12 Jun 2019

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STUART, FLORIDA June 12, 2019: Stuart Therapeutics, Inc. (STUART), an innovative pre-clinical ophthalmic therapeutic development company, today announces it has entered into a strategic partnership with Ora®, Inc. (“ORA”), the premier global ophthalmology contract research organization.  ORA is investing in its partnership with STUART by providing CMC program execution, IND preparation, and related strategic consulting services.  STUART expects to commence FDA approved Phase 2 clinical trial testing with Ora’s assistance in mid to late 2020 for its lead drug candidate, ST-100.

ST-100, based on STUART’s proprietary PolyColTM collagen mimetic peptide platform, to which it has exclusive worldwide rights, will initially be developed for treatment of Dry Eye Disease (“DED”).  ST-100’s unique mechanism of action is seen as a significant advance in the therapeutic approach to DED, with the potential to offer rapid symptom relief and healing to the estimated 30 million DED sufferers 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+%.

“We are thrilled to be a part of the ST-100 program.  Supporting our clients to bring life-altering products to market is in our DNA, and has been for over 40 years.  STUART’s ST-100 product profile, with its unique mechanism of action suggests that it is a fast acting and broadly applicable therapy that targets and repairs the damaged collagen present in Dry Eye patients,” said George Ousler, Vice President, Dry Eye at ORA.

In pre-clinical proof of concept in vivo testing, ST-100 demonstrated accelerated repair of the epithelial layer, through binding of ST-100 to damaged sub-epithelial collagen layers.  Complete healing of these tissues and the epithelial layer occurred within approximately 24 hours.  STUART, with ORA’s assistance, recently completed a successful pre-IND meeting in early April, obtaining clear FDA guidance regarding: ST-100’s eligibility to move directly to Phase 2 post IND; and its Phase 2 trial design, including proposed Phase 2 endpoints.

“Ora has exceeded our expectations as a development partner,” said Eric Schlumpf, President & Chief Executive Officer of STUART. “Their deep expertise in ophthalmic therapeutic development, including in particular for us ocular surface indications such as Dry Eye, has been invaluable as we’ve engaged with the FDA, and advanced our program.”

Dry eye continues to be the most common reason for patients in the US to seek treatment from ophthalmologists and optometrists,” said David A. Hollander, MD, MBA, Chief Medical Officer for ORA.  “Dry Eye is a complex multi-factoral disease that continues to represent a significant unmet medical need.  The number of dry eye subjects continues to grow globally and dry eye is being seen in increasingly younger patients. Physicians eagerly await new therapeutic options to address this complex, multifactorial disease.  ST100 has the potential to be one of those options.”

Robert Baratta MD, a practicing ophthalmologist, and STUART’s Chairman and Chief Medical Officer, says “Practitioners like me remain frustrated with the fact we currently have little to offer patients in the effective treatment of this increasingly common malady. We believe Polycol’s extremely rapid relief of symptoms will be well received by patients and their doctors alike.  Stuart Therapeutics is delighted to be focusing on delivering an effective remedy.”

About Stuart Therapeutics, Inc.
Stuart Therapeutics’ mission is to offer unique solutions for difficult-to-treat diseases of the eye. The company is focused on research and development of ophthalmic 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 47 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.

Ora®  is a registered trademark of Ora, Inc.

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