Alveron Pharma completes successful first-in-human trial of OKL-1111

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

Alveron Pharma starts the first clinical trial of new drug for treatment of intracranial haemorrhage

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.

For further information contact:

Ben.nichols@alveron.com

michel.briejer@thujacapital.com

Alveron Pharma BV raises a further EUR 3.9 million to progress first in class drug

Alveron Pharma BV (Nijmegen, The Netherlands) has raised a further EUR 3.9 million to fund the continued development of OKL-1111, a first-in-class drug to treat anticoagulant related bleeds. Investors Thuja Capital, Waterman Ventures and Oost NL participated in the fund raising alongside a loan from Rijksdienst Voor Ondernemend Nederland (RVO). The round follows seed financing of EUR 6.5 million in 2019.

The additional funding will finance the OKL-1111 program including a first in man study which is anticipated to start in Q3 2022.

Alveron’s drug is unique as it reverses the effects of all the major anticoagulants (including all DOACs and vitamin K antagonists) and platelet aggregation inhibitors like clopidogrel. This enables clinicians to intervene in emergencies without prior knowledge of the type of anticoagulant used and potentially simplifies treatment protocols. The drug, in contrast to leading competitors, is not a biologic nor a blood derived material, providing both cost and safety advantages.

Alveron’s CEO, Dr Ben Nichols, commented “anticoagulant-related bleeding is a significant issue and poorly served by either selective reversal agents or off label use of blood derived products; with 2-3% of all anti-coagulated patients suffering bleeding events, some of which are life threatening, this is an area that needs better therapies”.

For further information contact CEO Ben Nichols (ben.nichols@alveron.com)