Newron announces initiation of new clinical trial with Evenamide in patients
with schizophrenia, following approval of plan by FDA
Milan, Italy and Morristown, NJ, USA, January 9, 2020 - Newron Pharmaceuticals S.p.A.
(“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development
of novel therapies for patients with diseases of the central and peripheral nervous system,
announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA)
on the design and conduct of explanatory studies with Evenamide required to address previously
announced potential safety issues raised by the FDA. Newron is developing Evenamide as the
potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
In May 2019, the FDA requested that Newron complete additional short-term explanatory studies in
rats and human subjects to address concerns on findings from a recently completed study of
Evenamide in rats, as well as CNS events observed following high dose administration of Evenamide
in dogs. Newron met with the FDA on August 28, 2019, to discuss the issues, the proposed plans
for these studies and the eventual start of the Phase III program with Evenamide. The FDA approved
the plan proposed by Newron as well as the protocol for a first, four-week explanatory study in
patients with schizophrenia, which is expected to start enrolling patients in the next few days. Newron
expects initial results from the additional studies in rats and humans in Q3 2020.
Subject to the successful completion of these studies, Newron intends to commence its proposed
Phase III clinical trial program with Evenamide for patients with schizophrenia experiencing
worsening of psychosis on atypical antipsychotics, and for treatment-resistant patients not
responding to the antipsychotic drug clozapine.
“We are pleased to announce not only the FDA’s concurrence with the plan for these additional
short-term studies with Evenamide, but also their approval of the first clinical protocol that will start
enrolment in the next few days,” said Ravi Anand, Newron’s Chief Medical Officer. “The initiation of
these studies in humans represents progress in addressing the issues raised by the FDA in May
2019. We expect to submit initial results to the FDA in Q3 2020, and the results from the next study
in patients in Q4 2020. The acceptance of these results from studies in humans together with the
results of the additional toxicology studies should allow us to start the Phase III clinical program in
schizophrenia patients shortly thereafter.”
About Evenamide
Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of
schizophrenia. Evenamide is an orally available New Chemical Entity that specifically targets voltage-gated sodium
channels for the treatment of schizophrenia. The compound originates from Newron’s ion channel program and has a
unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates
sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release
induced by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated Evenamide’s evidence of
efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly
prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that Evenamide is devoid
of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.