Noema Pharma's NOE-105 Phase 2a Study in Tourette Syndrome Meets All Endpoints

Noema Pharma AG, a company specializing in neuroscience-based treatments, has announced promising results from its Phase 2a ALLEVIA-1 study involving NOE-105 (gemlapodect) for Tourette syndrome (TS). This Phase 2a study, designed to investigate the efficacy and safety of gemlapodect, met its primary and key secondary endpoints. Gemlapodect, a novel PDE10A inhibitor, is being explored for its potential to alleviate vocal and motor tics in TS patients while offering a better tolerability profile than existing treatments.

The ALLEVIA-1 study was a multicenter, 12-week, open-label, single-arm monotherapy trial that included 15 participants with TS, averaging 26.2 years of age. Patients were treated with increasing doses of gemlapodect from 2.5 to 15 mg daily, aiming for a target dose range of 10 to 15 mg per day. The study’s primary and secondary objectives were successfully achieved.

Key findings from the study include:
- 57% of patients showed significant tic improvement based on the TS Clinical Global Impression of Change (TS-CGI-C). None of the patients experienced worsening symptoms.
- Among patients who completed the study within the target dose range, 87.5% showed improvement, and 75% were rated as "much" or "very much" improved on the TS-CGI-C.
- The Yale Global Tics Severity Scale Total Tic Score (YGTSS-TTS) demonstrated a mean improvement of -7.8 points for all patients from baseline to the study’s endpoint.
- For patients who completed the study within the target dose range, the YGTSS-TTS showed a mean improvement of -12.8 points.
- No serious adverse events, weight gain, or clinically significant changes in metabolic markers such as blood glucose or lipids were reported, underscoring the favorable safety profile of gemlapodect.

Ilise Lombardo, M.D., CEO of Noema Pharma, expressed optimism about the findings, stating, “We believe gemlapodect has the potential to offer a meaningful advancement in the treatment of Tourette syndrome.” Prof. Kirsten Mueller-Vahl, Principal Investigator at MHH in Hannover, Germany, added, “Tourette syndrome is a challenging condition that affects patients' daily lives. Current treatments often come with significant side effects. The results from the gemlapodect study are promising, providing hope for new treatment options.”

The initial data from this study were presented at the MDS 2024 Congress on September 28, 2024. The study's results highlight the importance of developing new treatments for Tourette syndrome, where current therapeutic options have notable limitations and side effects.

Noema Pharma is a clinical-stage biotech company focused on developing transformative treatments for neurological conditions with high unmet needs. The company has four active Phase 2 clinical trials addressing various conditions, with results expected in 2025. NOE-105, also known as gemlapodect, is a potential first-in-class phosphodiesterase-10A (PDE10A) inhibitor that modulates dopamine signaling in the brain's striatum region. It aims to provide a more targeted therapeutic effect for Tourette syndrome, minimizing off-target effects associated with other dopamine antagonists.

Tourette syndrome is a neurodevelopmental disorder characterized by motor and vocal tics, affecting over half a million people in the United States alone and millions worldwide. The condition significantly impacts the daily lives of patients and their families, creating a substantial need for effective and tolerable treatments.