Celon Pharma S.A. (CLN.WA) announces today robust and positive
Phase 2 clinical trial results for its PDE10A inhibitor (CPL’36), a
novel, oral, once-daily antipsychotic. Statistically significant
and clinically meaningful improvements in the primary endpoint of
positive subscale of the PANSS were seen in both tested doses of
CPL’36, with a dose-response effect. Management plans to discuss
these highly encouraging results with regulatory agencies to
advance CPL’36 towards registrational trials and global marketing
approvals. Additionally, CPL’36 is being investigated as a
potential treatment for levodopa-induced dyskinesia in Parkinson’s
disease, with Phase 2 results expected to be reported in 4Q 2024.
“The results from this Phase 2 trial suggest a
beneficial effect of CPL’36 across multiple aspects of
schizophrenia pathophysiology. Clinical efficacy was deemed strong,
and moreover, the drug tolerability was quite favorable,”
confirmed Maciej Wieczorek, Ph.D., CEO of Celon Pharma
S.A. “We believe that these results could herald a
breakthrough in the treatment of this disease that impacts over 24
million patients world-wide, by identifying an innovative drug
class with a new mechanism of action that may be used to replace or
complement the current standard of care. These results represent a
lengthy and satisfying journey for Celon as we have been closely
analyzing the competitive environment in schizophrenia and the
clinical trial designs of major international companies working on
PDE10A inhibitors. We are therefore proud to have developed a drug
characterized by unprecedented efficacy, with global potential to
help underserved patients,” he concluded.
Trial description
The CPL’36 Phase 2 study was an international,
multicenter, randomized, placebo-controlled clinical trial
conducted on a group of 189 adult patients hospitalized due to
acute schizophrenia.
CPL’36 was administered for 4 weeks in two doses
of 20 and 40 mg once daily and was placebo-controlled at a ratio of
1:1:1. Patient baseline severity was moderate-severe to severe, as
characterized by a PANSS total score of approximately 106. Patients
were screened for up to 10 days and then randomized and treated
over a four-week period, at which time the primary endpoint
assessment was conducted at Day 28.
At Week 4 of treatment, the reduction in
positive PANSS subscale score which was the primary endpoint in the
trial was 3.7 units from baseline in the 20 mg dose (LS mean
difference from placebo, p<0.001, Cohen’s d: 0.73), and 6.3
units in the 40 mg dose (LS Mean difference from placebo,
p<0.001, Cohen’s d: 1.38).
For total PANSS score at week 4 of treatment (a
key secondary endpoint), the 20 mg dose of CPL’36 demonstrated a
9.7 unit reduction from baseline compared to placebo (LS mean
difference from placebo, p<0.001, Cohen’s d: 0.77), and 16.4
units in the 40 mg dose (LS mean difference from placebo,
p<0.001, Cohen’s d: 1.47).
Other secondary endpoints in the trial included
the effects of CPL’36 on overall clinical improvement cognitive
performance and functioning such as Clinical Global Impression
Scale Improvement (CGI-I), Brief Assessment of Cognition in
Schizophrenia (BACS), and number of participants who withdraw due
to adverse events (AEs). Results across all of these endpoints were
also positive.
Drug tolerability was favorable with most
treatment emergent adverse events characterized as mild.
Exacerbations of schizophrenia represented the most common severe
adverse events that were potentially related to the drug (1.5% in
the placebo group, 1.8% in the 20 mg group and 3.1% in the 40 mg
group). Treatment discontinuation due to adverse events likely
related to the drug occurred in 3.1% patients in the placebo group,
0% patients in the 20 mg group and 7.7% patients in the 40 mg
group.
Investor Call Information:
Małgorzata
Siewierskainwestorzy@celonpharma.com+48519066531
ABOUT CELON PHARMA
Celon Pharma is an integrated biopharmaceutical
company which designs, develops, manufactures and distributes
pharmaceutical products. It was founded in 2002 by Maciej
Wieczorek, PhD. The Company currently has approx. 500 employees. It
employs approx. 160 scientists responsible for research and
development, half of whom either have a PhD or are in the process
of acquiring their PhD. The Company's pipeline includes more than a
dozen projects for the development of innovative drugs with
therapeutic groups such as oncology, neuro-psychiatry, autoimmunity
and metabolism. The Company has its own research and development
laboratories, which allow it to develop its own pharmaceutical
technologies by using extensive laboratory equipment resources, as
well as the experience and expertise of its staff. It also has a
modern manufacturing facility where dry pharmaceutical forms are
manufactured. Over the last few years, the Company has introduced
products into the market in the following therapeutic areas:
oncology, central nervous system diseases, cardiology, respiratory
diseases. The Company has been developing the technology for
manufacturing inhalation drugs and several projects of innovative
drugs since 2007. It has been listed on the Warsaw Stock Exchange
since 2016. www.celonpharma.com
DisclaimerThis press release
(“Press release”) has been prepared by Celon Pharma S.A. (the
“Company”). By reading the Press release, you agree to be bound by
the following limitations.
