Filaria: river blindness
Target product profile for filarial diseases
Filaria – river blindness
Target product profile for filarial diseases
Target product profile for river blindness
DNDi aims to develop a three-day oral treatment for river blindness (onchocerciasis), suitable for all ages and superior to current options, active against adult and immature worms, and safe for use in patients co-infected with Loa Loa.
| Ideal | Acceptable | |
|---|---|---|
| Formulation | Oral form | Oral form, injection, intramuscular or subcutaneous injection |
| Target population | All individuals who are at risk for onchocerciasis | All infected patients, with the exception of pregnant women and children younger than 5 years. |
| Treatment regimen | Oral dose, once a day, up to 3 days One dosage for all ages | Oral dose, once or twice a day Duration of treatment up to 14 days One single intramuscular or subcutaneous injection or repeated after a week (2 injections) One dose for adults and weight/age-adjusted or height-based dosing for children |
| Efficacy | Superior to comparator in eliminating skin microfilariae at 24 months with evidence of impacting adult worms (killing adults or embryos) | Superior to comparator in eliminating skin microfilariae at 24 months with evidence of impacting adult worms (killing adults or embryos) |
| Safety/tolerability | Adverse events • No monitoring for AE required • No impact on activities of daily living • No Mazzoti reaction • No adverse ocular reaction Population for restricted use at registration • None Precaution/Warnings • None Use in specific populations: • Safe for use in patients co-infected with L. loa • No monitoring needed (no rapid microfilariae activity) | Adverse events (AE) Minor and manageable side effects • Monitoring for AEs manageable at local healthcare post • Moderate impact on activities of daily living • No severe Mazzoti reaction • No severe adverse ocular reaction Population for restricted use at registration • Pregnant women • Lactating women (treatment duration according to pharmacokinetics of drug) Precaution/Warnings • Concomittant infections (e.g., loaiasis) • Acute illness (e.g., fever, bacterial infection) Use in specific populations: • Pre-treatment assessment and careful post-treatment follow-up should be available for patients with Loa- loa coinfection. • Exclusion of high Loa-loa mf/mL co-infected patients |
| Drug-drug interactions | • No clinically significant drug-drug interaction with commonly used anti-parasitic and anti-infective drugs. • No evidence for clinically significant, adverse interactions with long-term/chronic use drugs (e.g., anti-tuberculosis drugs, antiretrovirals, contraceptives). • No evidence for clinically significant, adverse interactions with drugs commonly administered through mass drug administration (e.g., ivermectin, praziquantel, other benzimidazoles, azithromycin), and anti-malarial drugs. | Manageable for individual case treatment |
| Stability | More than 3 years in climatic zone IVb | 3 years in climatic zone IVb |
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We develop urgently needed treatments for neglected patients and ensure they’re affordable, available, and adapted to the communities who need them
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