this may be a historic moment. Since sugammadex, no new cyclodextrin has been dosed in humans as an active ingredient for a novel indication. Yesterday, Alveron Pharma finally announced that it starts the first clinical trial of a new drug for the treatment of intracranial hemorrhage.
OKL-1111, is an undisclosed new cyclodextrin 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 disabilities 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 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 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.
The drug OKL-1111 originates from a joint research project between Okklo Life Sciences and Sanquin Blood Supply Foundation.
Congratulations to Ben Nichols, Harshad (Hash) Patel, Stephan Peters, Alex Zwiers and all involved, worked and persisted in making this happen. I admire your work and cross fingers for your success in this important therapeutic target.
See the official post here: Alveron Pharma starts the first clinical trial of new drug for treatment of intracranial hemorrhage