The Board of Directors' decision on a new execution strategy and prioritisation of clinical areas in Reponex Pharmaceuticals A/S.
13 Dezember 2024 - 12:21PM
UK Regulatory
The Board of Directors' decision on a new execution strategy and
prioritisation of clinical areas in Reponex Pharmaceuticals A/S.
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The Board of Directors' decision on a new execution strategy and
prioritisation of clinical areas in Reponex Pharmaceuticals
A/S. |
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December 13, 2024
Announcement No. 32
Pharma Equity Group conducts continuous evaluation of the clinical
pipeline of Reponex Pharmaceuticals A/S (Reponex) based on a number
of fundamental commercial criteria, including medical need, patient
recruitment, regulatory requirements, likelihood of success and
requirements for both human and monetary capital.
Based on this evaluation, Reponex has chosen to give top priority
to the following development programmes:
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RNX-051 for Colon Adenomas and Colon Cancer
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RNX-011 for the Treatment of Peritonitis
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RNX-041 for the treatment of IBD (pouchitis)
The mentioned development programs have all shown relevant,
informative and strong clinical data, and have obtained patent
protection in the most important geographical areas for the
company.
In recent months, the Company and its clinical partners have
therefore allocated significant resources to the final preparations
and finalization of the study protocols for the submission of the
Phase 2 clinical trial applications to the authorities. The trial
applications for RNX-011 and RNX-051 are expected to be submitted
to the authorities at the beginning of Q1-2025 and the end of
Q1-2025, respectively.
In Q1-2025, Reponex will implement laboratory models based on blood
samples from patients with peritonitis and used to confirm the
disease mechanisms that RNX-011 affects. Through these results, the
correct dosage of the drug will be tested on the patient's blood
sample and thereby generate an ongoing data package. The initiative
will not only support clinical studies, but enable
individualisation of the treatment of patients with
peritonitis.
RNX-041 is actively included in Part 2 of the ongoing Phase 2
proof-of-concept clinical study for the treatment of pouchitis.
The studies are conducted as investigator-initiated studies (IITs),
designed in compliance with guidelines from the FDA and EMA as well
as expected requirements from future industrial license partners.
In addition, it is emphasized that the study design enables
continuous analysis and release of data.
The company works continuously to establish strategic partnerships
– a process that will continue during the completion of the
studies.
The company has unblinded the proof-of-concept study with RNX-021
for the treatment of chronic venous leg ulcers. As expected, data
from the proof-of-concept study provide the company with
significant and valuable information for use in the continued
formulation work with a focus on optimizing the drug candidates for
future clinical studies with RNX-022 and RNX-023.
The Company's drug candidates in the treatment of chronic leg
ulcers (RNX-022, RNX-023) and Crohn's Disease (RNX-041) continue to
be considered of great interest both clinically and commercially.
These programmes will be pursued through strategic clinical and
industrial cooperation.
For further information, please contact:
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Thomas Kaas
Selsø, CEO of Pharma Equity Group A/S, phone: +45 4022 2114
Christian Vinding Thomsen, Chairman of the Board of Directors of
Pharma Equity Group A/S, phone: +45 2622 7222 |
About Pharma Equity Group A/S
Pharma Equity Group, a listed company on the
Nasdaq Copenhagen stock exchange, is fully dedicated to advancing
the medical projects of its subsidiary, Reponex Pharmaceuticals
A/S. With an unwavering focus on healthcare, Pharma Equity Group's
primary objective is to bring significant value to Reponex
Pharmaceuticals' medical projects.
The company is committed to providing extensive support,
resources, and expertise to drive the development and success of
these projects. As a strategic partner, Pharma Equity Group works
closely with Reponex Pharmaceuticals, prioritizing the advancement
of innovative medical solutions and breakthrough therapies. Every
effort is currently directed towards ensuring the utmost success
and impact of Reponex Pharmaceuticals' medical projects, with an
unwavering dedication to improving global healthcare outcomes. Only
when the full potential of Reponex Pharmaceuticals has been
unfolded is the intention to explore opportunities to invest in
other companies. This approach ensures a strong commitment to the
current medical projects and their development, while – on the
longer term – remaining open to new strategic investments for
continuous growth.
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