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Regulatory News:
Medincell (Paris:MEDCL) today announced that the Phase 3 trial
for F14 (mdc-CWM) being conducted by Arthritis Innovation
Corporation (AIC) did not meet its primary endpoint of
time-weighted AUC1 of pain intensity over 14 days when comparing
treatment with multimodal analgesia (MMA) alone to MMA concurrent
with a single dose of F14 administered in the knee at the time of
Total Knee Replacement (TKR). The MMA control analgesia that every
patient received was defined by the protocol as standard of care
periarticular infiltration with bupivacaine, oral acetaminophen and
opioid rescue medication.
A numerical improvement favoring F14 was observed for the
primary endpoint. Secondary endpoints of time-weighted AUC of pain
over 3 and 7 days also demonstrated numerical improvement favoring
F14. The safety profile for F14 was consistent with the prior Phase
2 study, and no new safety signals were identified, and no SAEs2
were reported as related to F14 treatment.
Based on Medincell’s BEPO® technology, F14 represents a novel
sustained-release, non-steroidal anti-inflammatory drug (NSAID) for
intra-articular, targeted delivery. Thus, this study also
investigated multiple outcomes related to inflammation (and not
simply pain) following TKR. Substantial improvement was observed
for F14-treated patients for the key secondary endpoint of knee
range of motion (ROM) at 6 weeks, as well as at 3 months
(p<0.005 and p<0.0005 respectively; unadjusted for
multiplicity). Treated-knee effusion (i.e., swelling) showed highly
improved outcomes for the F14-treated patients compared to MMA at 6
weeks and 3 months (p<0.005 and p<0.05 respectively,
unadjusted for multiplicity). The widely used clinical-performance
based measure of lower extremity function, the Timed-Up-and-Go
(TUG) test was also improved for the F14 group at 6 weeks.
Notably, far greater improvements were observed for the
endpoints of time-weighted AUC of pain, ROM, effusion, and TUG in a
sub-group of patients representing over 70% of the trial population
(108/151) who had not previously undergone TKR in their
contralateral (non-study) knee. This subset analysis was
pre-specified in the protocol, but not alpha-controlled for formal
statistical testing. AIC intends to discuss the results from this
trial with regulators and explore alternative approval pathways for
F14 in this sub-group of patients.
Dr. Wayne Marshall, CEO of Arthritis Innovation Corporation and
a practicing orthopedic surgeon commented: “Local inflammation is a
serious adverse result of TKR, in addition to pain. So, although we
did not meet our primary pain endpoint, the totality of our data
which includes positive outcomes for multiple inflammatory and
functional measures, gives us continued confidence that F14 is a
critical adjunctive component to current standard of care MMA. The
identification of a large sub-group of TKR patients where the
impact of F14 is more clearly measured will likely be the focus of
our future clinical development.”
Dr. Richard Malamut, CMO of Medincell, added: “AIC has collected
encouraging data through this study, confirming that F14 can
significantly enhance recovery and reduce pain for a substantial
portion of patients undergoing TKR. This paves the way for
regulatory authority interactions to formulate a pathway for
approval. It should not have significant impact on our timeline
assumptions.”
1 Time-weighted Area Under the Curve (AUC) of pain is a
statistical measure used in clinical trials and pain management
studies to quantify the overall experience of pain over a specified
period. It integrates both the intensity of pain and the duration
for which that pain is experienced. 2 Severe Adverse Events
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical
licensing company developing long-acting injectable drugs in many
therapeutic areas. Our innovative treatments aim to guarantee
compliance with medical prescriptions, to improve the effectiveness
and accessibility of medicines, and to reduce their environmental
footprint. They combine active pharmaceutical ingredients with our
proprietary BEPO® technology which controls the delivery of a drug
at a therapeutic level for several days, weeks or months from the
subcutaneous or local injection of a simple deposit of a few
millimeters, entirely bioresorbable. The first treatment based on
BEPO® technology, intended for the treatment of schizophrenia, was
approved by the FDA in April 2023, and is now distributed in the
United States by Teva under the name UZEDY® (BEPO® technology is
licensed to Teva under the name SteadyTeq™). We collaborate with
leading pharmaceutical companies and foundations to improve global
health through new treatment options. Based in Montpellier,
Medincell currently employs more than 140 people representing more
than 25 different nationalities.
UZEDY® and SteadyTeq™ are trademarks of Teva Pharmaceuticals
www.medincell.com
This press release contains forward-looking statements,
including statements regarding Company’s expectations for (i) the
timing, progress and outcome of its clinical trials; (ii) the
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registered with the AMF on September 4, 2018, under number I.
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version on businesswire.com: https://www.businesswire.com/news/home/20240514147843/en/
David Heuzé Head of Corporate and Financial
Communications, and ESG david.heuze@medincell.com / +33 (0)6 83 25
21 86
Grace Kim Head of US Financial Strategy & IR
grace.kim@medincell.com / +1 (646) 991-4023
Nicolas Mérigeau/ Arthur Rouillé Media Relations
medincell@newcap.eu / +33 (0)1 44 71 94 94
Louis-Victor Delouvrier/Alban Dufumier Investor Relations
France medincell@newcap.eu / +33 (0)1 44 71 94 94
Medincell (EU:MEDCL)
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부터 4월(4) 2024 으로 5월(5) 2024
Medincell (EU:MEDCL)
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부터 5월(5) 2023 으로 5월(5) 2024