A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.

Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.

Start Date23 Nov 2023

Sponsor / Collaborator

Medicines Development for Global Health Ltd

NCT03876262

/ Active, not recruitingPhase 3IIT

A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis

The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness.
Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.

Start Date03 May 2021

Sponsor / Collaborator

Medicines Development for Global Health Ltd

NCT04311671

/ CompletedPhase 3IIT

A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.

Start Date03 May 2021

Sponsor / Collaborator

Medicines Development for Global Health Ltd

100 Clinical Results associated with Medicines Development for Global Health Ltd

0 Patents (Medical) associated with Medicines Development for Global Health Ltd

Literatures (Medical) associated with Medicines Development for Global Health Ltd

01 May 2025·International Journal of Hygiene and Environmental Health

Environmental surveillance for Salmonella Typhi to detect the typhoid burden in Yogyakarta, Indonesia

Article

Author: Watts, Emma ; Bines, Julie E ; Dinari, Rizka ; Handley, Amanda ; Thobari, Jarir At ; McCarthy, David T ; Laksono, Ida Safitri ; Donato, Celeste M ; Supriyati, Endah ; Oktaria, Vicka ; Sari, Hendri Marinda ; Murni, Indah Kartika ; Nuryastuti, Titik

BACKGROUNDIn low and middle-income countries (LMICs), understanding the burden of typhoid disease has been challenging as clinical surveillance based on blood culture data alone often poorly represents the community burden. Underreported cases, unclear case definitions, the presence of a chronic carrier state and emerging antimicrobial resistance necessitate alternative approaches to assess disease prevalence and target public health interventions, such as vaccine introduction. This study aimed to assess the feasibility of wastewater and environmental surveillance (WES) in measuring the prevalence of typhoid infection in Indonesia.METHODSBetween October 11, 2022, and August 31, 2023, WES was conducted in 18 locations across 3 districts in Yogyakarta province, Indonesia. Samples were collected fortnightly from wastewater treatment plants (WWTPs), manholes, a river, and public spaces, using grab and passive sampling methods. Salmonella Typhi (S. Typhi) detection was conducted using quantitative PCR for S. Typhi genes (ttr, tviB, and staG - all positive).RESULTSOf the 406 samples collected, 13 % (51/406) tested positive for S. Typhi, with monthly positivity rates ranging from 2 % (1/51) in March 2023 to 47 % (16/34) in October 2022. Mean concentrations (in log10) in ttr, tviB, and staG in grab samples were 0.67 (SD ± 0.99), 0.23 (SD ± 1.14), and -0.11 (SD ± 1.05). The highest detection rates were observed in samples from the river compared to central WWTPs (OR 12.68; 95 % CI 2.03-79.20, P = 0.007). No correlation was observed between rainfall and S. Typhi gene detection (P > 0.05 for all genes).CONCLUSIONWES is feasible in Indonesia and can be used to monitor typhoid disease burden in an endemic region. High positivity rates from the river and septic tanks in traditional markets support a broad approach to sampling in LMICs where formal wastewater management systems may not accurately represent community disease prevalence due to its low population coverage. WES can be a valuable tool to inform public health responses, including vaccine introduction.

25 Apr 2024·Clinical Infectious Diseases

An Updated Economic Assessment of Moxidectin Treatment Strategies for Onchocerciasis Elimination

Article

Author: Turner, Hugo C ; Roth, Barbara ; Kura, Klodeta ; Kuesel, Annette C ; Basáñez, Maria-Gloria ; Kinrade, Sally

AbstractBackgroundConcerns that annual mass administration of ivermectin, the predominant strategy for onchocerciasis control and elimination, may not lead to elimination of parasite transmission (EoT) in all endemic areas have increased interest in alternative treatment strategies. One such strategy is moxidectin. We performed an updated economic assessment of moxidectin- relative to ivermectin-based strategies.MethodsWe investigated annual and biannual community-directed treatment with ivermectin (aCDTI, bCDTI) and moxidectin (aCDTM, bCDTM) with minimal or enhanced coverage (65% or 80% of total population taking the drug, respectively) in intervention-naive areas with 30%, 50%, or 70% microfilarial baseline prevalence (representative of hypo-, meso-, and hyperendemic areas). We compared programmatic delivery costs for the number of treatments achieving 90% probability of EoT (EoT90), calculated with the individual-based stochastic transmission model EPIONCHO-IBM. We used the costs for 40 years of program delivery when EoT90 was not reached earlier. The delivery costs do not include drug costs.ResultsaCDTM and bCDTM achieved EoT90 with lower programmatic delivery costs than aCDTI with 1 exception: aCDTM with minimal coverage did not achieve EoT90 in hyperendemic areas within 40 years. With minimal coverage, bCDTI delivery costs as much or more than aCDTM and bCDTM. With enhanced coverage, programmatic delivery costs for aCDTM and bCDTM were lower than for aCDTI and bCDTI.ConclusionsMoxidectin-based strategies could accelerate progress toward EoT and reduce programmatic delivery costs compared with ivermectin-based strategies. The costs of moxidectin to national programs are needed to quantify whether delivery cost reductions will translate into overall program cost reduction.

12 Apr 2024·The Journal of Infectious Diseases

Vaccine Take of RV3-BB Rotavirus Vaccine Observed in Indonesian Infants Regardless of HBGA Status

Article

Author: At Thobari, Jarir ; Satria, Cahya Dewi ; Lyons, Eleanor A ; Nirwati, Hera ; Donato, Celeste M ; Byars, Sean G ; Handley, Amanda ; Pavlic, Daniel ; Soenarto, Yati ; Bogdanovic-Sakran, Nada ; Ong, Darren S ; Watts, Emma ; Bines, Julie E

AbstractBackgroundHisto-blood group antigen (HBGA) status may affect vaccine efficacy due to rotavirus strains binding to HBGAs in a P genotype–dependent manner. This study aimed to determine if HBGA status affected vaccine take of the G3P[6] neonatal vaccine RV3-BB.MethodsDNA was extracted from stool samples collected in a subset (n = 164) of the RV3-BB phase IIb trial in Indonesian infants. FUT2 and FUT3 genes were amplified and sequenced, with any single-nucleotide polymorphisms analyzed to infer Lewis and secretor status. Measures of positive cumulative vaccine take were defined as serum immune response (immunoglobulin A or serum-neutralizing antibody) and/or stool excretion of RV3-BB virus. Participants were stratified by HBGA status and measures of vaccine take.ResultsIn 147 of 164 participants, Lewis and secretor phenotype were determined. Positive vaccine take was recorded for 144 (97.9%) of 147 participants with the combined phenotype determined. Cumulative vaccine take was not significantly associated with secretor status (relative risk, 1.00 [95% CI, .94–1.06]; P = .97) or Lewis phenotype (relative risk, 1.03 [95% CI, .94–1.14]; P = .33), nor was a difference observed when analyzed by each component of vaccine take.ConclusionsThe RV3-BB vaccine produced positive cumulative vaccine take, irrespective of HBGA status in Indonesian infants.

100 Deals associated with Medicines Development for Global Health Ltd

100 Translational Medicine associated with Medicines Development for Global Health Ltd

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Moxidectin ( GluCls )	Onchocerciasis More	Approved
Dovramilast ( PDE4 )	Tuberculosis More	Phase 2

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