• DNDi - Best Science for the Most Neglected 20 Years
  • 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 and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • 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 - Best Science for the Most Neglected 20 Years
  • DNDi - Best Science for the Most Neglected 20 Years
  • 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 and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • 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 February 2017: DNDi Sleeping sickness programme

Home > News

R&D Status February 2017: DNDi Sleeping sickness programme

15 Feb 2017
Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on print

DNDi aims to deliver:

  • A safe, effective, and orally administered drug to replace current first-line HAT treatments, and to improve and simplify current case management.
  • The ideal goal is to develop two drugs that are effective against both stage 1 and 2 of HAT and both subspecies of the parasite (Trypanosoma brucei gambiense (g-HAT) and Trypanosoma brucei rhodesiense (r-HAT).
  • If successful, this would represent a fundamental shift in disease management, as it would remove the need both for a risky and painful lumbar puncture test to confirm the disease stage, and for hospitalization as treatment would no longer rely on administering a drug intravenously.

DNDi’s current HAT portfolio includes:

 

Research

Research

One project in the research phase:

 

  • SCYX-1330682 and SCYX-1608210 oxaboroles: These two back-up candidates from the oxaborole class have demonstrated cure for stage 2 of the disease in the mouse model. Given the current success of other projects for HAT, further development was put on hold in 2013, and will only recommence should problems be encountered with SCYX-7158 in clinical development.

 

Translation

Translation

One project in the translation phase:

 

  • SCYX-7158 oxaborole: Phase I trials on this new chemical entity were completed in 2015, and allowed the therapeutic dose to be determined at 960mg, administered as a single dose of three tablets. A pivotal Phase II/III trial started in the last quarter of 2016. Seven study sites – Katanda, Isangi, Dipumba, Ngandajika, Masi Manimba, Kwamouth, and Bolobo – were initiated in Democratic Republic of Congo (DRC). Eleven patients (out of a target 350) had been recruited by the end of 2016.

DevelopmentDevelopment

One project in the development phase:

 

  • Fexinidazole: In 2015, DNDi and the National HAT Control Programme (PNLTHA) of the DRC completed the recruitment of 394 adult patients with stage 2 HAT at ten clinical sites in the DRC and one (supported by MSF) in the Central African Republic, for the pivotal Phase II/III study which assesses the efficacy and safety of fexinidazole in comparison with nifurtimox-eflornithine combination therapy (NECT) in HAT stage 2 patients.

Two additional complementary cohorts with fexinidazole were also completed in 2016, one including 230 adult patients with stage 1 and early stage 2 of the disease, and another including 125 children between six and 14 years, both in DRC sites. Follow up of patients will be completed in 2017.

A Phase IIIb study aimed at getting more information about special population groups not included in previous fexinidazole trials (pregnant or lactating women, and patients with poor nutritional status or with chronic diseases) started in 2016. Patients will be treated either in hospital, or at home, thereby also providing preliminary information about the treatment compliance and final effectiveness in ambulatory patients. Three sites were initiated (Bandudu, Mushie and Bagata) and six patients (out of a target of 174) had been recruited by the end of 2016.

The submission of a regulatory dossier to the European Medicines Agency under Article 58 is planned for the late 2017, for the treatment of g-HAT with fexinidazole. It aims to facilitate faster WHO prequalification of the medicine as well as regulatory approvals and implementation in endemic countries. A risk management plan to further monitor safety and efficacy in the field is under preparation in collaboration with Sanofi and WHO.

In addition, the protocol for a study to be undertaken in r-HAT patients is being finalized, sites in Uganda and Malawi have been identified, and the study is planned to start in 2017.

 

Implementation

Implementation

Implementation and Access:

 

  • NECT: Nifurtimox-Eflornithine Combination Therapy was included on the WHO Essential Medicines List in 2009, and extended to the List for children in 2013. With the recommendation of NECT as a first-line treatment in all endemic countries, all receive free supplies from WHO via drug donations by Sanofi and Bayer, 100% of HAT stage 2 patients are now treated with NECT.
 
 
 
 

Photo credit: Simon Tshiamala-DNDi

Sleeping sickness

Read, watch, share

Loading...
Patient with healthcare worker in hospital
Press releases
30 Mar 2023

Eumycetoma: DNDi welcomes Japan’s GHIT Fund support for registration of new treatment for deeply neglected fungal disease

Davide Paparo and Ian Hausler with their thermotherapy device "CLARA"
Stories
16 Mar 2023

Cutaneous leishmaniasis: Swiss students develop innovative thermotherapy device for safer treatment of ‘flesh-eating parasite’

Stories
8 Mar 2023

Highlighting gender-based treatment gaps on International Women’s Day: Mary Alamak’s story

DNDi-GARDP Southern Africa director, Carol Ruffell (left), presents the December 2022 edition of HIV Nursing Matters and the 2022 paediatric ARV dosing chart to Bénédicte Schutz, Monaco’s Director of International Cooperation (centre), and Yordanos Pasquier, Monaco’s Deputy Director of International Cooperation (right).
News
3 Mar 2023

Working together to ensure optimal treatment for children living with HIV in South Africa

Nurse with patient
Press releases
1 Mar 2023

Fiocruz and DNDi sign strategic alliance agreement

Statements
28 Feb 2023

DNDi’s submission to the Technical Assessment component of the first Global Stocktake

Statements
22 Feb 2023

DNDi comments on the zero draft of the WHO CA+ for consideration of the Intergovernmental Negotiating Body at INB4 & 5

Hat Platform Newsletter N°22 screenshot
Publications
22 Feb 2023

HAT Platform Newsletter No. 22

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 - Best Science for the Most Neglected 20 Years
Facebook-f
Twitter
Instagram
Linkedin-in
Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical 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
REJECT 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.
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.
CookieDurationDescription
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.
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 minutesHotjar sets this cookie.
_hjSessionUser_11288441 yearHotjar sets this cookie.
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.
SAVE & ACCEPT
Powered by CookieYes Logo