TIDMALM
RNS Number : 0150S
Allied Minds PLC
28 September 2017
SciFluor announces positive top-line results of phase 1/2 study
of SF0166 topical (eye drop) ophthalmic solution in Diabetic
Macular Edema patients
Demonstrated safety with no drug-related serious adverse
events
Greater than 50% of treated patients experienced a decrease in
retinal thickness
Preparation for phase 2 trials underway
Boston, MA (28 September 2017) - SciFluor Life Sciences, Inc.
(SciFluor), a subsidiary of Allied Minds, today announced positive
top-line results of a Phase 1/2 study of SF0166, the company's lead
drug in development for the topical (eye drop) treatment of
patients with diabetic macular edema (DME).
The Phase 1/2 study assessed the safety and preliminary efficacy
of SF0166 in 40 evaluable patients with DME who were randomized to
one of two dose strengths (2.5% and 5.0% solutions)
self-administered by patients as an eye drop twice-a-day for 28
days, with a 28 day follow-up period. Results from a trial of
SF0166 in patients with Age-related Macular Degeneration (AMD)
remain pending.
The primary outcome measure of safety was achieved with no
drug-related serious adverse events observed in the study
throughout the 28-day course of treatment as well as during the
28-day follow-up period. Ocular adverse events were recorded in the
treated eyes of 6 patients. All events were mild in severity, with
one considered possibly drug-related.
SF0166 demonstrated biological activity in both patient groups
(2.5% and 5% solutions), with 53% of the evaluable patients
demonstrating a reduction in retinal thickness (RT), and
improvements in visual acuity were also recorded. Durability of RT
response to the 28-day course of therapy was observed during the
month after discontinuing treatment.
There were no significant decreases in visual acuity in study
eyes during treatment or follow-up and no patient required rescue
treatment with an anti-VEGF injection during the treatment phase.
Regular anti-VEGF injections to the eye represent current standard
of care for DME (and AMD).
Based on these outcomes, SciFluor has decided to proceed to
phase 2 trials for SF0166.
"The safety and biological activity, clearly demonstrated in
this first-in-patient study, supports continued clinical
development of SF0166," said David Boyer, MD, Retina-Vitreous
Associates Medical Group of Los Angeles. "DME is a devastating
condition that often results in vision loss. A safe and effective
eye drop treatment for patients living with DME would be a major
advance in the fight against this debilitating disease. A potential
eye-drop treatment for DME may not only increase compliance, but
also allow the opportunity to prevent vision loss by treating
earlier in the disease pathway."
"We believe SF0166 represents an important breakthrough in the
treatment of retinal disease given its unique mode of action and
its administration as an eye drop" said Omar Amirana, MD,
SciFluor's Chief Executive Officer and Senior Vice President at
Allied Minds. "We look forward to further advancing SF0166. We
would like to thank the patients who participated in this study and
the investigators and study staff who share our commitment to
advancing the treatment of DME."
Jill Smith, CEO of Allied Minds, commented "These results
provide strong validation of the pre-clinical work undertaken at
SciFluor with regard to SF0166, and a clear case for proceeding to
phase 2 trials, for which SciFluor is now preparing. Results for
wet-AMD phase 1/2 trials are due later this year. SF0166 is
targeting a very large and growing market, with existing injectable
drugs for DME and wet-AMD generating combined annual revenues
exceeding $8 billion."
ENDS
For more information, please contact:
Allied Minds plc +44 7771 872 922
Neil Pizey, Head of Corporate
Development
FTI Consulting +44 20 3727 1000
Ben Atwell / Brett Pollard
About the Phase 1/2 Clinical Trial
The Phase 1/2 study assessed the safety and preliminary efficacy
of SF0166 in 40 evaluable patients with DME who were randomized to
one of two dose strengths (2.5% and 5.0% solutions)
self-administered by patients as an eye drop twice-a-day for 28
days. The patients were further assessed over an additional 28-day
follow-up period off SF0166. The study was conducted at 6 sites in
the US (clinicaltrials.gov ID#: NCT02914613) and included
treatment-naïve patients as well as patients with prior anti-VEGF
treatment.
About SF0166
SF0166 is a patented, potent and selective small molecule
inhibitor of integrin <ALPHA>v<BETA>3 with an optimum
balance of physiochemical properties to allow it to distribute to
the retina in high concentrations after topical (eye drop)
administration to the eye. It has been tested in an extensive set
of pre-clinical assays and shown to reach the back of the eye and
be effective in validated in vivo models of macular disease. SF0166
is also being studied in a separate multi-center, randomized, Phase
1/2 trial has been in patients with neovascular (wet) age-related
macular degeneration (AMD) (clinicaltrials.gov ID#
NCT02914639).
About DME
Diabetic Macular Edema (DME) is the swelling of the retina in
diabetic patients due to the leakage of fluid from blood vessels
within the macula. The macula is important for the sharp,
straight-ahead vision. As macular edema develops, blurring occurs
in the middle or just to the side of the central visual field.
Visual loss from DME 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. While the biology
and pathology of DME have been generally understood, safe and
effective topical therapy has traditionally remained elusive.
According to the U.S. Centers for Disease Control, approximately 30
million Americans are living with diabetes and over 1 million
diabetic patients experience DME.
About SciFluor Life Sciences, Inc.
SciFluor creates proprietary best-in-class drugs based on
well-understood pathways in areas of significant medical need such
as ophthalmology, neuroscience and fibrotic diseases. Our lead
clinical drug candidate, SF0166, is an eye drop therapeutic for
treating back-of-the-eye diseases www.scifluor.com
About Allied Minds
Based in Boston, Allied Minds plc is an IP commercialisation
company focused on technology and life sciences. With extensive
access to U.S. federal government laboratories and universities, as
well as partnerships with leading U.S. corporations, Allied Minds
forms, funds, and operates a portfolio of companies with the
objective of delivering successful liquidity events that will
generate attractive long-term returns for its investors and
stakeholders. Allied Minds supports its businesses with capital,
resources, and expertise. 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCEASNXASEXEFF
(END) Dow Jones Newswires
September 28, 2017 02:00 ET (06:00 GMT)
Allied Minds (LSE:ALM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Allied Minds (LSE:ALM)
Historical Stock Chart
From Sep 2023 to Sep 2024