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

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)

Alveron Pharma closes series A round to advance a cyclodextrin based procoagulant medicine in clinic

Alveron Pharma, a newly incorporated company established by Okklo Life Sciences BV and

Sanquinnovate (part of Sanquin), is pleased to announce the closing of a EUR 6.5M Series A financing round led by Thuja together with Waterman Ventures and Oost NL. This investment allows Alveron Pharma to select a lead compound, conduct non-clinical studies, and complete a first clinical study to demonstrate safety and obtain a first clinical readout.

Alveron Pharma will focus on a unique class of cyclodextrin-based drugs, that have the ability to promote blood coagulation without inducing it in the absence of bleeding. Alveron’s first target is to reverse the effects of anticoagulants. Anticoagulants (“blood thinners”) are widely prescribed to patients with increased thromboembolic risk. While effective in preventing thrombosis, these drugs also inhibit blood coagulation when this is needed urgently, e.g. in patients who suffer a major bleed or in case of emergency surgery. Anticoagulant related bleedings are not uncommon, and may be serious, and difficult to treat since no or only selective reversal agents are available. Alveron’s cyclodextrins are unique in the sense that they restore coagulation independent of the type of anticoagulant used. Sales of selective reversal agents have been estimated at around $2 billion per annum.

Ben Nichols, CEO of Alveron Pharma: “There is a clear unmet clinical need for a universal anticoagulant reversal agent, and the early pre-clinical data for Alveron’s unique cyclodextrin compounds are compelling. Having recently taken a new class of coagulant into clinical trials, I am thrilled to be joining the founders of this business, Stephan Peters (who conceived the original idea, CSO) and Alex Zwiers (COO), with their expertise on cyclodextrins, and coagulation expert at Sanquin, Joost Meijers (Chairman of the Scientific Advisory Board). Alex was also involved in the development of the world’s first cyclodextrin-based medicine, Bridion®.”

“Multiple factors come together in this investment that are highly attractive”, says Michel

Briejer of Thuja, who led this transaction. “A highly experienced and knowledgeable team, a promising set of drug leads, and a reputable partner in the field of blood, Sanquin. We are extremely pleased to be part of this venture and are confident that Alveron will create success for doctors and patients alike.”