A new paper on the population pharmacokinetics (PK) of our fixed-dose combination (FDC) is out. Building on data collected from children, adolescents and adults, both healthy and infected with soil-transmitted helminths (STH), a study lead by Jaime Algorta (Liconsa, part of the STOP2030 consortium) shows that the FDC dosages (400mg/9mg and 400mg/18mg of albendazole and ivermectin, respectively) are adequate and achieve similar bioavailability levels to each drug provided separately. The results are published in Clinical Pharmacology & Therapeutics, one of the top journals in its field.

Pharmacokinetics studies the interaction between the body and a substance from the moment it enters until it is eliminated. It helps determine how is it absorbed, where it goes, what organs or tissues it interacts with and how and when it is excreted. Population pharmacokinetics tries to understand how factors such as age, gender or health status affect the interaction.

“We now have a clear understanding of how the FDC behaves across a diverse range of people,” says Algorta, Research Director at Liconsa. Although previous PK studies focused on albendazole and ivermectin individually, this paper is the first to describe it for a combination of both drugs across a widespread population. Pending the publication of the results on efficacy and safety of the ALIVE phase II/III pivotal clinical trial, conducted in 2022 /2023, “the PK shows it is very similar” to providing each medicine separately, the researcher explains.

“A population PK study provides additional certainty about the effects of our fixed-dose combination in the body”, clarifies Algorta. The results will also convey important information to drug registration agencies for evaluating the merits of our FDC, which has already entered for registration at the European Medicines Agency (EMA) and Ghana’s Food and Drug Administration (FDA).

Our FDC aims to provide a drop-in replacement for the current standard used in mass drug administration (MDA) campaigns for STH. Combining a fixed dose of ivermectin with the current monotherapy of albendazole targets more parasite species and can be an important tool for achieving the control goals in WHO’s 2021-2030 Roadmap for STH. “Using ivermectin in an MDA context is hard”, explains Algorta. “It’s dosed by weight, and it’s not uncommon to end up giving up to 6 pills to many patients. It’s a lot, and reducing the number of tablets can help these campaigns be much more efficient”.

Reducing the number of tablets not only simplifies logistics, but also can help avoid dosing errors. By being orodispersable –it dissolves in contact with the patient’s saliva– our FDC also tackles another risk in MDAs: the choking hazard.

The population PK study supports the choice of two alternative dosing tablets. One, a 400mg/9mg tablet for children from 15kg to 45kg, and another 400mg/18mg tablet to anyone above that weight. “You just split the group in two and that’s it”, Algorta says.