When administrated alone, the safety and efficacy profiles of current cutaneous leishmaniasis treatments (antimonials, miltefosine, and thermotherapy) are well established. For people with uncomplicated cutaneous leishmaniasis, where lesions are small in number and size and are not located on the face or on joints, thermotherapy – applying heat to the wound for a short duration – is the most practical and effective treatment option.

Using a combination of therapeutic approaches may improve efficacy rates, shorten treatment duration, and reduce the rate of adverse events. The Phase II study found that a combination of thermotherapy with a shorter course of oral miltefosine achieves significantly better results than thermotherapy alone. Next, a Phase III study will assess the combination treatment for non-inferiority against current recommended treatments.

Project updates

2020

Preparations for a Phase III trial at five study sites in Bolivia, Brazil, Panama, and Peru continued, although enrolment of the first patients was delayed slightly due to the COVID-19 pandemic. Patient enrolment at all five study sites is expected to begin during the first half of 2021.

2019

Preliminary results of a Phase II study completed in April 2019 show the combination of thermotherapy with a shorter course of oral miltefosine to be significantly better than thermotherapy alone for the treatment of uncomplicated cutaneous leishmaniasis in the Americas. A Phase III study is planned to start in the second half of 2020 to compare the non-inferiority of the combination against the current recommended systemic treatments, sodium stibogluconate or miltefosine.

2018

Recruitment of patients was completed in Peru (65 patients) and in Colombia (65 patients). The last patient six-month follow-up is expected in early 2019. Interim results supported the preparation of a Phase III study in the Americas comparing the combination therapy (thermotherapy and miltefosine) against the standard treatment (meglumine antimoniate) which comes with risks of potential toxicity. The study is being planned in four countries in Latin America.

2017

Recruitment of patients continued in Peru with the inclusion of 41 patients, and started in Colombia with the inclusion of 21 patients (out of 130 patients in total). An interim analysis is planned in early 2018 once 65 patients have completed the day 90 follow-up visit.

2016

At the end of 2016, official approvals were obtained, a site initiation visit conducted and the first patients were enrolled in Peru, while final approvals are expected by early 2017 for a second site in Colombia.