Target Product Profile for Cutaneous Leishmaniasis

A target product profile (TPP) for cutaneous leishmaniasis (CL) has been developed in consultations with cutaneous leishmaniasis experts, researchers and clinicians from both Old and New World. The TPP is being been reviewed and updated on regular bases and has been approved by the R&D team and SAC.

The main goal of the cutaneous leishmaniasis program at DNDi is to achieve short duration, safe, non-invasive, efficacious, affordable and field-friendly treatments for cutaneous leishmaniasis caused by L.tropica and L. braziliensis.

 

Attribute Ideal Acceptable
Target Species
Species dependent treatment response One treatment for All species of Leishmania L. tropica or L. braziliensis
Safety
Safety monitoring requirement
None Primary Health Care (minimal contact).
No major safety concerns.
Tolerability
Common Terminology Criteria for AE1
Well tolerated
All AR’s < grade 1
Well tolerated in >95% of patients treated.
Systemic AR > grade 2 in <5%.
Local AR ≤ grade 2 in <30%.
No treatment induced mortality.
Contraindications None Can be assessed at PHC level.
Pregnancy Safe in pregnancy and lactation Category B2
Efficacy
Complete clinical cure at 3 months from treatment onset

  • 100% epithelialization / flattening (primary outcome)
>95% patients 60% for L. tropica
70% for L. braziliensis
Improved scar formation Minimal scar No worse than natural healing
Prevention of relapse and recidivans No relapse or recidivans/ML <5% rate of relapse or recidivans/ML at 1 year
Parasitological endpoint requirement None None
Drug / Treatment schedule
Route of administration
Topical / oral Non-parenteral or few doses if parenteral
Topical
14 days 28 days
Oral < 7 days Oral: bid for 28 days
Parenteral No 3 injections
Target Population
Age No restrictions > 9 months of age
Gender No restrictions No restrictions
Use in Pregnancy Yes No
Efficacy in immuno-compromised patients Yes No
Product Characteristics
Stability No cold chain,
at least 3 years at 37ºC
2 years at 4-8ºC
Cost
Cost of products / procedures per treatment US$5 US$50

1 National Cancer Institute. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events v3.0.
2 No signs of risk in animal studies, but no adequate studies in humans.