20th March 2023 Nijmegen, The Netherlands
Alveron Pharma announces that it has commenced a Phase 1 clinical study for OKL-1111, a new drug for the treatment of Intracranial Haemorrhage (ICH) and other life-threatening bleeds associated with the use of anticoagulants or platelet inhibitors. The clinical trial is taking place in the UK and will investigate safety, pharmacokinetics and pharmacodynamics in man.
ICH is a devastating condition with a 30-50% mortality rate and 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, and 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. Current mainstream therapies require the identity of the anticoagulant; consultation with an expert; dose calculations with some requiring patient weight and reconstitution of multiple vials of powder into solution. This process can take over one hour.
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 identification. OKL-1111 is being developed as a ready-to-use solution for injection also eliminating a very time-consuming preparation step. The pre-clinical safety data indicates a very low risk 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.
OKL-1111’s product profile is also potentially suitable for use in ambulances which may become feasible with the introduction of mobile diagnostic technologies. This would further reduce the time to treatment, radically improving outcomes.
Alveron’s CEO, Ben Nichols commented “this is the first step towards a treatment that could really impact on outcomes for this devastating condition and with the increased use of anticoagulants and platelet inhibitors worldwide, it is timely”.
Michel Briejer of Thuja Capital, Alveron’s lead investor, commented “it is exciting to see this drug now move into clinical testing, after having generated an extensive preclinical data package suggestive of good safety and universal reversal of anticoagulants”.
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 IK 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.
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