TIDMRENE
RNS Number : 2977R
ReNeuron Group plc
29 June 2020
29 June 2020 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Further positive data in retinal clinical trial
Further long-term data demonstrate continuing, clinically
meaningful efficacy at all time-points measured out to 18 months
post-treatment
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce
further positive long-term data from the ongoing Phase 2a clinical
trial of its hRPC stem cell therapy candidate in retinitis
pigmentosa (RP). RP is a group of hereditary diseases of the eye
that lead to progressive loss of sight and ultimately
blindness.
On 24 February 2020, positive interim efficacy data from
patients treated in the Phase 2a study were announced by the
Company. The data continued to show a meaningful clinical effect
from the therapy at all time-points out to twelve months
post-treatment, as measured by the number of letters read on the
ETDRS chart (the standardised eye chart used to measure visual
acuity in clinical trials).
Since those results were announced, further long-term data from
the study have been gathered from patients at six, nine, twelve and
now, for the first patient treated, eighteen months follow-up. The
Company is pleased to report that the latest data continue to
demonstrate the efficacy of the therapy, with a clinically
meaningful benefit being observed at all time-points. These results
are particularly encouraging as RP is characterised by inexorable
progression to blindness, with no therapy currently available for
the vast majority of patients.
The results announced on 24 February 2020 excluded two subjects
who experienced sight loss as a result of complications arising
from the surgical procedure. The Company is pleased to report that
one of these two patients has now recovered their vision and is
back to at least baseline at one year post treatment.
As previously reported, the degree of efficacy observed varies
between patients, with the latest mean results set out in the
tables below. The first table shows the latest data including the
above-mentioned patient who has recovered to at least the baseline
level of vision in the treated eye. The second table shows the
latest data excluding both of the patients who originally
experienced surgical complications, to provide a comparison against
the data previously announced on 24 February 2020.
Months post-treatment Mean change from Mean change from Difference in mean
baseline in visual baseline in visual change between
acuity in treated acuity in untreated treated eye and
eye* eye* untreated eye*
1 +7.9 letters (n=9) +0.2 (n=9) +7.7 (n=9)
-------------------- --------------------- -------------------
2 +8.0 letters (n=9) +1.2 (n=9) +6.8 (n=9)
-------------------- --------------------- -------------------
3 +10.8 letters (n=9) +4.4 (n=9) +6.4 (n=9)
-------------------- --------------------- -------------------
6 +9.6 letters (n=9) +3.4 (n=9) +6.2 (n=9)
-------------------- --------------------- -------------------
9 +7.1 letters (n=8) +1.2 (n=8) +5.9 (n=8)
-------------------- --------------------- -------------------
12 +11.9 letters (n=5) +4.3 (n=5) +7.6 (n=5)
-------------------- --------------------- -------------------
18 +17.0 letters (n=1) +1.0 (n=1) +16.0 (n=1)
-------------------- --------------------- -------------------
* Excluding one patient who experienced surgical
complications
Months post-treatment Mean change from Mean change from Difference in mean
baseline in visual baseline in visual change between
acuity in treated acuity in untreated treated eye and
eye* eye* untreated eye*
1 +11.4 letters (n=8) +0.3 (n=8) +11.1 (n=8)
--------------------- --------------------- -------------------
2 +10.8 letters (n=8) +1.6 (n=8) +9.2 (n=8)
--------------------- --------------------- -------------------
3 +14.0 letters (n=8) +5.1 (n=8) +8.9 (n=8)
--------------------- --------------------- -------------------
6 +12.3 letters (n=8) +3.4 (n=8) +8.9 (n=8)
--------------------- --------------------- -------------------
9 +11.8 letters (n=7) +1.2 (n=7) +10.6 (n=7)
--------------------- --------------------- -------------------
12 +13.4 letters (n=4) +4.6 (n=4) +8.8 (n=4)
