• DNDi logo
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Global Headquarters
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
DNDi logo
  • DNDi logo
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Global Headquarters
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > News

R&D status September 2014: DNDi Leishmaniasis programme

25 Sep 2014
Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on print

Leishmaniasis is transmitted by the bite of a sandfly. It is a complex disease with over a million new cases occurring every year and 350 million people living at risk worldwide in 98 countries. The disease presents several different forms, the most common of which are visceral leishmaniasis (VL), which is fatal without treatment, and cutaneous leishmaniasis (CL).

India, Bangladesh, Brazil, Ethiopia, South Sudan and Sudan account for 90% of all reported cases of VL. Existing treatments are either difficult to administer, toxic, or costly. Drug resistance is also an increasing problem. The WHO Roadmap (2012) has set the objective to eliminate VL from the Indian subcontinent by 2020. To contribute to the control and the elimination of the disease, DNDi’s leishmaniasis programme is working to develop new treatments by combining existing drugs and/or shortening their treatment duration, while also developing new chemical entities (NCEs).

The current leishmaniasis portfolio includes:

Research
Research

Two projects in the research phase:

  • A programme is ongoing to identify nitroimidazole backups in case VL-2098 (see projects in pre-clinical development) does not successfully complete pre-clinical testing. Over 200 analogues have been prepared so far. Two backup compounds originating from two different core structures have now been selected and are being further profiled for in vivo efficacy and safety.
  • A programme to identify oxaborole backups called Oxaleish identified oxaborole 2035804 as potential optimized lead. Further profiling is ongoing before moving into a pre-clinical programme. A number of backup compounds with similar oral efficacy have also been developed so that if the primary candidate (Oxa 2035804) fails in the safety assessment, the backup can be pursued.

Translation
Translation

Four projects in the translation phase:

  • In 2013, VL-2098 was identified among the nitroimidazoles as a very potent and safe molecule. Reproductive toxicology studies were completed with positive results. Following the completion of toxicology/safety packages as well as chemistry and manufacturing controls (CMC), VL-2098 is expected to enter into Phase I in 2015.
  • The CpG-D35 project for CL, recently  entering DNDi’s portfolio, aims at producing an immunomodulator to stimulate the innate immune system to fight the parasitic infection as an adjunct to drug therapy.
  • A Phase II proof-of-concept (PoC) study (22 patients) for VL with the NCE fexinidazole started late 2014 in Sudan
  • A Phase II study with Anfoleish, a topical cream containing amphotericin B, for CL started in 2014 at one site in Colombia. It has so far recruited 14  patients out of 80 at one site.

Development
Development

Four projects in the development phase:

  • A Phase III study of treatments for HIV/VL co-infection (132 patients), testing the combination treatment, AmBisome® and miltefosine, and monotherapy with AmBisome® at a higher dose than current practice, is being initiated in 2014 at two sites in Ethiopia
  • A Phase III study (sponsored by the Brazilian Ministry of Health) with new VL treatments based on combination therapies[1] for the treatment of VL patients in Brazil) started in 2011 at five sites and recruited 380 patients. The national guidelines for VL were revised in 2013 based on the interim safety data for AmBisome® in the trial. Glucantime® remains the first-line treatment, while Ambisome® replaced Amphotericin B deoxycholate as second-line treatment.
  • A Phase III/IV study was completed in 2013 with new VL treatments based on combination therapies (miltefosine-paromomycin, AmBisome®-miltefosine, AmBisome®-paromomycin, single dose AmBisome®) in Bangladesh. 602 patients were recruited in four sites. Results will be available later in this year.
  • A project on generic AmBisome® that aims to make a quality-assured generic Ambisome® available will start in 2014.

Implementation
Implementation

Implementation and access to treatments:

  • DNDi also continues to support the implementation of SSG&PM, a new VL treatment for Africa delivered in 2010 by DNDi and the Leishmaniasis East Africa Platform (LEAP). Whereas this new combination was recommended as first-line therapy for VL patients in East Africa by the WHO Expert Committee on the Control of Leishmaniases in 2010 and by the most affected countries, efforts are still required to ensure registration, notably of paromomycin, and treatment availability to VL patients in the region. In Asia, DNDi and partners, working closely with the Indian government, have provided data to support policy change expressed in the revised national kala-azar elimination roadmap, which recommends the use of AmBisome® single infusion and paromomycin/miltefosine combination as appropriate in low endemic districts.

For more information on the partners and donors involved in DNDi Leishmaniasis programme, please click on each hyperlink that will refer you to each project.


 [1] Amphotericin B deoxycholate, AmBisome®, and AmBisome® combined with Glucantime®, as compared to the first-line treatment, Glucantime®

By 2018, DNDi aims to deliver from its leishmaniasis-specific portfolio:

  • An oral, safe, effective, low-cost and short-course treatment
  • A new treatment for post-Kala azar dermal leishmaniasis (PKDL) that is shorter course and better tolerated than current options
  • Treatment options for HIV/VL co-infected patients
  • A safe, effective, and shorter-course treatment for CL

Read, watch, share

Loading...
Lab activities
Press releases
29 Jun 2022

DNDi welcomes new PAHO recommendations for the treatment of leishmaniasis in the Americas

Publications
16 Jun 2022

DNDi‘s Commitment to the Kigali Declaration

Caregiver prepares 4-in-1 HIV treatment for child
Press releases
14 Jun 2022

Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa

Nurse with HIV-VL patient
Publications
8 Jun 2022

The Science Explained: Evaluating new treatment regimens for visceral leishmaniasis in people living with HIV in India and Ethiopia

Doctor with a patient
Press releases
8 Jun 2022

New WHO treatment guidelines offer hope for people co-infected with visceral leishmaniasis and HIV

Doctor talking with patient during a consultation
Press releases
1 Jun 2022

Thai partners unite with DNDi to improve access to treatments and diagnostics for people with hepatitis C in Thailand

Statements
24 May 2022

DNDi interventions at the 75th World Health Assembly

Hand holding pill
Publications
23 May 2022

DNDi briefing document: Best science for all

VIEW ALL

Help neglected patients

To date, we have delivered twelve new treatments, saving millions of lives.

Our goal is to deliver 25 new treatments in our first 25 years. You can help us get there. 

GIVE NOW
DNDi logo
Facebook-f
Twitter
Instagram
Linkedin-in
Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License   
We use cookies to track our audience and improve our content. By clicking 'Accept All', you are agreeing to our use of cookies. Click on 'Customize' to accept only some cookies.
Customize
ACCEPT ALL
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
elementorneverThis cookie is used by the website's WordPress theme. It allows the website owner to implement or change the website's content in real-time.
PHPSESSIDsessionThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_ga_16Q5RH3XRG2 yearsThis cookie is installed by Google Analytics.
_gat_UA-10302561-11 minuteA variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
_hjAbsoluteSessionInProgress30 minutesHotjar sets this cookie to detect the first pageview session of a user. This is a True/False flag set by the cookie.
_hjFirstSeen30 minutesHotjar sets this cookie to identify a new user’s first session. It stores a true/false value, indicating whether it was the first time Hotjar saw this user.
_hjIncludedInPageviewSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's pageview limit.
_hjIncludedInSessionSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's daily session limit.
_hjSession_112884430 minutesNo description
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
Targeting
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
CookieDurationDescription
_hjSessionUser_11288441 yearNo description
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
SAVE & ACCEPT
Powered by CookieYes Logo