ReNeuron Group plc Positive long-term data in retinal clinical trial (8240D)
24 February 2020 - 6:00PM
UK Regulatory
TIDMRENE
RNS Number : 8240D
ReNeuron Group plc
24 February 2020
24 February 2020 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Positive long-term data in retinal clinical trial
Meaningful clinical effect observed in patients out to 12 months
post-treatment
Expansion of ongoing Phase 2a study includes plans to open a UK
clinical site
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce
positive long-term data from the ongoing Phase 1/2a clinical trial
of its hRPC stem cell therapy candidate in retinitis pigmentosa
(RP) and plans to expand the ongoing study. RP is a group of
hereditary diseases of the eye that lead to progressive loss of
sight and blindness.
In October 2019, positive interim efficacy data from patients
treated in the Phase 2a segment of the ongoing Phase 1/2 study were
announced by the Company and subsequently presented by Dr. Pravin
Dugel at the American Academy of Ophthalmology Meeting in San
Francisco. The data showed a group of subjects who had had a
successful surgical procedure with sustained clinically relevant
improvements in visual acuity compared with baseline, as measured
by the number of letters read on the ETDRS chart (the standardised
eye chart used to measure visual acuity in clinical trials).
Subsequent long-term efficacy data from the study continue to
show a meaningful clinical effect from the therapy at all time
points out to twelve months post-treatment. As previously reported,
the degree of efficacy observed varies between patients, with mean
results as set out in the table below:
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 letters + 11.1 letters
(n=8) (n=8)
-------------------- --------------------- ---------------------
2 +10.8 letters (n=8) + 1.6 letters + 9.2 letters (n=8)
(n=8)
-------------------- --------------------- ---------------------
3 +14.0 letters (n=8) + 5.1 letters + 8.9 letters (n=8)
(n=8)
-------------------- --------------------- ---------------------
6 +15.7 letters (n=6) + 6.5 letters + 9.2 letters (n=6)
(n=6)
-------------------- --------------------- ---------------------
9 +16.5 letters (n=4) + 6.0 letters + 10.5 letters
(n=4) (n=4)
-------------------- --------------------- ---------------------
12 +14.3 letters (n=3) + 7.0 letters + 7.3 letters (n=3)
(n=3)
-------------------- --------------------- ---------------------
* In patients with a successful surgical procedure
The equivalent data set announced by the Company in October 2019
is as follows:
Months post-treatment Mean change from Mean change from Difference in
baseline in visual baseline in visual mean change between
acuity in treated acuity in untreated treated eye and
eye* eye* untreated eye*
1 +14.5 letters +1.5 letters (n=6) +13.0 letters
(n=6) (n=6)
-------------------- --------------------- ---------------------
2 +13.0 letters +3.5 letters (n=6) +9.5 letters
(n=6) (n=6)
-------------------- --------------------- ---------------------
3 +17.8 letters +8.3 letters (n=6) +9.5 letters
(n=6) (n=6)
-------------------- --------------------- ---------------------
6 +28.7 letters +9.0 letters (n=3) +19.7 letters
(n=3) (n=3)
-------------------- --------------------- ---------------------
9 +12.0 letters -1.0 letters (n=1) +13.0 letters
(n=1) (n=1)
-------------------- --------------------- ---------------------
* In patients with a successful surgical procedure
The Company has submitted a protocol amendment to the US FDA to
expand the Phase 1/2a study to treat up to a further nine patients
in the Phase 2a segment of the study with a dose of two million
hRPC cells, which compares with the dose of one million cells used
in the study thus far. The amended clinical trial protocol also
allows for a greater range of pre-treatment baseline visual acuity
in patients and includes changes that enhance the ability to use
microperimetry testing to measure and detect changes in retinal
sensitivity in patients treated.
The Company and its clinical advisers believe that this protocol
amendment will enable the efficacy signal observed in the study
thus far to be both better delineated and magnified when
demonstrated in a larger and more closely defined group of RP
patients.
In addition, the Company has submitted an application to the
MHRA to open the ongoing trial to a highly experienced UK clinical
site, the Oxford Eye Hospital, with Professor Robert MacLaren, a
world-renowned leader in the treatment of retinal diseases, as
Principal Investigator.
The Company expects to present further data from the expanded
Phase 1/2a clinical trial during the course of 2020 and expects to
have sufficient data from the study to enable it to seek approval
in the first half of 2021 to commence a pivotal clinical study with
its hRPC cell therapy candidate in RP.
ReNeuron's clinical programme in RP has been granted Orphan Drug
Designation in both Europe and the US, as well as Fast Track
designation from the FDA in the US. Orphan Drug Designation
provides the potential for a significant period of market
exclusivity once the therapy is approved in those territories. Fast
Track designation provides eligibility for an accelerated approval
and priority review process by the FDA.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"We remain greatly encouraged by the data from the Phase 1/2a
clinical study of our hRPC cell therapy candidate in patients with
RP. The longer-term follow-up data are particularly noteworthy,
demonstrating that the therapy appears to maintain its beneficial
effects out to at least one year post-treatment."
ENDS
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 lead 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 would otherwise be unable
to reach their site of action. ReNeuron's shares are traded on the
London AIM market under the symbol RENE.L. For further information
visit www.reneuron.com .
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCKZGZZLFVGGZM
(END) Dow Jones Newswires
February 24, 2020 02:00 ET (07:00 GMT)
Reneuron (LSE:RENE)
Historical Stock Chart
From Mar 2024 to May 2024
Reneuron (LSE:RENE)
Historical Stock Chart
From May 2023 to May 2024
