24 May 2018 • Study Advances Novel Treatment for Damaged Optic Nerve

Preclinical Data Suggests Use Beyond Conditions of the Eye

PITTSBURGH – May 24, 2018 – A newly published scientific study has demonstrated that damage to the optic nerve can be significantly reduced, with the potential for improved visual function, when treated with ST266, the lead product of Noveome Biotherapeutics, Inc.

The preclinical study involved animals with a crushed optic nerve, a condition humans can experience through head injury or eye disease.

Currently there are no existing treatments to lessen or reverse damage and vision loss resulting from optic nerve trauma, and no existing methods are able to restore the function of the optic nerve.

The research was conducted in collaboration with Kenneth S. Shindler, M.D., Ph.D., a professor of Ophthalmology in the Perelman School of Medicine at the University of Pennsylvania.

The findings were published this week in Investigative Ophthalmology and Visual Science in an article titled, “RGC Neuroprotection Following Optic Nerve Trauma Mediated by Intranasal Delivery of Amnion Cell Secretome.” http://iovs.arvojournals.org/article.aspx?articleid=2681860

“These results offer hope for this untreatable cause of permanent vision loss,” said Dr. Shindler. “Further testing and development of this novel therapy may provide an opportunity to reduce future vision loss and neurologic disability in a host of diseases that currently have little or no treatment options.”

Wider Implications

ST266 is a rich, complex solution of biologically active molecules secreted from Noveome’s proprietary cells. Instead of a single drug and target, ST266 targets numerous pathways involved in the regenerative repair of inflamed or damaged tissues.

In the study, Dr. Shindler administered ST266 non-invasively through the nasal passages such that the ST266 reached the olfactory nerve in the back of the nose. This method allows ST266 to be delivered directly to the optic nerve and brain, a different route than traditional intranasal delivery that requires absorption of drugs through nasal tissue into the bloodstream.

Dr. Shindler found that ST266 significantly reduced damage to the optic nerve, as measured by a standard vision test called optokinetic response (OKR). Furthermore, showing a trend toward improved visual function and more active nerve cells, ST266 increased survival of the retinal ganglion cells (RGCs) that transmit visual signals from the eye to the brain.

Noveome’s Chief Scientific Officer, Larry R. Brown, Sc.D., sees even greater possibilities for delivery of ST266 based on these results. “These promising results reinforce the multifaceted potential of targeted ST266 in multiple neurodegenerative conditions of the brain including traumatic brain injury, chronic traumatic encephalopathy, or diseases such as Alzheimer’s Disease, Parkinson’s Disease, amyotrophic lateral sclerosis and stroke,” said Dr. Brown.

The model used in this study is particularly useful for testing therapies for glaucoma, where increased eye pressure can damage the optic nerve, and for vision problems that afflict a majority of military service personnel who have been diagnosed with traumatic brain injury. Both glaucoma and traumatic optic nerve injury can lead to severe or even permanent vision loss.

Later this year, Noveome plans to begin a Phase 1 clinical human safety trial for targeted delivery of ST266 deep into the nasal passages, in collaboration with the Israeli medical device maker SipNose and through funding provided by the Commonwealth of Pennsylvania.

Editor’s Note: Shindler has served as a scientific advisory board member and consultant to Noveome and has received funds from Noveome for his consulting services. In addition, Noveome has provided unrestricted funds to Penn to support research in Shindler’s laboratory.

About ST266

ST266 is a novel secretome developed and manufactured by Noveome in its GMP manufacturing facility in Pittsburgh, Pennsylvania. In multiple preclinical studies, ST266 has demonstrated unique attributes of modulating inflammation, restoring nerve function, speeding impaired wound healing, and restoring cellular homeostasis, indicating that it can be applied across a wide range of disease indications to improve patient outcomes. Noveome has already treated 233 subjects with ST266 in eight clinical trials in various indications. It was found to be well-tolerated and there were no drug-related adverse events reported, attesting to its strong safety profile. Previous studies using an optic neuritis model were reported in Scientific Reports volume 7, Article number: 41768 (2017).

About Noveome

Noveome is a clinical stage company focused on breakthrough therapies for the regenerative repair of inflamed or damaged tissues. The company, formerly called Stemnion, Inc., is located in the heart of Pittsburgh’s riverfront Technology Center. The company received seed money from UPMC Enterprises, University of Pittsburgh and Carnegie Mellon University when it was founded in 2000. To date, Noveome has received $114 million in research funding, primarily from the U.S. Department of Defense as well as other state and county government agencies. Noveome is passionate about growing its business in Allegheny County and helping the region to become a world leader in biotechnology research and development. www.noveome.com.

###

CONTACT:

Noveome Biotherapeutics, Inc.
Gail Kempler, Ph.D., (412) 402-9914
Director, Investor Relations
gkempler@noveome.com

Media Inquiries:
Rich Creehan
(412) 341-1607
creehanmedia@gmail.com