Klaria's objective is to combine the Company's patented drug delivery platform with the most relevant and effective substances when it comes to pain relief and other indications where the platform is expected to enable significant advantages, such as treatment of opioid overdose and anaphylactic shock.
The development work has resulted in promising formulations and positive results in projects focusing on migraine (primarily sumatriptan), opioid overdose (naloxone), anaphylactic shock (epinephrine) and additional pain-related projects (for example cannabinoids).
The objective of the development work is to ensure bioequivalence with existing preparations and to demonstrate a lower variation in the medication's plasma profile, i.e. to show that Klaria's medication has an equivalent medical effect to existing approved preparations with less variation between patients. For each substance, this process generally comprises three stages:
- Establish a formulation by modelling both the chemical properties of the active substance, as well as how it is absorbed from the formulation in the oral mucous membrane. The aim is to run as few clinical studies as possible in order to arrive at the optimum dose in the film with the greatest potential to deliver the desired results in human trials.
- Design and implement a dosing study on a limited number of patients in clinical trials with the aim of establishing the correct dose.
- Design and implement the formal bioequivalence study in consultation with relevant authorities on a suitable number of trial subjects.
In the future, the work will include detailed studies of the molecular properties of each selected substance, both in order to ensure that they will satisfy patient needs, as well as to facilitate manufacture and distribution at competitive costs.
The priority for the various projects in the portfolio will be determined by Klaria's Board of Directors in consultation with the Company's Scientific Advisory Board.