Positive data from schizophrenia clinical trials revealed

Utilising an add-on therapy for treatment-resistant schizophrenia (TRS)

Newron Pharmaceuticals SPA has reported significant final, one-year results from its clinical trial 014/015, evaluating evenamide as an add-on therapy to antipsychotics in treatment-resistant schizophrenia (TRS).

Evenamide

According to Newron, evenamide is an orally available new chemical entity that normalises glutamate release induced by aberrant sodium channel activity (veratridine-stimulated). It does not affect basal glutamate levels, due to inhibition of voltage-gated sodium channels (VGSCs).

What did the data show?

“Treatment with evenamide as an add-on to antipsychotics in treatment-resistant schizophrenia (TRS) patients has produced benefits that have never been reported before,” Ravi Anand, Newron’s Chief Medical Officer shared.

The findings saw that over 70 percent of the patients with treatment-resistant schizophrenia (TRS) experienced a clinically significant reduction in disease severity.

Newron emphasised that in contrast to common clinical experience, no patient relapsed during the one-year treatment period.

“The finding that 25 percent of TRS patients achieved remission is very unexpected. These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted.

“Although these data are derived from an open-label clinical trial, the increasing benefit over time from six-weeks to one-year suggests that the glutamate modulating effect of evenamide could lead to a progressive and long-standing alteration in brain processes synergising with the effect of antipsychotics to which the patient had become resistant. The above results, if replicated, would transform not only the management but also the societal outlook for patients with treatment-resistant schizophrenia,” Anand added.

Therefore, these results support the idea that adding a glutamate modulator to background antipsychotics can benefit treatment-resistant schizophrenia (TRS) patients.

Weekly risperidone versus daily Risperdal for schizophrenia

Positive data from Lyndra Therapeutics^® clinical trial STARLYNG-1 (LYN-005-C-301), comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with daily immediate-release Risperdal in those with schizophrenia and schizoaffective disorder, has been released.

The Phase III STARLYNG-1 clinical study is designed to bridge to the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the US Food and Drug Administration.

A single dose of oral weekly risperidone delivers comparable medication levels to daily risperidone, Lyndra Therapeutics’ Chief Medical Officer and President of Global Product Development Dr Richard Scranton described what the data found.

One key potential benefit of Lyndra’s drug delivery platform used in the clinical trial is that it can deliver more consistent levels of medication via a once-a-week regime, the company highlighted. This is compared to daily dosing, therefore helping to reduce the peak to trough variation patients can experience.

“For people who rely on risperidone as part of their treatment regime, oral weekly risperidone could vastly improve medication adherence and outcomes,” Dr Scranton added.

Based on the results, the clinical trial was stopped early. “We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024,” Jessica Ballinger, Lyndra Therapeutics’ President and CEO commented.