-Statistically significant benefit demonstrated in primary endpoint of positive subscale of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) at Week 4-
-Dose-response was demonstrated, consistent with higher efficacy in the 40 mg dose-
-Favorable tolerability profile demonstrated relative to standard-of-care atypical antipsychotics-
-Investor call to be held 10th of July at 3 PM CEST with details provided below:
- MS Teams: https://teams.microsoft.com/l/meetup-join/19%3ameeting_NTA4ZDg0NzEtYjU2ZS00N2NjLWI4MjAtYzAwMzQxMDBhNDlj%40thread.v2/0?context=%7b%22Tid%22%3a%22dc816c94-0313-4f34-8ed1-1bff167d7003%22%2c%22Oid%22%3a%22640e4061-4b30-4b4f-ab73-ea6aee635b80%22%7d
- Telephone: +48 22 161 67 63, 522919119# Poland, Warsaw. 522 919 119#
WARSAW, Poland, July 09, 2024 (GLOBE NEWSWIRE) -- 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 Siewierska
inwestorzy@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
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