TIDMALM
RNS Number : 5766Z
Allied Minds PLC
18 December 2017
SciFluor announces positive top-line results of phase 1/2 study
of SF0166 eye drops to treat wet age-related macular
degeneration
Demonstrated safety with no drug-related serious adverse
events
Improvements in vision along with significant decreases in
central retinal thickness and fluid levels reported
Preparation of Phase 2 trials underway
Boston, MA, 18 December 2017 - SciFluor Life Sciences, Inc.
(SciFluor), a subsidiary of Allied Minds, today announces positive
top-line results of a Phase 1/2 trial studying the treatment of
'wet' age-related macular degeneration (AMD) patients with SF0166,
the company's lead eye drop drug for back of the eye diseases. The
double masked Phase 1/2 study assessed the safety, tolerability and
preliminary efficacy of SF0166 in 42 evaluable subjects with
neovascular (wet) AMD who were randomized 1:1 to self-administer an
eye drop containing either a 2.5% or a 5% solution of SF0166
twice-a-day for 28 days.
The primary outcome measure of safety was clearly 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 5 patients; all events were mild or moderate in
severity, with one considered possibly drug-related.
SF0166 also demonstrated clinically significant biological
activity, as assessed by a panel of three leading retinal
physicians, in 9 of the 42 patients who completed the study
evidenced by decreases in central retinal thickness and/or
subretinal fluid by spectral domain optical coherence tomography.
The mean improvement in visual acuity during the treatment period
among the treatment naïve group was approximately 5 letters.
"SF0166 was very well-tolerated in this phase 1/2 study, and the
demonstration of biological activity seen in patients in this
heterogenous population of wet-AMD patients despite the short study
duration was encouraging for a topical treatment," said Jeffrey S.
Heier, MD, Ophthalmic Consultants of Boston. "I look forward to the
continued clinical advancement of SF0166."
"Combined with our previously reported data in diabetic macular
edema patients, we now have an impressive safety profile for SF0166
in over 80 patients coupled with distinct evidence of biological
activity for both indications. This implies that the drug is not
only well-tolerated but that it is reaching the back of the eye and
is active," said Omar Amirana, M.D., SciFluor's Chief Executive
Officer and Senior Vice President at Allied Minds. "These exciting
results highlight the prospect that wet-AMD and DME patients could
be treated with an eye drop that penetrates to the back of the eye.
If approved, an eye drop therapy could encourage earlier treatment
in the course of the disease which has the potential to improve
outcomes, while offering obvious patient benefits versus current
injectable alternatives."
Jill Smith, Chief Executive Officer of Allied Minds, commented
"These results for wet-AMD provide further validation of the
preclinical work undertaken at SciFluor and there is a clear case
to proceed to Phase 2 trials for both DME and wet-AMD. 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 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 42 evaluable wet-AMD patients who were randomized 1:1
to either a 2.5% or a 5% solution of SF0166 self-administered 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 8 sites in
the US (clinicaltrials.gov ID#: NCT02914639) and included
treatment-naïve patients as well as patients with prior anti-VEGF
treatment.
About SF0166
SciFluor is developing SF0166, a novel, 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 preclinical
assays and shown to reach the back of the eye and be effective in
validated in vivo models of macular disease. SF0166 has also been
studied in a separate multi-center, randomized, Phase 1/2 trial has
been in patients with Diabetic Macular Edema (DME)
(clinicaltrials.gov ID# NCT02914613).
About 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 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 sought promptly. These treatments require frequent
injections of biologic drugs into the back of the eye performed in
a doctor's office. Generally, the effectiveness of these treatments
decreases with time, therefore improved treatments are actively
being sought. A topically administered drug that is safe and
effective would be a major advance in patient care.
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
MSCGGGWCPUPMPUM
(END) Dow Jones Newswires
December 18, 2017 02:00 ET (07:00 GMT)
Allied Minds (LSE:ALM)
Historical Stock Chart
From Apr 2024 to May 2024
Allied Minds (LSE:ALM)
Historical Stock Chart
From May 2023 to May 2024