A solution to haemorrhagic stroke or intracranial haemorrhage (ICH), a severe unmet medical need
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, in which pharmacists expressed concern over the delay in treating patients with life threatening bleeds.
OKL-1111 strongly reduces hematoma expansion in a mouse model of intracranial haemorrhage in mice treated with high dose warfarin (INR>8)
4 hours after induction of bleeding
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vehicle
warfarin
20 mg/kg
30 mg/kg
40 mg/kg
OKL-1111
24 hours after induction of bleeding
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warfarin
20 mg/kg
30 mg/kg
40 mg/kg
OKL-1111
Alveron’s drug OKL-1111 is positioned as a rapid, first line therapy as it has a truly universal mode of action, not requiring anticoagulant or platelet inhibitor identification. OKL-1111 is being developed as a ready-to-use solution for injection eliminating a very time consuming preparation step. The pre-clinical safety data also indicates a very low risk of thrombotic overshoot, reducing the need for expert risk : benefit evaluation prior to use. In the longer term, OKL-1111 has a profile suitable for use in ambulances and the company is exploring mobile scanning technologies that would facilitate this early intervention.
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.
