2nd October 2023 Nijmegen, The Netherlands
Alveron Pharma announces that it has completed a Phase 1 clinical study for OKL-1111, a new drug for the rapid treatment of Intracranial Haemorrhage (ICH) and other life-threatening bleeds 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.
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.
Introduction of portable stroke diagnostics and telemedicine will herald a new era in ultra-rapid treatment
Exciting new developments in portable assays, computerized tissue temnography, and telemedicine will enable ICH to be detected in an ambulance. OKL-1111’s profile is suited to this environment and the administration of a reversal agent pre-hospital will have a dramatic impact on mortality and disability.
Alveron’s CEO, Ben Nichols commented, “This is good progress towards a treatment that could really impact outcomes for this devastating condition. With the increased use of anticoagulants and platelet inhibitors worldwide, it is a timely development.
Michel Briejer of Thuja Capital, Alveron’s lead investor, commented “With the successful completion of the Phase 1 trial for OKL-1111, Alveron Pharma is one step closer to bringing their revolutionary universal reversal agent to patients suffering from intracranial haemorrhage, one that brings the promise of swifter response and improved outcomes.”
Background Information
Alveron Pharma is based in the Netherlands and UK and is backed by venture capital managers Thuja Capital (thujacapital.com); Waterman Ventures (watermanventures.nl); Oost NL (oostnl.nl); Zwiers Pharma BV; and Sanquin Innovatie BV (sanquin.org/partnering). The company has also received an Innovation Credit loan from the Dutch government. The drug, OKL-1111, originates from a joint research project between OKKLO BV and Sanquin, the Dutch blood foundation. Alveron acquired the rights to OKL-1111 and is led by an experienced management team. For further information contact: Ben.nichols@alveron.com; michel.briejer@thujacapital.com