OPM Announces Positive Interim Results of Its Phase 1 Study Evaluating OPM-101 in Healthy Volunteers
02 Outubro 2023 - 1:00PM
Business Wire
- Completion of the single-dose administration (SDA) part of
the Phase 1 healthy volunteers study of OPM-101 and transition to
the multiple-dose escalation administration (MDA)
- A new mechanism of action normalizing TNF-alpha secretion
and targeting chronic inflammatory bowel disease (IBD)
- Excellent tolerability with no adverse events observed and
excellent safety range
- Significant target engagement over 24 hours, even at
moderate doses
- Favorable pharmacokinetic profile with once-daily oral
administration
- ANSM approval to start the multiple-dose administration
(MDA) part in Q4 2023
Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63;
Mnemonic: ALOPM) (Paris:ALOPM), a biopharmaceutical company
specializing in precision medicine for the treatment of resistant
and metastatic cancer, announces positive interim results at the
end of the first part of the Phase 1 single-ascending-dose oral
administration (SAD) study of its drug candidate OPM-101 in healthy
volunteers.
This first part of the Phase 1 trial was completed in 7 months.
72 healthy volunteers were randomized and OPM-101 was evaluated
against placebo using single oral administration at escalating
doses (SDA). This study demonstrated that OPM-101 had a significant
safety range, as doses tested varied from 5 to 1000 mg, and the
maximum tolerated dose was not reached.
Moreover OPM-101 demonstrated significant target engagement over
a 24-hour period, starting with low doses. At the end of the SAD,
OPM-101 demonstrated excellent tolerability in all cohorts. After a
single-dose oral administration of OPM-101 (at doses from 5 to 1000
mg), target engagement was observed at low doses as early as 1 h
after administration and maintained at a very significant level
over 24 h.
No serious or severe adverse events or dose-limiting toxicities
leading to study discontinuation were observed during the SAD part
of the study. The few adverse events possibly related to the
product were mainly minor, allowing repeated oral administration to
be envisaged with confidence.
OPM capitalized on the analysis of OPM-101 data obtained during
the SAD to optimize preparation of the second part of the study,
scheduled to start in Q4 2023, following ANSM approval:
- OPM-101 is rapidly absorbed orally, with an estimated half-life
elimination of 12 to 15 hours, enabling once-daily administration
with target engagement above 80%.
- Taking a fat-rich breakfast increased peak concentrations
(Cmax) and total exposure (AUC0-t) to the product. Administering
OPM-101 after breakfast therefore offers the possibility of
administrating lower doses to achieve equivalent levels of target
inhibition.
- A dedicated cohort was also used to assess the gender effect,
in preparation for the second part of the study, which will focus
on repeated administration for 14 days. At the end of each of the
seven dose-escalation cohorts, a data review committee agreed to
proceed to the next cohort with a higher dose.
Jan Hoflack, Chief Scientific Officer of OPM, said: «
OPM-101 was very well tolerated and demonstrated significant target
engagement over a 24-hour period, even at low doses. These
arguments are in favor of a significant therapeutic range. The Data
Review Committee (DRC) reviewed and analyzed all the data obtained
during the SDA part of the study and recommended the start of the
MDA (repeated administration) part of the study. In this part of
the study, OPM-101 will be administered twice a day at doses
designed to maintain target engagement above 80%. The MDA part is
scheduled to start in early Q4-2023. The completion of this Phase 1
SDA - 9 cohorts in just 7 months highlights the quality of our
OPM-101 product and of our preclinical and clinical teams. »
Philippe GENNE, President and Chief Executive Officer of
Oncodesign Precision Medicine, added: « We are very pleased
with the progress of this clinical trial at this stage. OPM-101 is
a molecule with an ideal pharmacological profile, a perfect drug
candidate that will enable us to fully test the therapeutic
potential of RIPK2 kinase inhibition in chronic inflammatory bowel
diseases with patients. These results reinforce our lead over our
main competitors identified today and are very impressive to the
world's leading key opinion leaders with whom we are working to
build the Phase 2 clinical trial. »
About OPM-101
OPM-101 is a macrocyclic molecule from OPM's proprietary
Nanocyclix® platform. It is a highly potent Type 1 inhibitor
(inhibitor in the active kinase cavity), selective of other kinases
and orally bioavailable. In pharmacology, OPM-101 has demonstrated
good efficacy in several preclinical models of colitis. Its safety
profile, characterized in preclinical studies, meets a quality
standard recognized by the pharmaceutical industry, and is
compatible with chronic administration to treat pathologies such as
IBD, one of the world's largest pharmaceutical markets with
significant unmet patient needs, and oncology. OPM's intellectual
property strategy effectively protects the value of this asset and
its use in a wide range of therapeutic indications.
About Oncodesign Precision Medicine (OPM)
Oncodesign Precision Medicine (OPM), the result of the transfer
of Oncodesign's Biotech and AI activities, is a biopharmaceutical
company specializing in precision medicine to treat resistant and
metastatic cancers.
OPM's innovative technologies are (i) OncoSNIPER for the
selection of therapeutic targets using artificial intelligence;
(ii) Nanocyclix® for the design and selection of macrocyclic small
molecule kinase inhibitors and (iii) Promethe for the design and
selection of radiolabeled biological molecules for systemic
radiotherapy.
From these technologies, OPM has built a portfolio of
therapeutic products. A first drug candidate based on the
Nanocyclix® technology entered the clinical phase in 2022, in
partnership with SERVIER (which exercised its option for an
exclusive worldwide license on the program) to treat Parkinson's
disease. OPM-101 is OPM's second candidate to enter the clinic, in
the treatment of chronic immuno-inflammatory diseases. Finally, OPM
is also collaborating with Servier to discover new therapeutic
targets for the treatment of pancreatic adenocarcinoma based on its
OncoSNIPER technology. In addition, OPM is seeking a partner for
Florepizol, a radiotracer specific for the mutated EGFR target,
which has successfully completed Phase I. Finally, OPM has a
significant portfolio of early-stage projects with Nanocyclix® and
Promethe in oncology. With this portfolio of molecules and
diversified therapeutic targets, OPM's mission is to discover
effective therapies to treat resistant and advanced cancers. Based
in Dijon, at the heart of the university and hospital cluster, OPM
has 25 employees.
More info at: oncodesign.com
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version on businesswire.com: https://www.businesswire.com/news/home/20231002368687/en/
OPM Karine Lignel Deputy General Manager Tel: +33 (0)3 80
78 41 93 investisseurs@oncodesign.com
NewCap Investor Relations Mathilde Bohin / Alban Dufumier
Tel: +33 (0)1 44 71 94 95 oncodesign@newcap.eu
NewCap Media Relations Arthur Rouillé Tel: +33 (0)1 44 71
00 15 oncodesign@newcap.eu
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