CAMBRIDGE, Mass.--(BUSINESS WIRE)--SciFluor Life Sciences, Inc., a clinical stage biopharmaceutical company developing a portfolio of therapeutic drugs capitalizing on the transformational power of fluorine, today announced that the Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) is now in effect for SF0166 Topical Ophthalmic Solution (SF0166). This enables the company to initiate clinical testing of SF0166 in both wet Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) patients, two retinal diseases that are among the leading causes of blindness globally.
AMD and DME patients are typically treated by regular injections to the back of the eye. SF0166 will be administered in the form of eye drops, and is intended to replace these monthly injections. If successful, this would represent a major advance in the treatment of these diseases, which today represents in excess of $8 billion in annual revenue.
Ben Askew, Ph.D., Vice President of Research at SciFluor and the lead on the SF0166 therapeutic program, said, “The development of SF0166 provides validation of our fluorine-centered approach to bringing new transformational therapies to patients with serious illnesses. SF0166 demonstrates how appropriately placed fluorine modifications can improve the physical properties of a molecule, and address the challenge of getting enough drug to the back of the eye when administered using much more convenient eye drops.”
Clinical Study SF0166-C-001 is designed to be a multi-center, randomized Phase I/II trial in the United States to evaluate the safety and preliminary efficacy of SF0166 for the treatment of patients with DME. A separate multi-center, randomized, Phase I/II trial of SF0166 is planned for patients with neovascular (or ‘wet’) AMD. The trials each are intended to have two dose groups of up to 20 patients with an aim to collect safety and tolerability data as well as to record changes in retinal thickness.
In preclinical models, SF0166 has been shown to distribute to the back of the eye in therapeutically-effective amounts. The development of topically administered treatments for retinal diseases has long been considered an enormous challenge by the scientific and medical communities. This is largely because clinically relevant amounts of any given drug need to reach the retina and be retained for an appropriate period of time to exert a therapeutic effect. To date, no topically administered drug has been approved for the treatment of either wet AMD or DME.
Omar Amirana, MD, SciFluor’s Chief Executive Officer and Senior Vice President at Allied Minds, said, “This achievement marks the beginning of a new era for SciFluor as a clinical development stage company. We are pleased to have advanced SF0166 rapidly through pre-clinical development culminating in a successful IND filing and look forward to generating the clinical data required to advance this potential new therapy.”
SciFluor is a subsidiary of Allied Minds (LSE: ALM), a diversified holding company focused on venture creation within the life science and technology sectors.
SciFluor is developing SF0166, a potent and selective small molecule inhibitor of integrin αvβ3 with an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical administration to the eye. It has been tested in an extensive set of pre-clinical assays and shown to be effective in a validated in vivo model of wet AMD.
Diabetic Macular Edema (DME) is the swelling of the retina in diabetics due to the leakage of fluid from blood vessels within the macula. The macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving. As macular edema develops, blurring occurs in the middle or just to the side of the central visual field. Visual loss from diabetic macular edema can progress over a period of months and make it impossible to focus clearly. Treatment options for patients with DME include anti-VEGF drugs, corticosteroid drugs, and laser surgery. The anti-VEGF drugs are administered by frequent intravitreal injections into the back of the eye performed in a doctor’s office. Corticosteroid use increases the risk of cataracts and glaucoma. Therefore, there remains the need for improved treatment options.
Age-related Macular Degeneration (AMD) is the most common cause of severe vision loss in older patients. It affects central vision and may interfere with daily tasks such as reading and driving. Macular degeneration affects the retina in two forms – dry and wet AMD, also called neovascular AMD. Wet AMD is frequently accompanied by relatively sudden loss of vision. This is caused by the growth of abnormal blood vessels underneath the retina that leak fluid or blood. Recent advances in the treatment of wet AMD can now prevent further loss of vision, or even restore vision in some cases, if treatment is given promptly. Primary treatment is the use of anti-VEGF drugs administered by repeated intravitreal injection. Generally, the effectiveness of these treatments decreases with time, which highlights that improved treatments could benefit such patients.
About SciFluor Life Sciences LLC
SciFluor Life Sciences is a drug discovery company developing a best-in-class portfolio of partnership-ready therapeutic drugs strategically capitalizing on the transformational power of fluorine. The company creates new chemical entities (NCEs) directed towards precedented biological targets. SciFluor strategically incorporates fluorine or fluorine-containing groups to design drugs with improved pharmacological profiles that provide important benefits over existing therapies such as improved safety, efficacy, tissue penetration, more convenient dosing and better patient compliance. This capital-efficient and de-risked drug discovery approach has resulted in the generation of a proprietary pipeline of novel and differentiated small molecule drugs across a range of therapeutic categories and disease areas including retinal disease, CNS disorders, and inflammatory disease and pain.
About Allied Minds
Allied Minds is a diversified holding company focused on venture creation within the life science and technology sectors. With unparalleled access to hundreds of university and federal labs across the U.S., Allied Minds forms, funds, and operates a portfolio of companies to generate long-term value for its investors and stakeholders. Based in Boston, with a nationwide presence in Los Angeles and New York, Allied Minds supports its businesses with capital, central management, and shared services. For more information, please visit www.alliedminds.com.
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