long-acting injectable ivermectin / MedinCell - LARVOL DELTA

Comparative susceptibility of wild and laboratory-reared Aedes and Anopheles larvae to ivermectin. (PubMed, Malar J) - "Overall, these data showed how development parameters of laboratory-raised and wild-derived Anopheles and Aedes larvae are affected differently by ivermectin, highlighting potential implications for vector control strategies and ecological concerns regarding non-target organisms and environment persistence. Further investigations are planned to understand existing mechanisms allowing wild-derived larvae to better survive than laboratory ones despite the presence of ivermectin in their breeding environment."

Journal

Does Ivermectin impair Anopheles attractiveness toward treated hosts under fields and laboratory conditions? (ASTMH 2024) - "We showed an insecticidal effect for up to 3-4 months on major wild malaria vector, meeting the WHO target product profile for endectocide-based malaria control. Dual-choice experiments with wild mosquitoes may help concluding on potential attractiveness impairment by ivermectin treatments, from which disentangling parts of the princeps molecule and the vehicle will also be needed."

Infectious Disease • Malaria

Pharmacokinetic properties and mosquito-lethal effects of a novel long-lasting formulation of ivermectin in cattle (ASTMH 2024) - "Body weight-scaled doses used in cattle (0.6, 1, 1.5 mg/kg) were predicted to result in sustained ivermectin exposure and sustained dirus and minimus killing for >35 days and >90 days, respectively, after a single injection. This could be a promising novel tool for transmission blocking of malaria and for the treatment of NTDs in humans."

PK/PD data • Infectious Disease • Malaria

Long-acting formulation of Ivermectin for effective malaria control: insights from an age-structured modelling study. (ASTMH 2024) - "Translated to entomological parameters, this corresponds to a 65% decrease of infectious Anopheles’ population. Using our model, we therefore demonstrated that MDA using our candidate LAIF would meet the WHO requirements of more than 20% decrease of clinical case prevalence for novel malaria vector control tools."

Infectious Disease • Malaria

Comparative susceptibility of wild-derived and laboratory-reared Aedes and Anopheles larvae to Ivermectin: a preliminary study toward experimental selection of larval ivermectin resistance mechanisms (ASTMH 2024) - "Overall, these data showed how lab-raised and wild-derived Anopheles and Aedes larvae and females are affected differently by ivermectin, highlighting potential implications for vector control strategies. Further investigations are planned to understand potential existing mechanisms allowing wild-derived larvae to better survive than laboratory ones despite the presence of ivermectin in their breeding environment."

Wide and sustained long-term target efficacy of an injectable long-acting ivermectin formulation againstPlasmodiumvectors in the fight against malaria (ASTMH 2023) - "Dose-response models will compare susceptibility between species and resistance backgrounds, and help to understand metabolite effects. Our results will provide crucial data on this innovative LAIF with promising epidemiological relevance towards a phase-1 trial in humans."

Clinical • Infectious Disease • Malaria

Evaluation of the systemic insecticidal effects of ivermectin treated cattle on Aedes aegypti, vector of arboviruses (ASTMH 2023) - "Hence, Ivermectin could contribute to significantly reduce Ae. aegypti populations densities if the toxic effect is sustained over time, notably through the use of Long Acting Ivermectin Formulations."

Long-acting formulation of Ivermectin for effective malaria control: insights from an age-structured modelling study (ASTMH 2023) - "Several studies have modelled the impact of mass drug administration (MDA) of oral ivermectin to human populations and have evidenced a promising effect in reducing malaria clinical cases. The long-lasting insecticide treated net coverage associated to different malaria transmission profiles were used as baselines to evaluate the added value of using LAIF-I in realistic life conditions. The detailed effect of the LAIF-I on the reduction of malaria prevalence will be presented during the conference."

Infectious Disease • Malaria

The SAIVE trial: post-exposure use of ivermectin in COVID-19 prevention, efficacy and safety results (ECCMID 2023) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease

Proof-of-concept study for a long-acting formulation of ivermectin injected in cattle as a complementary malaria vector control tool. (PubMed, Parasit Vectors) - "This long-lasting formulation of ivermectin injected in cattle could complement insecticide-treated nets by suppressing field populations of zoophagic mosquitoes that are responsible, at least in part, for residual malaria transmission. The impact of this approach will of course depend on the field epidemiological context. Complementary studies will be necessary to characterize ivermectin withdrawal times and potential environmental toxicity."

Journal • Infectious Disease • Malaria

SAIVE: A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (clinicaltrials.gov) - P2 | N=400 | Completed | Sponsor: MedinCell S.A | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Drug repurposing for optimal use of Ivermectin against malaria: long lasting formulations allowing efficacy against wild-derived Anopheles for at least 2 months (ASTMH 2022) - "Discrepancies between both colonies pointed possible cross-resistance mechanisms displayed by field Anopheles. Further modeling at the epidemiological level and safety studies are ongoing towards human application in the future."

Clinical • Infectious Disease • Malaria

Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: MedinCell S.A; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • PCR

Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: MedinCell S.A

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • PCR

MedinCell begins first Covid-19 clinical study with Ivermectin (Pharmaceutical Business Review (PBR)) - "French clinical-stage pharmaceutical firm MedinCell has commenced the first clinical trial of its Covid-19 prevention programme. The randomised, double-blind, exploratory phase I trial A has been designed to evaluate the pharmacokinetic profile, safety and tolerability of a continuous daily dosing regimen of Ivermectin in healthy volunteers....The current clinical study will enable to validate Ivermectin safety when taken regularly in oral form over four weeks to simulate the continuous release of the active ingredient by a long-acting injectable....Based on the positive results, the company intends to apply for market authorisation by the end of 2021."

Regulatory • Trial status • Infectious Disease • Novel Coronavirus Disease