NanoLithium (low-dose lithium microemulsion) / Medesis - LARVOL DELTA

Effect of sintering temperature on crystal structure, optical and thermal properties, and surface roughness and topography of nanolithium disilicate and zirconia-reinforced nanolithium silicate ceramics. (PubMed, J Oral Sci) - "Sintering temperature did not affect the evaluated properties of NLDS. However, sintering ZNLS at different temperatures might affect the tested properties."

Journal • TGFB2

NanoLi®_AD: Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease (clinicaltrials.gov) - P2 | N=72 | Completed | Sponsor: Medesis Pharma SA | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Oct 2024

Trial completion • Trial completion date • Alzheimer's Disease • CNS Disorders

Isolation and identification of a novel goose-origin reovirus GD218 and its pathogenicity experiments. (PubMed, Front Vet Sci) - "In terms of genomic structure and sequence homology, GD218 closely resembles the novel duck reovirus, differing significantly from earlier isolated NDRV strains (J18, NP03, SD12, etc.) in genetic composition (nt: 80.6-97.9%, aa: 94.3-98.9%). However, it is similar to strains isolated after 2018, such as XT18, SY, QR, YL, LY20, etc. (nt: 95.3-98.9%, aa: 98.6-99.7%). Therefore, based on phylogenetic analysis, GD218 is hypothesized to be a novel type of goose-origin reovirus homologous to the novel duck reovirus."

Journal • Hematological Disorders • Hepatology • Infectious Disease • Inflammation

Geographical variation and genetic diversity of Parashorea chinensis germplasm resources. (PubMed, Front Plant Sci) - "Based on our results, NP03 and ML02 germplasm could be used as the parents for breeding superior germplasm of P. chinensis. Overall, this study provides valuable insights into germplasm diversity and conservation, genetic improvement, and utilization of P. chinensis."

Journal

Nanolithium, a New Treatment Approach to Alzheimer's Disease: A Review of Existing Evidence and Clinical Perspectives. (PubMed, J Prev Alzheimers Dis) - "We highlight key aspects of the study design. We finish this review with a discussion on the potential place of Nanolithium in the current and future Alzheimer's disease treatment landscape."

Journal • Review • Alzheimer's Disease • CNS Disorders • Mental Retardation • Psychiatry

Meloidogyne enterolobii-induced Changes in Guava Root Exudates Are Associated With Root Rotting Caused by Neocosmospora falciformis. (PubMed, J Nematol) - "Only the fractions NP-03 and NP-04 enabled fungal root rotting...In conclusion, parasitism by M. enterolobii causes an enrichment of guava root exudates that likely favors microorganisms capable of producing 1,5-dinitrobiuret in the rhizosphere. The accumulation of biuret, a known phytotoxic substance, possibly hampers root physiology and the innate immunity of guava to N. falciformis."

Journal

Nanolithium has a dual potential in Alzheimer's disease: to treat Neuropsychiatric Symptoms and modify disease course (CTAD 2023) - P2 | "The ongoing proof-ofconcept clinical study on Nanolithium in AD (NCT05423522) aims to exemplify the clinical efficacy of Nanolithium versus placebo, on the progression of neuropsychiatric symptoms between baseline and 12 weeks, supporting a symptomatic effect. Early intervention on neuropsychiatric symptoms and proper management has also been proposed as a mean to slow disease progression for patients with such manifestations. Analysis of the effect on Nanolithium after 9 to 12 months (depending on treatment arm) on each NPI-12 items, could also help identifying a subset of patients who can particularly benefit from early treatment with Nanolithium."

Alzheimer's Disease • CNS Disorders • Inflammation • Psychiatry • BDNF

NanoLi®_AD: Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: Medesis Pharma SA | Trial completion date: Jun 2024 ➔ Apr 2025 | Trial primary completion date: May 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • BDNF

A Proof-of-Concept Study to Evaluate Efficacy of Nanolithium on the Progression of the Neuropsychological Symptoms in Patients with Mild-to-Severe Alzheimer’s Disease. (AAIC 2023) - "Using Aonys® to overcome challenges of lithium benefit/risk profile could be the path to demonstrate its potential as a therapeutic option in treating NPS in AD. Further, this study, will build up the body of evidence of Nanolithium effect on cognitive symptoms and disease modifying potential."

Clinical • Alzheimer's Disease • CNS Disorders • BDNF

MEDESIS PHARMA: FAVORABLE REPORT FROM IDSMB EXPERTS ON THE ONGOING PHASE 2 CLINICAL STUDY ON NANOLITHIUM IN THE TREATMENT OF ALZHEIMER'S DISEAS (Market Screener) - "MEDESIS PHARMA...announces the receipt on May 22, 2023 of the account report by experts from the IDSMB (Independent Data and Safety Monitoring Board, composed of medical experts in Alzheimer's disease and a biostatistician). This review of the safety data recommends continuing the study, in line with Medesis Pharma's expectations....The Phase 2 clinical study is underway on 68 Alzheimer's patients in 8 Hospital Centers in France....Currently, 43 patients have been included in the clinical study. The results of the first phase are expected at the end of 2023, and under these conditions the results of the complete study could come in the 3rd quarter of 2024."

DSMB • P1 data • Trial status • Alzheimer's Disease • CNS Disorders • Huntington's Disease

NanoLi®_AD: Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: Medesis Pharma SA | Trial completion date: Feb 2024 ➔ Jun 2024

Trial completion date • Alzheimer's Disease • CNS Disorders • BDNF

A PROOF-OF-CONCEPT STUDY TO EVALUATE EFFICACY OF NANOLITHIUM ON THE PROGRESSION OF NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS WITH MILD-TO-SEVERE ALZHEIMER’S DISEASE. (CTAD 2022) - "Study has been initiated in 6 centers in France, primary outcomes at 12 weeks intermediate analysis are expected beginning of 2023, final outcomes are expected end of 2023 - Beguining of 2024."

