Modus raises cash for Ph II trial of Sickle Cell drug in EU, Middle East and Caribbean

By Dani Bancroft contact

- Last updated on GMT

Modus raises more cash for Ph II trial of Sickle Cell drug

Related tags: Clinical trial

Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.

Formerly Dilaforette AB, Stockholm-based Modus was spun out from research on Sickle Cell Disease (SCD) at the Karolinksa Institutet and Uppsala University in Sweden.

In 2015, the firm also entered into a co-development partnership for its lead small molecule candidate - Sevuparin - with the UK-based contract research organisation (CRO) Ergomed plc in 2015.

Sevuparin is being developed as an anti-adhesive and anti-inflammatory small molecule to break down acute vessel blockages, known as vaso-occlusive crises (VOC), in patients with SCD.

Currently in a Phase II trial​, the drug is being administered to hospitalized SCD patients experiencing these painful crises across sites in Jamaica, Turkey, Lebanon, Bahrain, Oman, and the Netherlands.

Christina Herder, CEO of Modus Therapeutics, told us that the small molecule-based Sevuparin is manufactured from the generic blood thinner, heparin.

Novartis just acquired Selexys’ biologic for VOC in SCD patients which showed “promising data in Phase II trials.”

“Generally, a biologic is more expensive, and derivative from heparin is quite a low cost of product,” ​Herder told us.

“But we've been really encouraged by the Selexys trials, which prove there is a mechanism to treat VOC other than just pain relief,” ​she added. “Sevuparin is working in a similar way.”

Designed to enrol 150 patients in total, results for the Phase II study are expected in H1 2018.

Crude Heparin

Sevuparin is made through a chemical depolymerization of heparin, a potent blood thinner, with the aim to decrease the blood-thinning effect by removing anti-thrombin binding sites.

Herder told us the remaining anti-adhesive effect reduces microclots within the vessels and increase the “therapeutic window”.

“You start with crude pharmaceutical heparin (a generic) which you buy by the kilo and then in a relatively simple chemical process, you can synthesize Sevuparin,”​ she explained.

Modus outsources the manufacturing of Sevuparin to a single undisclosed partner, before passing on the product to their contract research organisation (CRO) and co-development partner, Ergomed plc.

Since Ergomed was originally founded in Croatia, Herder told us a majority of Modus’ interaction with the now UK-based CRO is in Zagreb too.

IV and Subcutaenous Delivery

Although Sevuaparin also has US FDA Orphan Drug Designation,Herder told us Modus is not currently conducting clinical trials with the intravenous formulation in the US.

“However, one idea is to develop a second Sevuparin product for prophylactic/earlier use instead, and not for acute treatment of VOC in hospitals.”

Although just an idea for now, Herder added this might be something Modus could conduct clinical trials on in the US in the future.

“This is because patients often wait several days before admitting themselves to the hospital, and subcutaneous injections at earlier points may stop them waiting until the pain is too bad,”​ she explained.

Anti-malarial

A second application of Sevuparin is for use as an anti-malarial drug, although Herder told us it is actually a bit of a coincidence that SCD patients experience a higher resistance to developing Malaria.

“Although Malaria also causes red blood cells to aggregate and stick, in SCD there is a different cause due to polymerisation of the haemoglobin.

With VOC in Sickle Cell you have a similar, but slightly different, mechanism.For this reason, Sevuparin acts as a general anti-adhesive for both indications,” ​she explained.

Despite this, when operating as Dilaforette AB in 2014, Modus terminated​ a trial of Sevuparin for treatment of Falciparum ​malaria.

However, Herder explained this was a problem with patient recruitment, since the study was based in Thailand where there are fewer cases of SCD: “If we go to certain sites in Africa, for example, recruitment wouldn’t be an issue. The decision to [run a trial] in Thailand was because of a research collaboration.”

(Image: P0/Pixabay)

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