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Ivermectin long acting injectable - Medincell

Drug Profile

Ivermectin long acting injectable - Medincell

Alternative Names: mdc-STM; mdc-TTG

Latest Information Update: 13 Nov 2023

At a glance

  • Originator MedinCell S.A.
  • Developer MedinCell S.A.; Monash University
  • Class Antimalarials; Antineoplastics; Antiparasitics; Antivirals; Macrolides; Skin disorder therapies; Small molecules
  • Mechanism of Action Chloride channel agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II COVID 2019 infections
  • Preclinical Malaria

Most Recent Events

  • 06 Nov 2023 MedinCell plans a phase I clinical trial for Malaria in 2024
  • 28 Oct 2023 No recent reports of development identified for phase-I development in COVID-2019-infections(In volunteers) in United Kingdom (PO)
  • 05 Jan 2023 Adverse events and efficacy data from the phase-III SAIVE trial in COVID-19 infections released by MedinCell

Development Overview

Introduction

A long-acting single three month injectable ivermectin, is being developed by MedinCell S.A., for the treatment and prevention of malaria and COVID-2019 infections. The company develops long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. The BEPO® technology controls and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. A single injection of three-month active ivermectin will allow for mass adoption unlike shorter-acting treatments, mostly oral, which require numerous renewal campaigns. Clinical development for COVID-2019 infections is underway in Bulgaria and United Kingdom. Preclinical development for COVID-2019 infections is underway in Australia and for malaria is underway in France.

As at October 2023, no recent reports of development had been identified for phase-I development in COVID-2019-infections (In volunteers) in United Kingdom (PO).

Company Agreements

In March 2020, MedinCell entered into a grant agreement of up to $US6.4 million over three years with Unitaid, for formulation and preclinical activities of a three-month acting injectable ivermectin in low and middle income countries (LMICs). MedinCell will grant a non-exclusive license to the Medicines Patent Pool to ensure distribution of the final product via public sector in LMICs. Under the terms of the agreement, the Unitaid-funded Medicines Patent Pool is in charge of licensing agreements for the exploitation of patents for medicines in low and middle income countries will receive a non-exclusive license for the long acting product and will work to find appropriate commercialization partners to ensure that the ivermectin product based on MedinCell technology will be accessible where it is needed. [1]

Key Development Milestones

COVID-2019 infections

In October 2022, MedinCell completed the phase II SAIVE trial that evaluated the prophylactic efficacy of ivermectin in regular, daily, oral form to simulate the continuous release of the active ingredient by a long-acting injectable for the prevention of COVID-2019 infections (mdc-TTG-CT-002; EudraCT2021-001938-19; NCT05305560). The randomised, double-blind, placebo-controlled trial was initiated in March 2022, that enrolled 399 patients in Bulgaria. The SAIVE study follows a phase I study [see trial below] that successfully confirmed the safety of daily, oral ivermectin administration over a long period of time. In January 2023, MedinCell reported that the SAIVE trial has met its primary efficacy endpoint. The company also released efficacy and adverse events data from the trial [2] [3] [4] .

Before September 2021, MedinCell submitted clinical trial applications in multiple European countries, including France, to initiate a randomised, double-blind, placebo-controlled phase II trial to confirm the efficacy of long-acting injectable formulation of ivermectin as a prophylactic treatment of COVID-2019 infections, as a regular, daily, oral form to simulate the continuous release of the active ingredient by a long-acting injectable. The outcome of the study will guide and optimise future developments of the long-acting injectable formulation of ivermectin [5] .

In September 2020, MedinCell initiated a phase I trial to evaluate pharmacokinetics, safety, tolerability of a continuous daily dosing regimen of ivermectin in healthy volunteers, to simulate the continuous release of the active ingredient by a long acting injectable (mdc-TTG-CT-001; NCT04632706). The randomised, double blind, placebo controlled, exploratory trial will enrol approximately 24 participants in the UK. In December 2020, the company reported positive safety results from the trial [6] [7] . In April 2021, the company released updated positive safety data from the trial [8] .

In March 2021, MedinCell announced that there are no safety concern that would prevent health authorities from assessing the use of ivermectin against COVID-2019 infections as a new indication [9] .

In June 2021, MedinCell and the project consortium members, IRD, IRSS and CIRDES, successfully designed, tested, and confirmed with Unitaid the selection of the lead formulation. In the same month results from preclinical studies were released by MedinCell [10] .

Results from preclinical studies established by Monash University were released by MedinCell [11] .