Clinical • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry • BDNF • THY1

NanoLi®_AD: Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: Medesis Pharma SA

New P2 trial • Alzheimer's Disease • CNS Disorders • BDNF

[VIRTUAL] COMBINATION OF MICRODOSE LITHIUM NP03 AND S-ADENOSYLMETHIONINE ALLEVIATES COGNITIVE DEFICITS AND AMYLOID-DRIVEN PATHOLOGY IN MCGILL-R-THY1-APP RATS (ADPD 2021) - "Complex conditions such as Alzheimer’s disease call for preventive and treatment interventions that can engage several targets simultaneously. Our findings provide preclinical evidence suggesting that combined treatment with NP03 and SAM could be a promising, non-amyloid targeted, therapeutic approach in the early stages of Alzheimer’s disease."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders

NP03, a Microdose Lithium Formulation, Blunts Early Amyloid Post-Plaque Neuropathology in McGill-R-Thy1-APP Alzheimer-Like Transgenic Rats. (PubMed, J Alzheimers Dis) - "In addition, NP03 reduces markers of neuroinflammation and cellular oxidative stress. Together these results indicate that microdose lithium NP03 is effective at later stages of amyloid pathology, after appearance of Aβ plaques."

Journal • Preclinical • Alzheimer's Disease • Amyloidosis • CNS Disorders • Immunology • Inflammation

[VIRTUAL] Combined treatment with the microdose lithium formulation NP03 and S-adenosylmethionine reduces cognitive decline and Alzheimers-like amyloid pathology in McGill-R-Thy1-APP rats (AAIC 2020) - "Our findings provide preclinical evidence suggesting that combined treatment with NP03 and SAM may be of therapeutic value in the early stages of Alzheimers disease."

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Immunology

The genomic constellation of a novel duck reovirus strain associated with hemorrhagic necrotizing hepatitis and splenitis in Muscovy ducklings in Fujian, China. (PubMed, Mol Cell Probes) - "Potential recombination events detection in segment L1 suggests that NP03 strain may be recombinants of novel WRVs. Based on our genetic analyses, multiple reassortment events, intra-segmental recombination, and accumulation of point mutations have possibly contributed to the emergence of this novel genotype of WRV, identified in China."

Journal • Hematological Disorders • Immunology

[VIRTUAL] A COMBINED THERAPY WITH S-ADENOSYLMETHIONINE AND MICRODOSE LITHIUM REDUCES AMYLOID PATHOLOGY IN A RAT MODEL OF ALZHEIMER’S-LIKE AMYLOIDOSIS (AAT-ADPD 2020) - "Aims Alzheimer’s disease is a multi-faceted disease and therefore treatment with compounds engaging multiple targets or signaling pathways could be advantageous for effective intervention. Combined therapy also positively impacted intraneuronal amyloid deposition at the early pre-plaque stage of the pathology and plaque pathology to a greater extent than monotherapy. Conclusions These findings further highlight the significance of multi-target therapy and support the repurposing and combination of S-adenosylmethionine and NP03 as a novel therapeutic approach for Alzheimer’s disease."

Preclinical

Impacts of novel duck reovirus infection on the composition of intestinal microbiota of Muscovy ducklings. (PubMed, Microb Pathog) - "In this study, three-day-old Muscovy ducklings were inoculated with either the virulent NDRV strain NP03 or sterile Hank's solution...Collectively, NDRV infection in Muscovy ducks resulted in a shift of the gut microbiota, including a net loss of probiotic bacteria with a compensatory expansion of pathogenic bacteria. These results provide new insights into the potential pathogenic mechanisms of NDRV."

Journal

A new treatment for Alzheimer’s (The McGill Tribune) - "A team of McGill researchers led by Dr. Claudio Cuello...Their research has shown that, in small doses, the metal lithium is capable of reducing Alzheimer’s symptoms....They administered the NP03 formula to genetically-modified rats with the amyloid precursor protein (APP) gene....Indeed, the NP03 treatments reduced levels of amyloid plaques—aggregated proteins that are thought to disrupt cell connections—and reversed memory deficits in the rats."

Preclinical

Microdose Lithium NP03 Diminishes Pre-Plaque Oxidative Damage and Neuroinflammation in a Rat Model of Alzheimer's-like Amyloidosis. (PubMed, Curr Alzheimer Res) - "These results suggest that NP03 may function to slow the AD-like pathology in part by modifying and oxidative/nitrosative damage and neuroinflammation, raising the possibility that low doses of microencapsulated lithium might be of therapeutic-preventive value during very early or preclinical AD."

Journal • Preclinical

Effective degradation of polychlorinated biphenyls by a facultative anaerobic bacterial consortium using alternating anaerobic aerobic treatments. (PubMed, Sci Total Environ) - "...NP03, Ochrobactrum sp...At the end of week 6, a yield of 17.63 ± 0.91 mg/L chloride released was measured under AN condition compared to 11.79 ± 1.28 mg/L measured under TS condition. The overall results suggested that the microbial consortia capable of degrading and utilizing PCBs under both, anaerobic and aerobic conditions achieved better PCB degradation by repeated exposure to short periods of anaerobic and aerobic conditions alternatingly rather than the conventional two stage anaerobic-aerobic conditions."

Journal