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CHF256m
Research: Healthcare
Newron has presented new efficacy data from its Phase II evenamide trial (study 014/015) at the CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society. These data, from the first 100 patients at the one-year timepoint, indicate significant and clinically important results, with continuous improvements across the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) efficacy scales. While we anticipate full one-year results from the evenamide extension trial (study 015) in Q124, the company plans to initiate a potentially pivotal multinational Phase III trial (study 003) in treatment-resistant schizophrenia (TRS) patients in H223, which in our view, represents an important catalyst.
Written by
Newron Pharmaceuticals |
Encouraging efficacy data from evenamide trial |
Clinical trial update |
Pharma and biotech |
16 May 2023 |
Share price performance
Business description
Analysts
Newron Pharmaceuticals is a research client of Edison Investment Research Limited |
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Newron has presented new efficacy data from its Phase II evenamide trial (study 014/015) at the CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society. These data, from the first 100 patients at the one-year timepoint, indicate significant and clinically important results, with continuous improvements across the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) efficacy scales. While we anticipate full one-year results from the evenamide extension trial (study 015) in Q124, the company plans to initiate a potentially pivotal multinational Phase III trial (study 003) in treatment-resistant schizophrenia (TRS) patients in H223, which in our view, represents an important catalyst.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
5.76 |
(14.12) |
(0.79) |
0.0 |
N/A |
N/A |
12/22 |
6.09 |
(16.99) |
(0.95) |
0.0 |
N/A |
N/A |
12/23e |
6.46 |
(17.11) |
(0.96) |
0.0 |
N/A |
N/A |
12/24e |
6.85 |
(22.27) |
(1.25) |
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 update from study 015 provides full efficacy data for 100 patients at the one-year timepoint, assessed by changes from baseline across the PANSS, CGI-C, CGI-S and LOF scales. We note that the primary objective of the study is to evaluate the safety and tolerability of evenamide (at three fixed doses of 7.5mg, 15mg and 30mg bid), with PANSS being the primary efficacy indicator. The results showed an increased reduction in the PANSS total score at all timepoints versus baseline, with a PANSS responder rate (defined as showing a >20% improvement) of 47%, a 3x increase from 16% at week six. The CGI-C scale measurements showed that 41% of patients were rated as ‘much’ or ‘very much’ improved versus baseline. CGI-S measurements showed improvements of 1.1 units versus baseline, with 29% of patients observing two or three category improvements.
Overall, 38% of patients met the threshold for being classified as ‘super-responders’ (described as a ‘full responder’ in a previous update from the company), defined by: a PANSS total score improvement of at least 20%; a CGI-C of at least ‘much improved’; a CGI-S of an at least one point improvement and at most ‘mildly ill’. This represents a 2.5x increase from week six, which in our view is supportive of evenamide as potentially the first add-on therapy for TRS patients.
As a reminder, the Phase II evenamide trial (study 014, six weeks and study 015, an extension study) is an international, randomised, open-label, rater-blinded assessment of evenamide (safety and efficacy) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS. With the encouraging efficacy data to date, we anticipate that improvements in clinical benefit over a longer period (in line with the observed trend for the first 100 patients), and systematic differences between doses of evenamide, if observed, will become clearer with time. One-year data from the full 161-patient cohort in extension study 015 are expected in Q124.
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Research: Healthcare
Biodexa has reported its FY22 preliminary results and revised business strategy for the medium term. Funding challenges and slower traction than anticipated with the clinical pipeline during the period compelled the company to undertake cost-reduction initiatives (terminating all internal Q Sphera development programs) and pivot its business model from a drug delivery company to a therapeutics play in March 2023 (along with a name change, AIM delisting and share consolidation). Looking ahead, we expect the strategic focus to be on delivering proof-of-concept (PoC) for its development pipeline, in particular for lead Phase I asset MTX110 (in aggressive brain cancers). The $6m (£5m) equity raise in February provides a runway to Q423, past the crucial interim safety and efficacy data from the Phase I recurrent glioblastoma (rGBM) study anticipated in Q323. Potential licensing deals on the back of positive MTX110 data should provide operational headroom and de-risk the near-term outlook.