Malaria

In June 2023, MedinCell plans a phase I clinical trial for Malaria in 2024 [12] [13]

Drug Properties & Chemical Synopsis

  • Route of administration PO, SC
  • Formulation Injection, unspecified
  • Class Antimalarials, Antineoplastics, Antiparasitics, Antivirals, Macrolides, Skin disorder therapies, Small molecules
  • Target Chloride channel
  • Mechanism of Action Chloride channel agonists
  • WHO ATC code

    J05A-X (Other antivirals)

    P01B (Antimalarials)

  • EPhMRA code

    J5B9 (Antivirals, others)

    P1D (Anti-Malarials)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

bacterial infections

Official Title

Azelaic acid

2

cOVID 2019 infections

Outcome Measure

Vascular endothelial growth factor A (VEGF)

ubiquitin associated and SH3 domain containing B

Tumor necrosis factor alpha (TNF-alpha)

transportin 1

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

ribosomal protein SA

Rab9 effector protein with kelch motifs

p63

Monocyte chemoattractant protein-1 (MCP-1/CCL2)

mitochondrial intermediate peptidase

MAPK1

major intrinsic protein of lens fiber

MAFIP

LANCL1

Interleukin-8 (IL-8)

Interleukin-7 (IL-7)

Interleukin-6 (IL-6)

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-2 (IL-2)

Interleukin-17 (IL-17)

Interleukin-15 (IL-15)

Interleukin-13 (IL-13)

Interleukin-12B (IL-12p40)

Interleukin-12A (IL-12p35)

Interleukin-10 (IL-10)

Interleukin-1 receptor antagonist (IL-1RA)

interleukin 1 receptor type 1

Interleukin 1 Beta (IL-1β)

Interferon Gamma (IFNg)

IFN-alpha 2

Hepatocyte growth factor

H3P28

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

G-CSF

Fibroblast Growth Factor (FGF2)

Epidermal growth factor (EGF)

CXCL9

Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10)

C-C motif chemokine 4 (CCL4

annexin A6

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

COVID-19 respiratory infection

Arm Group Description

Lactoferrin

D-dimer

Ascorbic acid

1

1

1

COVID-19 respiratory infection

Eligibility Criteria

Ferritin

C-reactive protein (CRP)

