OKL-1111: a solution to haemorrhagic stroke

Haemorrhagic stroke or intracranial haemorrhage (ICH) ?is a devastating condition with a 30-50% mortality rate. ICH is also responsible for approximately 50% of disability associated with stroke as a whole. The use of anticoagulants or platelet inhibitors greatly increases the probability and severity of ICH.?

There are two main reasons for the delay in treatment: Firstly, patients need to be transferred to hospital for a CT scan to determine whether they have an ischaemic or haemorrhagic stroke, before they can be treated. Secondly, current mainstream treatments require identification of the anticoagulant or platelet inhibitor used; an expert may have to be consulted for a risk/benefit assessment; ?patient weight & dose calculation; ?reconstitution of multiple vials of powder (in some cases nine vials). This process can take over one hour according to primary market research conducted on behalf of Alveron Pharma , in which pharmacists expressed concern over the delay in treating patients with life threatening bleeds.?

OKL-1111

In addition to these benefits OKL-1111 is synthetic, whereas mainstream treatments are either blood derived or expensive biologics. Lastly we have also shown efficacy against a platelet inhibitor for which there is no current antidote.

The universal action of OKL-1111 has been demonstrated in a standardised rat bleeding model for warfarin, rivaroxaban, apixaban, edoxaban, enoxaparin, fondaparinux and clopidogrel.?

Clinical trial

Alveron Pharma has completed a Phase 1 clinical study for OKL-1111. The study was conducted at Hammersmith Medicines Research in London. OKL-1111 was well-tolerated in the trial with healthy human volunteers and showed no more adverse events above those in the placebo groups. Volunteers also received an anticoagulant and a pharmacodynamic effect was observed with OKL-1111 administration. In the prior non-clinical program, the drug reduced bleeding in a clinically relevant intracranial haemorrhage model using high doses of an anticoagulant. Furthermore, a broad-spectrum mode of action was demonstrated against all classes of anticoagulant and one platelet inhibitor to date in a standard haemostasis model.

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