented biopharmaceutical company, announced today the initiation of a Phase 1B clinical study of its lead IV product candidate CXA-10 for the treatment of acute kidney injury related to the administration of contrast imaging agents. CXA-10 is the first of a novel class of endogenous signaling agents that broadly target the body’s inflammatory and fibrosis related pathways.

“The IV trials are key to informing certain development strategies for the Oral CXA-10 clinical program for chronic kidney injury. We intend to begin these in the first quarter, with a target for Phase 2 by the end of 2015.”

The Phase 1B study initiation is based on the successful completion of a Phase 1A safety study. The data confirmed preclinical studies and showed that CXA-10 was very well tolerated in the obese and healthy men and women studied.

“Data from the CXA-10 Phase 1A clinical trial gave us further confidence in the compound’s safety and yielded valuable pharmacokinetic data,” said Josh Tarnoff, Complexa President and CEO. “Complexa also intends to file an IND for oral CXA-10 for chronic kidney disease by the end of 2014. With a successful regulatory filing for the Oral Program, Complexa will be in position to further develop key chronic applications for CXA-10.”

Complexa Chief Medical Officer, Diane Jorkasky, MD further commented, “The IV trials are key to informing certain development strategies for the Oral CXA-10 clinical program for chronic kidney injury. We intend to begin these in the first quarter, with a target for Phase 2 by the end of 2015.”

Complexa identified kidney injury as the lead proof-of-technology indication due to the significant unmet need in this patient population.

Leveraging extensive pre-clinical data, Complexa also announced the initiation of programs for pulmonary and neurodegenerative diseases with compounds from its extensive library of next generation oral human pathway signaling agents. Complexa’s nitro-fatty-acid and related compounds have demonstrated significant reduction in pulmonary fibrosis and inflammation, key components in most pulmonary diseases. In addition, many neurodegenerative diseases are related to defects in certain anti- and pro-inflammatory pathways. These same pathways are the direct targets of the actions of Complexa’s compounds thus making them ideal candidates for the treatment of these debilitating diseases.

About Complexa

Complexa, Inc. is a platform biopharmaceutical company researching and developing endogenous human cell signaling technologies targeting an array of prevalent inflammatory and fibrosis related diseases. The company’s proprietary technology involves the synthesis and therapeutic applications of endogenous nitro-fatty acids (NFAs) and additional structure/function-related mediators that are designed to treat various diseases. NFAs are cell-signaling agents that regulate major inflammatory signaling pathways (e.g., Nrf2, NFkB and HSF). Capitalizing on the identification and synthesis of these endogenous signaling mediators, Complexa’s technologies act to amplify the existing anti-inflammatory and metabolic signaling mechanisms that promote the resolution and repair of acute and chronic tissue injury and disease. Complexa’s lead programs are in Renal Injury, Pulmonary diseases and diseases of the Central Nervous System.

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 actual future events or results to differ materially from such statements. 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.

For further information please visit or contact the company at 412.727.8727.


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Mike Beyer, 773-463-4211