1

1

filarial elephantiasis

Eligibility Criteria

Creatinine

1

filarial elephantiasis

Outcome Measure

tubulin folding cofactor A

1

malaria

Arm Group Description

Hexakis(2-methyl-2-phenylpropyl)distannoxane

1

malaria

Outcome Measure

peptidylprolyl isomerase G

MDR1

1

1

rosacea

Official Title

Azelaic acid

2

rosacea

Outcome Measure

pregnancy specific beta-1-glycoprotein 2

CEA

carcinoembryonic antigen related cell adhesion molecule 3

1

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Ivermectin long acting injectable - Medincell 24,25-Dihydroxyvitamin D Arm Group Description
ACE2 Arm Group Label, Outcome Measure
AKT interacting protein Outcome Measure
Alkaline phosphatase (ALPL) Outcome Measure
Alpha-synuclein (aSyn) Arm Group Description
ALT Outcome Measure
annexin A6 Outcome Measure
Ascorbic acid Arm Group Description, Arm Group Label
Bilirubin Detailed Description, Eligibility Criteria
C-C motif chemokine 4 (CCL4 Outcome Measure
C-reactive protein (CRP) Detailed Description, Eligibility Criteria, Outcome Measure
CA 15-3 Detailed Description, Outcome Measure
Carbohydrate antigen 19-9 (CA 19-9) Detailed Description, Outcome Measure
Cardiac Troponin I Outcome Measure
CASR Outcome Measure
CEA Detailed Description, Outcome Measure
Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10) Outcome Measure
Cholecalciferol Arm Group Description, Brief Title, Official Title
complement factor properdin Outcome Measure
Creatine Outcome Measure
Creatinine Detailed Description, Eligibility Criteria
CXCL9 Outcome Measure
CYP3A4 Arm Group Description, Detailed Description, Outcome Measure
Cysteamine Arm Group Description, Arm Group Label
Cytidine monophosphate Detailed Description
D-dimer Arm Group Description, Brief Summary, Detailed Description, Outcome Measure
Epidermal growth factor (EGF) Outcome Measure
esterase activator Outcome Measure
Ferritin Detailed Description, Eligibility Criteria, Outcome Measure
Fibrinogen Detailed Description, Outcome Measure
Fibroblast Growth Factor (FGF2) Outcome Measure
Fluticasone Arm Group Description, Arm Group Label
fuzzy planar cell polarity protein Brief Title
G-CSF Outcome Measure
G6PD Eligibility Criteria
Granulocyte-macrophage colony-stimulating factor (GM-CSF) Outcome Measure
H3P28 Outcome Measure
Hepatocyte growth factor Outcome Measure
Hexakis(2-methyl-2-phenylpropyl)distannoxane Arm Group Description
IFN-alpha 2 Outcome Measure
Interferon Gamma (IFNg) Outcome Measure
Interleukin 1 Beta (IL-1β) Outcome Measure
interleukin 1 receptor type 1 Outcome Measure
interleukin 6 receptor Outcome Measure
Interleukin-1 receptor antagonist (IL-1RA) Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-12A (IL-12p35) Outcome Measure
Interleukin-12B (IL-12p40) Outcome Measure
Interleukin-13 (IL-13) Outcome Measure
Interleukin-15 (IL-15) Outcome Measure
Interleukin-17 (IL-17) Outcome Measure
Interleukin-2 (IL-2) Outcome Measure
Interleukin-4 (IL-4) Outcome Measure
Interleukin-5 (IL-5) Outcome Measure
Interleukin-6 (IL-6) Detailed Description, Outcome Measure
Interleukin-7 (IL-7) Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
L-Aspartic acid Outcome Measure
L-FABP Outcome Measure
Lactoferrin Arm Group Description, Detailed Description
LANCL1 Outcome Measure
MAFIP Outcome Measure
major intrinsic protein of lens fiber Outcome Measure
MAPK1 Outcome Measure
matrilin 1, cartilage matrix protein Detailed Description
MDR1 Arm Group Description, Brief Title, Eligibility Criteria, Official Title, Outcome Measure
mitochondrial intermediate peptidase Outcome Measure
Monocyte chemoattractant protein-1 (MCP-1/CCL2) Outcome Measure
p63 Outcome Measure
peptidylprolyl isomerase G Outcome Measure
PITRM1 Arm Group Description
Prothrombin (PT) Detailed Description
PTPN11 Detailed Description, Outcome Measure
purinergic receptor P2Y12 Arm Group Description
Rab9 effector protein with kelch motifs Outcome Measure
RAS Outcome Measure
Renin Arm Group Description
ribosomal protein SA Outcome Measure
seryl-tRNA synthetase Official Title
T-Cell differentiation antigen CD8 Outcome Measure
T-cell surface antigen CD4 Brief Summary, Eligibility Criteria, Outcome Measure
Thyroid stimulating hormone beta (TSH) Eligibility Criteria
Tissue factor Detailed Description
TLX1 neighbor Outcome Measure
TNFRSF1A Outcome Measure
transportin 1 Outcome Measure
Tubulin beta class IVb Outcome Measure
tubulin folding cofactor A Eligibility Criteria, Outcome Measure
Tumor necrosis factor alpha (TNF-alpha) Detailed Description, Outcome Measure
ubiquitin associated and SH3 domain containing B Outcome Measure
Uric acid Eligibility Criteria
Vascular endothelial growth factor A (VEGF) Outcome Measure
Vitamin D3 Arm Group Description, Brief Title, Official Title
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Phase II Bulgaria PO / unspecified MedinCell S.A. 28 Mar 2022
COVID 2019 infections - - Preclinical Australia SC / Injection MedinCell S.A., Monash University 06 Apr 2020
COVID 2019 infections Male In volunteers No development reported (I) United Kingdom PO / unspecified MedinCell S.A. 28 Oct 2023
Malaria - - Preclinical France unspecified / Injection MedinCell S.A. 25 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
MedinCell S.A. Originator France
MedinCell S.A. Owner France
Medicines Patent Pool Market Licensee Switzerland
UNITAID Funder Switzerland
Monash University Collaborator Australia

Scientific Summary

Adverse Events

In a phase II trial, there were no safety signals related to daily intake of ivermectin, 200 µg/kg on Day 1 then 100 µg/kg daily from Day 2 to Day 28 [2] [4] .

In a phase I trial of ivermectin, there were no side effects observed with all the three doses upto 100 µg/kg including 50mcg/kg and 75mcg/kg [8] [6] [7] .

Pharmacodynamics

Summary

Results from in-vivo proof of concept showed that injectable long-acting formulation of ivermectin demonstrated potent efficacy with a 3-month mosquitocidal effectiveness when administered to cattle [10] .

