November 5, 2024 - 🧬 [nGram] Today’s Scoop: Damona's IND Clearance, NeuroPace's 3-Year Data, Teva's Phase 3 Results

1. Damona Pharmaceuticals receives FDA clearance for DPX-101 Phase 1 trial

   • Damona Pharmaceuticals announced FDA clearance for the IND application of DPX-101, targeting cognitive deficits in brain disorders.
   • The Phase 1 trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults.
   • The trial includes single- and multiple-ascending dose studies, with a comparator cohort using Zolpidem.
   • Exploratory endpoints will use qEEG to assess target engagement and differentiation from Zolpidem.
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2. NeuroPace submits three-year data from RNS System study to FDA

   • NeuroPace has submitted three-year safety and effectiveness data from its Post-Approval Study (PAS) of the RNS System to the FDA.
   • The study is the largest prospective trial in neuromodulation for drug-resistant focal epilepsy, enrolling over 300 patients.
   • The RNS System PAS is a five-year study required by the FDA to evaluate the RNS System as an adjunctive therapy.
   • The study will continue to a five-year follow-up endpoint, with future peer-reviewed publications anticipated.
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3. Medincell’s partner Teva unveils new phase 3 positive results for olanzapine LAI

   • Teva presented positive data from the Phase 3 SOLARIS trial for Olanzapine LAI in schizophrenia patients.
   • Significant improvements in social functioning and quality of life were observed from baseline to week 8.
   • No occurrences of Post-Injection Delirium/Sedation Syndrome (PDSS) were reported with Medincell's subcutaneous delivery technology.
   • Real-world data on UZEDY showed high adherence rates in adults with schizophrenia facing treatment barriers.
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4. NeuroBo Pharmaceuticals completes last patient visit in phase 2a trial for DA-1241

   • NeuroBo Pharmaceuticals has completed the last patient visit in its Phase 2a trial for DA-1241, targeting MASH.
   • The trial is divided into two parts: Part 1 compares DA-1241 to placebo, and Part 2 evaluates DA-1241 with sitagliptin.
   • A total of 109 patients were randomized, with 95 completing the dosing phase.
   • Topline data from both parts of the trial is expected in December 2024.
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5. Neurocrine Biosciences presents data on improvements in tardive dyskinesia with INGREZZA

   • Neurocrine Biosciences shared data from over 300 patients treated with INGREZZA at the 2024 Psych Congress.
   • Phase 3 and 4 studies showed significant improvements in quality of life measures for patients with tardive dyskinesia.
   • The KINECT-3 study met its primary endpoint with significant improvements in AIMS scores at week six.
   • Real-world data indicated that 93.9% of patients experienced improvement in tardive dyskinesia symptoms.
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6. Electra Therapeutics receives FDA fast track designation for ELA026 in secondary hemophagocytic lymphohistiocytosis

   • Electra Therapeutics has been granted FDA Fast Track designation for ELA026, a first-in-class antibody therapy.
   • ELA026 targets signal regulatory proteins (SIRP) to treat secondary hemophagocytic lymphohistiocytosis (sHLH), a rare and life-threatening disease.
   • Fast Track designation allows for accelerated development and review, with benefits like early FDA interactions and rolling submission of marketing applications.
   • sHLH is a hyperinflammatory disease with no approved treatments, often leading to severe outcomes without intervention.
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