Alveron announces completion of successful Phase I clinical trial for OKL-1111

Alveron Pharma has successfully completed its first-in-human trial of OKL-1111, a new drug for the rapid treatment of intracranial haemorrhage associated with the use of anticoagulants or platelet inhibitors. 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. The company also announced a further round of investment from current shareholders, in preparation for a major Series A investment or corporate partnership. For more detail, please go to www.alveron.com

Alveron’s drug OKL-1111 is positioned as a rapid, first-line therapy for ICH

ICH is a devastating condition with a 30-50% mortality rate and is 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 - with an aging population this is a growing problem. One of the major reasons for poor outcomes in ICH is that patients are simply treated too late with reversal agents and median “door to needle” times of around 2 hours are reported. Current treatment regimen require the identity of the anticoagulant; consultation with an expert; dose calculation; patient weight and reconstitution of multiple vials of powder into solution. Combined with a CT scan this cumbersome process takes too long.

Alveron’s drug, OKL-1111, is positioned as a rapid, first-line therapy, given its universal mode of action that does not require anticoagulant or antiplatelet identification. The drug is also being developed as a ready-to-use solution for injection, reducing preparation time. Lastly, in the pre-clinical and Phase I trials there were no indications of thrombotic overshoot, reducing the need for expert risk/benefit evaluation prior to use. OKL-1111 has therefore the potential for rapid administration with greatly improved outcomes.