CAMBRIDGE, Mass.--(BUSINESS WIRE)--SciFluor Life Sciences, Inc., a clinical stage biopharmaceutical company that strives to create innovative best-in-class therapeutics for patients in multiple disease categories including ophthalmologic and neurologic disease, announced today that the first patients have been dosed in both Phase I/II trials of SF0166 Topical Ophthalmic Solution. This represents an important step forward in the clinical investigation of SF0166 Topical Ophthalmic Solution as a potential new treatment for diabetic macular edema (DME) and age-related macular degeneration (wet-AMD), which are disease states that represent a combined estimated $8 billion current market value.
“SciFluor is on the path towards executing its mission of advancing drug candidates in billion dollar markets which may be capable of significantly improving patients’ lives. This terrific achievement marks yet another clinical stage advance in the Allied Minds life sciences portfolio.”
Clinical Study SF0166-C-001 is designed to be a multi-center, randomized Phase I/II trial being conducted in the United States to evaluate the safety and preliminary efficacy of SF0166 for the treatment for patients with DME. A separate multi-center, randomized, Phase I/II trial of SF0166 has been initiated in patients with wet-AMD. Each trial has 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 and visual acuity. Details of these trials can be found at www.ClinicalTrials.gov.
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 DME or wet-AMD.
“We are pleased to have initiated clinical studies of SF0166 for the treatment of DME and wet-AMD and look forward to generating the clinical data required to advance this potential new therapy,” said D. Scott Edwards, Ph.D., Vice President and General Manager at SciFluor. “The two on-going Phase I/II studies will provide initial assessments of the safety, tolerability and preliminary efficacy of SF0166 in patients to guide further clinical development.”
Omar Amirana, MD, SciFluor’s Chief Executive Officer and Senior Vice President at Allied Minds, said, “SciFluor is on the path towards executing its mission of advancing drug candidates in billion dollar markets which may be capable of significantly improving patients’ lives. This terrific achievement marks yet another clinical stage advance in the Allied Minds life sciences portfolio.”
SciFluor is a subsidiary of Allied Minds (LSE: ALM), a diversified holding company focused on venture creation within the life science and technology sectors.
About SF0166
SciFluor is developing SF0166, a potent and
selective small molecule inhibitor of integrin avß3 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. The
non-fluorinated compound on which it is based does not distribute
appreciably to the back of the eye after topical administration.
About DME
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 traditionally
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, improved
treatment options could benefit patients.
About wet-AMD
Age-related Macular Degeneration (AMD) is the
most common cause of severe vision loss in older Americans. 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 a 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 frequent intravitreal injection. Generally, the effectiveness of
these treatments decreases with time, therefore improved treatments are
actively being sought after. A topically administered drug that is safe
and effective could potentially be a major advance in the treatment of
retinal disorders.
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 (LSE: ALM) 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 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.
Allied Minds Forward-Looking Statement
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risk and uncertainties described in the risk factors included in the company’s regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law, regulatory requirement, the Prospectus Rules, the Listing Rules and the Disclosure and Transparency Rules, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact:
fama PR for SciFluor
Ted Weismann,
617-986-5009
alliedminds@famapr.com
