UncategorizedStuart Therapeutics, Inc. Announces Relationship with Ora, Inc. for IND Preparation, Regulatory Advisory, and Clinical Trial Services for ST-100

February 25, 2019

Stuart Therapeutics, Inc. Announces Relationship with Ora, Inc. for IND Preparation, Regulatory Advisory, and Clinical Trial Services for ST-100
STUART, FLORIDA February 25, 2019: Stuart Therapeutics, Inc. (STUART), an innovative pre-clinical therapeutic development company, today announced that it has retained the services of Ora®, Inc., the premier ophthalmology Contract Research Organization (“CRO”) globally, to provide various product development, IND preparation, regulatory advisory and clinical trial services for STUART’s first drug candidate, ST-100.

ST-100 is based on the proprietary PolyColTM collagen mimetic peptide platform, to which STUART has exclusive worldwide rights, and will initially be developed for treatment of dry eye disease (“DED”). ST-100’s unique mechanism of action, healing damaged collagen in the anterior segment of the eye, is seen as a significant advance in the therapeutic approach to DED, with the potential to offer rapid relief to the estimated 30 million sufferers of this condition in the United States alone. The worldwide market for DED treatment is estimated to be in excess of $7 billion and growing at a CAGR of 7+%.

In pre-clinical proof of concept testing, ST-100 has demonstrated accelerated repair of the epithelial layer, through binding of ST-100 to exposed sub-epithelial collagen layers. Complete repair of these tissues and the epithelial layer occurred within approximately 24 hours. ST-100 is expected to be broadly applicable to the patient population and should have therapeutic applications in patients regardless of the underlying cause of their DED. STUART and ORA will be meeting with the U.S Food and Drug Administration (FDA) for a pre-IND meeting in early April 2019 to confirm IND submittal requirements and Phase II clinical trial design for ST-100.

“Ora was the first partner that we sought out as we began to pursue ST-100 applications in ophthalmology,” said Eric Schlumpf, President & Chief Executive Officer of STUART. “They are the leader in ophthalmology and selecting them as our provider was the right strategic decision for our company. Dry eye is a difficult indication for physicians and patients due to the long and uncertain treatment cycle associated with current anti-inflammatory approaches to treating the disease.”

“Despite several product approvals and a number of drugs in the development pipeline, Dry Eye Disease remains an ophthalmic disease with significant unmet medical needs. Prescription renewal rates for anti-inflammatory therapies are low, and physicians and patients have limited therapeutic options that deliver rapid relief,” said David A. Hollander, MD, MBA, Chief Medical Officer of Ora. “DED is one of the leading reasons for patient visits to eye care specialists. Novel therapies that treat the signs and symptoms of DED will be welcomed by both dry eye sufferers and physicians.”

“We see ST-100 as an important addition to the arsenal for physicians, who will be able to offer their patients rapid relief and effective repair of ocular surface damage associated with DED” said Robert Baratta, MD, Chairman and Chief Medical Officer of STUART. “We look forward to working with the Ora team in the development and clinical testing of ST-100 for treating DED, and improving patients’ vision and satisfaction with their treatment.”

“We are pleased to support STUART on the development of ST-100 for the treatment of DED. Better understanding DED and evaluating novel therapies to treat this prevalent disease has been at the heart of what we do for over twenty years. ST-100 has the potential to be a broad acting, first line therapy for DED which is exciting for the patients who are counting on us to bring additional therapeutic options to market.” said George Ousler, Ora’s Vice President of Dry Eye.

Stuart Therapeutics’ mission is to offer unique solutions for difficult-to-treat diseases of the eye. STUART is focused on the research, development and production of ophthalmic and other therapeutic products based on the company’s proprietary PolyCol Collagen Mimetic Peptide platform. The company is developing PolyCol first as a therapeutic for Dry Eye Disease in its initial drug candidate, ST-100, and has several other ophthalmic indications in discovery and pre-clinical stage.

For more information, please visit www.StuartTherapeutics.com.

About Ora®, Inc.
Ora is the world’s leading full-service ophthalmic product development firm with offices in the United States, the United Kingdom, Australia and Japan. Over the past 40 years, we have proudly helped our clients earn 46 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com.