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CHF256m
Research: Healthcare
Newron Pharmaceuticals has released additional data from its Phase II/III trial (study 008A), providing further evidence to support evenamide’s potential in schizophrenia. After four weeks of treatment, the mean score on the Clinical Global Impression of Change (CGI-C) scale, a key secondary efficacy measure, was 3.3 versus 3.5 for placebo, with the lower score translating to more favourable outcomes. Also, 31.3% of patients rated ‘much improved’ versus 17.3% on placebo. The update indicated that all the major efficacy measures increased over time, similar to the trend seen in the Phase II 014/015 study, albeit in a larger, randomised, placebo-controlled setting. The results highlight the drug’s potential as an effective long-term treatment in a segment with limited treatment options. As previously discussed, a potentially pivotal Phase III study in treatment-resistant schizophrenia (TRS) (study 017) is in the works, and expected to commence within 2024.
Written by
Newron Pharmaceuticals |
Evenamide potential for treatment of schizophrenia |
Clinical update |
Pharma and biotech |
14 May 2024 |
Share price performance
Business description
Analysts
Newron Pharmaceuticals is a research client of Edison Investment Research Limited |
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Newron Pharmaceuticals has released additional data from its Phase II/III trial (study 008A), providing further evidence to support evenamide’s potential in schizophrenia. After four weeks of treatment, the mean score on the Clinical Global Impression of Change (CGI-C) scale, a key secondary efficacy measure, was 3.3 versus 3.5 for placebo, with the lower score translating to more favourable outcomes. Also, 31.3% of patients rated ‘much improved’ versus 17.3% on placebo. The update indicated that all the major efficacy measures increased over time, similar to the trend seen in the Phase II 014/015 study, albeit in a larger, randomised, placebo-controlled setting. The results highlight the drug’s potential as an effective long-term treatment in a segment with limited treatment options. As previously discussed, a potentially pivotal Phase III study in treatment-resistant schizophrenia (TRS) (study 017) is in the works, and expected to commence within 2024.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
6.09 |
(16.99) |
(0.95) |
0.0 |
N/A |
N/A |
12/23 |
9.06 |
(16.00) |
(0.90) |
0.0 |
N/A |
N/A |
12/24e |
24.33 |
(2.6) |
(0.14) |
0.0 |
N/A |
N/A |
12/25e |
27.06 |
(0.8) |
(0.04) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The latest data provides incremental context on the efficacy measures evaluated in study 008A. The study data reported a mean rating of 3.3 on the CGI-C scale for the evenamide arm versus 3.5 for the placebo arm, with high statistical significance (p-value <0.001). The seven-point CGI-C rating scale indicates the response to treatment, with lower scores translating to better outcomes. In addition, 31.3% of patients rated as ‘much improved’ in the evenamide arm versus 17.3% for placebo (p-value=0.006). The results demonstrated that the efficacy and outcomes continued to improve with incremental time on treatment, in line with long-term data seen from the Phase II 014/015 study in TRS. We see this as a key observation, given that schizophrenia patients typically develop resistance to antipsychotic treatment modifications. Given the limited treatment options and positive data, there seems to be potential for evenamide as a sustainable long-term treatment for schizophrenia, should the clinical data in study 017 continue to be supportive.
This data supplements the recent top-line results from study 008A, which met its primary endpoint (improvement on the Positive and Negative Syndrome Scale (PANSS)) and a key secondary endpoint (improvement on the Clinical Global Impression of Severity, CGI-S, scale) with statistical significance. Study 008A was a four-week, randomised, double-blind, placebo-controlled Phase II/III trial, evaluating safety, tolerability and efficacy in 291 patients with poorly managed schizophrenia already on antipsychotics, but not classed as having TRS. Based on the 008A results, Newron plans to make certain modifications to the upcoming, potentially pivotal, randomised Phase III trial design in TRS (study 017), before commencing recruitment. Following the positive data from study 015 and study 008A, we expect Newron to first secure a partnership deal for evanamide before initiating Phase III (estimated by Q424). The current cash balance provides headroom to 2025.
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Research: TMT
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