Auxesis Pharma Receives Ethical Approval for Planned Clinical Study with ASA.P®
AUXESIS PHARMA HOLDING AB (publ) today announced that it has received ethical approval from the Swedish Ethical Review Authority for the company’s planned clinical study with its drug candidate ASA.P®.
The authority concluded that the proposed study is ethically acceptable and complies with the requirements for protecting the safety, integrity, and rights of study participants. The approval confirms that the study design is ethically justified and that the research has a legitimate medical purpose. The company is currently planning to initiate the clinical study during the second quarter (Q2).
Next step: regulatory review
Before the clinical study can commence, approval is also required from the Swedish Medical Products Agency, which will evaluate the drug candidate’s quality, safety, and the scientific study design. Approval from both authorities is required before the study can be initiated.
Important milestone
The ethical approval represents an important milestone in the development of ASA.P®, which aims to provide new treatment options for local pain management in the skin. Auxesis Pharma will now continue the regulatory process in preparation for the next stage of its development program.