Keyzilen (esketamine) / Altamira Therap - LARVOL DELTA

Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: University of Cincinnati | Trial completion date: Jun 2024 ➔ Jun 2027 | Trial primary completion date: Jan 2024 ➔ Jan 2026

Trial completion date • Trial primary completion date

Design, Synthesis, and Biological Evaluation of a Novel Long-Acting Human Complement C3 Inhibitor Synthesized via the PASylation-Lipidation Modular (PLM) Platform. (PubMed, Bioconjug Chem) - "CP40 (a cyclic peptide also known as AMY101), effectively inhibits complement activation by preventing the initial binding of the C3 substrate to convertase. In a clinically relevant in vitro model of complement-mediated hemolysis in PNH, 6C1 effectively reduced erythrocyte lysis. The PLM platform thus offers a versatile strategy for enhancing peptide therapeutics by improving solubility, extending circulation time, and increasing efficacy, broadening their therapeutic potential."

Journal • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

NMDA Receptors: Next therapeutic targets for Tinnitus? (PubMed, Biochem Biophys Rep) - "Clinical trials of NMDAR antagonists, such as acamprosate, caroverine, neramexane, and AM-101, have shown promising results, though none are yet approved. These findings highlight the need for further research on NMDARs to advance the development of next-generation targeted pharmacological therapies for tinnitus."

Journal • Review • Neuralgia • Otorhinolaryngology • Pain

Levocarnitine Improves Heat Stress Survival in Caenorhabditis Elegans Model of Polyglutamine Disorders (HSG 2024) - "elegans) model of polyglutamine disorders. We utilized C. elegans strains N2, AM101, and WLZ3, representing wild type, polyglutamine disorders model (40 CAG repeats), and Parkinson's disease (PD) model, respectively... Levocarnitine significantly enhances heat stress tolerance in C. elegans model of polyglutamine disorders, indicating potential beneficial utility for Huntington's disease. Further research is needed to elucidate the underlying mechanisms of this phenomenon."

CNS Disorders • Huntington's Disease • Metabolic Disorders • Movement Disorders • Parkinson's Disease

GABA(A) Receptor Activation Drives GABARAP-Nix Mediated Autophagy to Radiation-Sensitize Primary and Brain-Metastatic Lung Adenocarcinoma Tumors. (PubMed, Cancers (Basel)) - "Employing a human-relevant ex vivo 'chip', AM-101 is as efficacious as docetaxel, a chemotherapeutic used with radiotherapy for advanced-stage NSCLC. This supports a model of GABA(A) receptor activation driving a GABARAP-Nix multimerization axis that triggers autophagy. In patients receiving radiotherapy, GABA(A) receptor activation may improve tumor control while allowing radiation dose de-intensification to reduce toxicity."

Journal • Metastases • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • GABARAP • UBB

Synthesis and activity of AM-101 in medulloblastoma, melanoma and non-small cell lung cancers (ACS-Fall 2023) - "AM-101 enhances the infiltration of anti-tumor immune cells and it can treat primary site and metastatic lesions of different solid tumors. This study shows AM-101 combined with radiation results in a significant reduction in the volume of cancer tumors, and the 'add on' works just as well with checkpoint inhibitors."

Brain Cancer • Lung Cancer • Medulloblastoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: University of Cincinnati | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Apr 2023

Enrollment open • Trial initiation date

Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction. (PubMed, J Am Coll Cardiol) - P3 | "Patients with a history of prior MI in REDUCE-IT treated with IPE demonstrated large and significant relative and absolute risk reductions in ischemic events, including CV death. (A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. [REDUCE-IT]; NCT01492361)."

Journal • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Hypertriglyceridemia • Myocardial Infarction

Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. (PubMed, J Am Coll Cardiol) - P3 | "IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361)."

Journal • Cardiovascular • Hypertriglyceridemia • Myocardial Infarction

An update: emerging drugs for tinnitus. (PubMed, Expert Opin Emerg Drugs) - "Areas covered: In this editorial results from recent Phase 3 and Phase 2a trials investigating the NMDA receptor antagonist AM-101 from Auris Medical, the AMPA receptor antagonist BGG492 from Novartis and the Kv3 modulator AUT00063 from Autifony Therapeutics will be discussed. Expert opinion: In spite of huge advances in pathophysiologic knowledge and research methodology in the last decades, pharmaceutical research in tinnitus still represents a high-risk field. Important research directions include the identification of potential therapeutic targets and the development of objective outcome measurements to facilitate translational research."

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