New Company, Aerpio Therapeutics, Created to Advance Novel Tie-2 Activators and HIF-1a Stabilizers for Multiple Diseases

- Lead Tie-2 Program is in Clinical Development for Diabetic Eye Disease –

CINCINNATI--()--Aerpio Therapeutics today announced its debut as a stand-alone clinical-stage biotechnology company developing novel small molecule Tie-2 activators and HIF-1α stabilizers for multiple diseases. Aerpio was created in a spin-out transaction from Akebia Therapeutics and is seeking to raise a Series A financing round in 2012.

Aerpio’s lead program, AKB-9778, is a Tie-2 activator under development for diabetic macular edema (DME) and a Phase 2a study is expected to begin in Q2 of 2012. The second program includes Hypoxia-inducible Factor 1α (HIF-1α) stabilizers, with AKB-4924 in late preclinical development for inflammatory bowel disease.

“The formation of Aerpio allows us to focus and attract resources to the substantial opportunity we believe our lead programs represent,” stated Joseph Gardner, Ph.D., President and CEO of Aerpio and Akebia. “AKB-9778 could enable a transformation in the management of diabetic macular edema. As a first-in-class stabilizer of the Tie-2 receptor, AKB-9778 has the potential to achieve superior levels of vascular stabilization through systemic delivery, without the need for intravitreal injections to the eye. We hope to have results from the planned Phase 2 study of AKB-9778 by year end.”

The spin out of Aerpio is representative of a broader industry trend in venture-backed companies to fully leverage the potential inherent in multiple medically-significant programs. "This transaction provides investors the opportunity to capture both the near-term and long-term value of these promising programs,” stated Campbell Murray, Managing Director, Novartis Venture Funds.

More information on Aerpio is available at www.aerpio.com.

About Aerpio’s Tie-2 Program – AKB-9778

AKB-9778 works by inhibiting the Human Protein Tyrosine Phosphatase β (HPTPβ) enzyme which acts as a negative regulator of the Tie-2 receptor. By inhibiting this negative regulator, Tie-2 signaling is restored, overcoming the effects of the Ang2-induced vascular destabilization. Tie-2 activators have potential utility in a range of important clinical indications but Aerpio is currently focusing development of its lead candidate, AKB-9778, in diabetic macular edema, with a Phase 2a trial for that indication planned to start in Q2 2012.

About Aerpio’s HIF-1α Program – AKB-4924

AKB-4924 stabilizes HIF-1α by inhibiting HIFprolyl hydroxylases (PHD), particularly PHD-2. Pre-clinical studies have shown AKB-4924 stimulates innate immunity and thus promotes wound healing. In inflammatory bowel disease (IBD) models, AKB-4924 has been shown to protect and restore the epithelial barrier function in the lower GI tract. Aerpio expects to open an IND for AKB-4924 for the treatment of IBD in late 2012.

About Aerpio Therapeutics

Aerpio Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing innovative therapies for the treatment of diabetic eye disease and inflammatory bowel disease. Aerpio is a leader in the development of small molecule drugs based on Tie-2 activation and the stabilization of Hypoxia-inducible Factor 1α (HIF-1α). The company’s lead program, AKB-9778, is a first-in-class stabilizer of the Tie-2 pathway and is in clinical development for diabetic macular edema. AKB-4924, a HIF-1α stabilizer, is in late preclinical development for inflammatory bowel disease. More information is available at www.aerpio.com.

Contacts

Aerpio Therapeutics, Inc.
Ian Howes, 513-985-1923
Vice President and CFO
ihowes@aerpio.com
or
MacDougall Biomedical Communications
Jen Conrad, 781-235-3060
jconrad@macbiocom.com

Release Summary

Aerpio Therapeutics today announced its spin-out from Akebia Therapeutics, debuting as a stand-alone clinical-stage biotechnology company.

Contacts

Aerpio Therapeutics, Inc.
Ian Howes, 513-985-1923
Vice President and CFO
ihowes@aerpio.com
or
MacDougall Biomedical Communications
Jen Conrad, 781-235-3060
jconrad@macbiocom.com