This Press release is strictly confidential to
the recipient. Neither this Press release or any part hereof nor
the information contained herein may be reproduced or
redistributed, passed on, or the contents otherwise divulged,
directly or indirectly, to any other person or published, in whole
or in part.
If you gain access to this Press release by
mistake, or you are not an addressee of this Press release or a
person authorized to use this Press release, please bear in mind
the confidential nature of this Press release and immediately
contact the Company in order to return it to the Company.
The Press release does not constitute an offer
to sell or subscribe for or a solicitation of an offer to purchase
or subscribe for securities. This Press release is provided for
informational purposes only. This Press release does not constitute
or form part of and should not be construed as an offer,
solicitation or invitation to sell or issue, or an offer,
solicitation or invitation to, subscribe for, underwrite, buy or
otherwise acquire, securities of the Company or any of its
subsidiaries in any jurisdiction, or an inducement/recommendation
to enter into investment activity in any jurisdiction. Neither this
Press release nor any part hereof, nor the fact of its distribution
or issuance, shall form the basis of, or be relied on in connection
with, any contract, commitment or investment decision
whatsoever.
The information contained herein is only
preliminary and indicative and does not purport to contain the
information that would be required to evaluate the Company, its
financial position and/or any investment decision. This Press
release is not intended to provide, and should not be relied upon
for, accounting, legal or tax advice nor does it constitute an
investment recommendation. This Press release is given in
conjunction with an oral press release and should not be taken out
of context.
No information included in this Press release
may be considered as investment advice or investment
recommendation. The information contained in the Press release has
not been independently verified. No repress release, warranty or
undertaking, expressed or implied, is made as to, and no reliance
should be placed on, the fairness, accuracy, completeness or
correctness of the information or the opinions contained
herein.
Matters discussed in this Press release may
constitute forward-looking statements. Forward-looking statements
constitute statements that are other than statements of historical
fact. Statements which include the words “expects”, “intends”,
“plans”, “believes”, “projects”, “anticipates”, “will”, “targets”,
“aims”, “may”, “would”, “could”, “continue” and similar statements
of a future or forward-looking nature identify such forward-looking
statements. Forward-looking statements include in particular
statements regarding the financial performance, business strategy,
plans and objectives of the Company for future operations
(including growth potential). All forward-looking statements
included in this Press release address matters that involve known
and unknown risks, uncertainties and other factors which could
cause the Company’s actual results, performance or achievements to
differ materially from those indicated in such forward-looking
statements and from past results, performance or achievements of
the Company. Such forward-looking statements are based upon various
assumptions and estimates regarding future events, including
numerous assumptions regarding the Company’s present and future
business strategies and future operating environment. Although the
Company believes that these estimates and assumptions are
reasonable, they may prove to be incorrect.
The information, opinions and forward-looking
statements contained in this Press release speak only as at the
date of this Press release and are subject to change without
notice. The Company, its directors, agents, employees and advisors
do not intend to, and expressly disclaim any duty, undertaking or
obligation to, make or disseminate any supplement, amendment,
update or revision to any of the information, opinions or
forward-looking statements contained in this Press release to
reflect any change in events, conditions or circumstances. To the
extent permitted under the applicable provisions of law, neither
the Company nor any of their affiliates, advisers or
representatives shall have any liability whatsoever (in negligence
or otherwise) for any loss however arising from any use of this
Press release or its contents or otherwise arising in connection
with this Press release.
This Press release is not for distribution or
use by any person or entity in any jurisdiction where such
distribution or use would be contrary to local law or regulation or
which would subject the Company or any of its affiliates to
authorization, notification, licensing or other registration
requirements under applicable laws. Any failure to comply with this
restriction may constitute a violation of United States securities
laws. Persons into whose possession this Press release comes should
observe all such restrictions.
Obtain more information by
contacting:Małgorzata Siewierskamedia@celonpharma.com