--------------------- --------------------- -------------------
18 +17.0 letters (n=1) +1.0 (n=1) +16.0 (n=1)
--------------------- --------------------- -------------------
* Excluding both patients who originally experienced surgical
complications
The equivalent data set announced by the Company on 24 February
2020 is as follows:
Months post-treatment Mean change from Mean change from Difference in mean
baseline in visual baseline in visual change between
acuity in treated acuity in untreated treated eye and
eye* eye* untreated eye*
1 +11.4 letters (n=8) +0.3 (n=8) +11.1 (n=8)
-------------------- --------------------- -------------------
2 +10.8 letters (n=8) +1.6 (n=8) +9.2 (n=8)
-------------------- --------------------- -------------------
3 +14.0 letters (n=8) +5.1 (n=8) +8.9 (n=8)
-------------------- --------------------- -------------------
6 +15.7 letters (n=6) +6.5 (n=6) +9.2 (n=6)
-------------------- --------------------- -------------------
9 +16.5 letters (n=4) +6.0 (n=4) +10.5 (n=4)
-------------------- --------------------- -------------------
12 +14.3 letters (n=3) +7.0 (n=3) +7.3 (n=3)
-------------------- --------------------- -------------------
* Excluding both patients who originally experienced surgical
complications
On 17 June 2020, the Company announced that it had received
regulatory approval from both the FDA and MHRA to expand the
ongoing Phase 2a clinical study to treat patients with RP at a
higher dose level. These approvals will enable the treatment of up
to a further nine patients in the Phase 2a extension segment of the
study (beyond the ten Phase 2a patients already treated). The
Company expects to commence treating patients shortly in both the
US and the UK under the revised approved study protocol, subject to
a continued easing of COVID-19 related restrictions at the relevant
clinical sites.
On this basis, and as announced on 17 June, the Company expects
to present further data from the expanded Phase 2a clinical trial
during the next twelve months and expects to have sufficient data
from the study to enable it to seek approval in the second half of
2021 to commence a single pivotal clinical study with its hRPC cell
therapy candidate in RP.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"The latest longer-term follow-up data from our Phase 2a study
of our hRPC cell therapy candidate in patients with RP continue to
demonstrate a meaningful clinical benefit at all time-points,
including in the first patient who has reached 18 months follow-up.
The persistence of the observed clinical benefit is particularly
encouraging . We look forward to announcing further data from the
study in due course, as a prelude to taking our hRPC cell therapy
into a pivotal, randomised study."
S
Contacts:
ReNeuron +44 (0) 20 3819 8400
Olav Hellebø, Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan (UK Media/Investor Relations) +44 (0) 20 7466 5000
Mark Court, Tilly Abraham
Argot Partners (US Media/Investor Relations)
Claudia Styslinger, David Rosen +1 212 600 1902
Stifel Nicolaus Europe Limited (NOMAD and
Joint Broker)
Jonathan Senior, Stewart Wallace, Ben Maddison +44 (0) 20 7710 7600
N+1 Singer (Joint Broker)
Aubrey Powell, James Moat, Tom Salvesen +44 (0) 20 7496 3000
About ReNeuron
ReNeuron is a global leader in cell-based therapeutics,
harnessing its unique stem cell technologies to develop 'off the
shelf' stem cell treatments, without the need for immunosuppressive
drugs. The Company's clinical-stage candidates are in development
for the blindness-causing disease, retinitis pigmentosa, and for
disability as a result of stroke.
ReNeuron is also advancing its proprietary exosome technology
platform as a potential delivery system for drugs that treat
diseases of the brain. The Company also has the ability through its
conditionally immortalised induced pluripotent stem cell (iPSC)
platform to make any tissue cells of choice; in-house programmes
are focused on treatments for blood cancers and diabetes.
ReNeuron's shares are traded on the London AIM market under the
symbol RENE.L. For further information visit www.reneuron.com .
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END
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