15 June 2016 • Noveome Initiates Phase 2 Clinical Trial of ST266 to Treat Patients with Periodontitis

— Company is committed to fully explore the potential of ST266 across several disease areas and multiple indications —

PITTSBURGH – June 15, 2016 – Noveome Biotherapeutics, Inc., a clinical-stage company focused on the biology of paracrine signaling, today announced the initiation of a phase 2 clinical trial of its novel secretome, ST266, to treat patients with moderate to severe periodontitis, a severe inflammatory condition that leads to damage of the soft tissue and destruction of the bone that supports the tooth. The company is the leading innovator in paracrine signaling for the clinical development of novel biotherapeutic products that work safely and effectively in complex biologic processes.

“ST266 provides essential ‘tools’ at critical stages of the healing process to restore homeostasis within the periodontal microenvironment,” said Kenneth J. Mandell, M.D., Ph.D., Chief Medical Officer of Noveome. “The biological attributes of ST266, including the capacity to modulate inflammation, accelerate impaired wound healing, prevent bone loss and support bone regrowth, suggest that ST266 has the potential to become an important new treatment for those suffering with periodontitis.”

The phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled study of ST266 to evaluate the safety, efficacy, and treatment regimen of topical ST266 in patients with moderate to severe periodontitis. The primary efficacy endpoint of this study is the change from baseline in pocket depth evaluated after 3 months of treatment. Subjects will be followed for 9 months for safety and secondary efficacy endpoints. For additional information on this clinical trial, please visit www.clinicaltrials.gov, Identifier NCT02761993.

“An essential goal for intervention in periodontitis is the return of tissue homeostasis,” said Thomas Van Dyke, D.D.S., Ph.D. of the Forsyth Institute and Harvard School of Dental Medicine. “Conventional interventions such as root planing offer a temporary benefit in removing bacterial etiologic agents, but such procedures incompletely address the unregulated inflammation that is responsible for tissue damage in periodontal diseases. Noveome’s ST266 represents a promising new approach to treating periodontitis.”

Noveome previously conducted a phase 1 clinical trial at the Forsyth Institute in patients with gingivitis (NCT02071199), which demonstrated preliminary safety of ST266 as a topical oral therapy and efficacy in reducing probing depth and modulating inflammatory biomarkers in gingival crevicular fluid.

“This clinical trial is a significant corporate milestone in Noveome’s efforts to develop a pipeline of breakthrough products built on our pioneering understanding of paracrine signaling,” said A. Clarke Atwell, Chief Executive Officer and President of Noveome. “The complexity of ST266 provides the opportunity to pursue treatments for numerous disorders across multiple disease areas.”

About Periodontitis

Recent data indicates that more than 47% of adults or 65 million people in the U.S. alone suffer from periodontitis. Risk factors include age, smoking, stress, poor nutrition and obesity. Gingivitis is the mildest form of periodontal disease. It is characterized by red, swollen, and bleeding gums. If left untreated, gingivitis can advance to periodontitis in which plaque forms below the gum line and bacteria within the plaque produce toxins that stimulate a chronic inflammatory response leading to destruction of gum tissue and breakdown of bone. As periodontitis progresses, gums separate from the teeth forming pockets, and as the pockets deepen more gum tissue and bone are destroyed. Eventually, affected teeth can become loose and may have to be removed. Untreated periodontitis is associated with increased risk of heart disease and diabetes.

About ST266

ST266 is a novel secretome – a rich, complex solution of molecules secreted from proprietary cells. Instead of a single drug and target, the ST266 secretome contains many biologically active molecules, present in physiological concentrations. This secretome is a source of biomolecules necessary at critical points in biologic processes that are available at sufficiently low levels to avoid negative effects. ST266 demonstrates the following unique attributes, which can be applied across a wide range of disease indications to improve patient outcomes: modulates inflammation, speeds impaired wound healing, promotes bone restoration, restores nerve function and promotes nerve repair, regenerates cells, and a demonstrated safety profile.

About Noveome

Noveome is a privately-held, clinical stage biotherapeutics company leveraging the science of paracrine signaling to develop safe and effective products that treat complex diseases. The company’s paracrine therapeutic approach has potential to be applied across a wide range of disease indications to improve patient outcomes. The company’s lead product, ST266, is currently in a phase 2 clinical trial. The company, based in Pittsburgh, Pennsylvania, was founded in 2000 by Lancet Capital and faculty members from the McGowan Institute for Regenerative Medicine and has raised $119 million funding to date. For more information on Noveome visit www.noveome.com.


Noveome Biotherapeutics, Inc.

A. Clarke Atwell
Chief Executive Officer & President

Maureen L. Suda
Suda Communications LLC