In preclinical studies, ivermectin killed coronavirus in a laboratory setting in 48 hours. Additionally, a single treatment of ivermectin also demonstrated a ~5000-fold reduction in virus at 48h in cell culture [11]

Therapeutic Trials

In a phase II trial, ivermectin showed a highly statistically significant reduction (72%) of laboratory-confirmed infections between baseline and Day 28 (30/200) versus placebo (105/199), [p<0,0001] [2] [4] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2023 Trial Update MedinCell plans a phase I clinical trial for Malaria in 2024 [13] 13 Nov 2023
31 Mar 2021 Regulatory Status MedinCell announces intention to submit marketing authorization application for ivermectin long-acting injectable by early 2021 [14] 01 Oct 2020
31 Dec 2020 Trial Update MedinCell plans to enter the preliminary preclinical stages of regulatory development by the end of 2020 [14] 01 Oct 2020

Development History

Event Date Update Type Comment
06 Nov 2023 Trial Update MedinCell plans a phase I clinical trial for Malaria in 2024 [13] Updated 13 Nov 2023
28 Oct 2023 Phase Change - No development reported No recent reports of development identified for phase-I development in COVID-2019-infections(In volunteers) in United Kingdom (PO) Updated 28 Oct 2023
05 Jan 2023 Scientific Update Adverse events and efficacy data from the phase-III SAIVE trial in COVID-19 infections released by MedinCell [2] Updated 09 Jan 2023
13 Oct 2022 Trial Update MedinCell completes the phase-II SAIVE trial in COVID-2019 infections in Bulgaria (PO) (NCT05305560) Updated 09 Jan 2023
28 Mar 2022 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Prevention) in Bulgaria (PO) [3] (NCT05305560) Updated 31 Mar 2022
21 Dec 2021 Biomarker Update Biomarkers information updated Updated 23 Dec 2021
01 Sep 2021 Regulatory Status MedinCell files Clinical Trial Applications in France and other European countries for COVID-2019 infections (Preventions) before September 2021 [5] Updated 02 Sep 2021
01 Sep 2021 Trial Update Medincell plans a phase II trial for COVID-2019 infections (Prevention) in France and Europe (SC,Controlled release) [5] Updated 02 Sep 2021
14 Jun 2021 Scientific Update Pharmacodynamics data from preclinical studies in Malaria released by MedinCell [10] Updated 21 Jun 2021
21 Apr 2021 Scientific Update Positive updated safety data from a phase I trial in COVID-2019 infections released by MedinCell [8] Updated 26 Apr 2021
22 Dec 2020 Scientific Update Adverse events data from a phase I trial in COVID-2019 infections released by MedinCell [6] Updated 22 Dec 2020
29 Sep 2020 Regulatory Status MedinCell announces intention to submit marketing authorization application for ivermectin long-acting injectable by early 2021 [14] Updated 01 Oct 2020
29 Sep 2020 Trial Update MedinCell plans to enter the preliminary preclinical stages of regulatory development by the end of 2020 [14] Updated 01 Oct 2020
22 Sep 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In volunteers) in United Kingdom (PO) (NCT04632706) Updated 25 Nov 2020
06 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in Australia (SC) [11] Updated 09 Apr 2020
06 Apr 2020 Scientific Update Pharmacodynamics data from preclinical studies in COVID-2019 infections released by MedinCell [11] Updated 09 Apr 2020
25 Mar 2020 Licensing Status MedinCell signs a grant agreement with Unitaid for injectable ivermectin for Malaria [1] Updated 01 Apr 2020
25 Mar 2020 Phase Change - Preclinical Preclinical trials in Malaria in France (unspecified route) [1] Updated 31 Mar 2020

References

  1. MedinCell Receives $ 6.4 Million Grant From Unitaid to Fight Malaria.

    Media Release
  2. MedinCell announces positive results for the SAIVE clinical study in prevention of Covid-19 infection in a contact-based population.

    Media Release
  3. MedinCell: Inclusion of First Participants in New Covid-19 Prophylaxis Clinical Trial SAIVE.

    Media Release
  4. A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19

    ctiprofile
  5. MedinCell Provides an Update on Its Product Portfolio, Following the FDA Acceptance of New Drug Application for the Product mdc-IRM.

    Media Release
  6. Covid-19: MedinCell Presents Positive First Results From the Clinical Trial Aiming at Validating the Safety of Continuous Administration of Ivermectin.

    Media Release
  7. A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Active IMP in Healthy Volunteers

    ctiprofile
  8. Clinical Trial Conducted by MedinCell Confirms the Safety of Continuous Administration of Ivermectin.

    Media Release
  9. Covid-19: MedinCell Publishes an Extensive Ivermectin Safety Expert Analysis.

    Media Release
  10. MedinCells Long-Acting Injectable to Fight Malaria Ready to Enter Regulatory Development.

    Media Release
  11. MedinCell Has Launched a COVID-19 Research Initiative Based on Its Experience to Formulate Long-Acting Injectable Ivermectin.

    Media Release
  12. MedinCell announces its full year financial results.

    Media Release
  13. MedinCell at the 2023 Jefferies Global Healthcare Conference -London, 14-16 November.

    Media Release
  14. MedinCell Initiates the First Clinical Trial of Its Covid-19 Prevention Program.

    Media Release
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