Newron Pharmaceuticals — Positive interim trial results in schizophrenia

Newron Pharmaceuticals (SIX: NWRN)

Last close As at 16/07/2024

CHF8.32

0.26 (3.23%)

Market capitalisation

CHF159m

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Research: Healthcare

Newron Pharmaceuticals — Positive interim trial results in schizophrenia

Newron Pharmaceuticals’ share price has responded well to its announcement of encouraging interim efficacy data for the use of evenamide as an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). Patients who completed (85 out of 100) the six-month (30-week) treatment period (study 015) were found to show statistically significant and clinically meaningful improvements in the symptoms of psychosis. Importantly, the six-month data showed a sustained and continued improvement in key efficacy measures compared to results after six weeks (study 014) of treatment, with the proportion of patients achieving clinically meaningful improvements increasing over time. We view these latest results as highly supportive of evenamide’s clinical utility in TRS, further justifying management’s strategy of expanding into this schizophrenia patient population.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Newron Pharmaceuticals

Positive interim trial results in schizophrenia

Clinical trial update

Pharma and biotech

3 January 2023

Price

CHF1.55

Market cap

CHF28m

CHF0.99/€

Net debt (€m) at end June 2022

15.5

Shares in issue

17.8m

Free float

99%

Code

NWRN

Primary exchange

SIX Swiss Exchange

Secondary exchange

N/A

Share price performance

Business description

Newron Pharmaceuticals is focused on the central nervous system. Xadago for Parkinson’s disease is sold in Europe, Japan and the United States. Evenamide, a novel schizophrenia add-on therapy, is involved in a Phase II/III trial programme targeting schizophrenia patients experiencing inadequate responses to current antipsychotic medications.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Newron Pharmaceuticals is a research client of Edison Investment Research Limited

Newron Pharmaceuticals’ share price has responded well to its announcement of encouraging interim efficacy data for the use of evenamide as an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). Patients who completed (85 out of 100) the six-month (30-week) treatment period (study 015) were found to show statistically significant and clinically meaningful improvements in the symptoms of psychosis. Importantly, the six-month data showed a sustained and continued improvement in key efficacy measures compared to results after six weeks (study 014) of treatment, with the proportion of patients achieving clinically meaningful improvements increasing over time. We view these latest results as highly supportive of evenamide’s clinical utility in TRS, further justifying management’s strategy of expanding into this schizophrenia patient population.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

DPS
(%)

Yield
(%)

12/20

5.26

(18.16)

(1.09)

0.0

N/A

N/A

12/21

5.76

(14.12)

(0.79)

0.0

N/A

N/A

12/22e

6.60

(15.51)

(0.87)

0.0

N/A

N/A

12/23e

7.89

(16.41)

(0.92)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

It is estimated that 30–60% of schizophrenia patients are diagnosed with TRS, resulting in increased morbidity, mortality and suicide, and TRS continues to represent an unmet medical need. With the positive trial results, we see a clear opportunity for evenamide as the first potential add-on therapy in schizophrenia treatment.

As a reminder, study 014 is a six-week, open-label study, in which Newron had previously reported encouraging data from the first 100 patients enrolled and randomized to receive add-on evenamide at either 7.5mg, 15mg or 30mg doses. Of these, 90 patients continued onto the extension study (study 015) to observe longer-term safety and efficacy effects. Assessment of efficacy is based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) scales.

After 30 weeks of treatment, the proportion of patients demonstrating a clinically meaningful PANSS improvement more than doubled from that observed at week 6 (16.5%). Additionally, the CGI-S responder rate increased from 60% at week 6 by an additional c 20% at week 30, while the CGI-C responder rate also increased from 27% at week 6 by 10% at week 30. Notably, nearly all of the 100 evaluated patients to date has received either the 7.5mg or 15mg dose, hence there is potential for even greater benefit to be shown in the 30mg dose arm once the study is completed.

Final results from study 014 and extension study 015 are expected in March 2023 and Q124 respectively and management intends to initiate a pivotal Phase III randomized, double-blind, placebo-controlled study for evenamide in TRS in 2023.

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