Blueberry Therapeutics is a dermatology biotech company developing innovative topical drugs for a range of diseases, using a novel ‘nano-delivery’ platform. This technique significantly enhances the penetration of drugs into cells and tissues. Apconix was set the challenge to provide guidance on the most appropriate nonclinical safety studies needed to support the clinical development of Blueberry’s new treatments for fungal infection.
We worked closely with Blueberry scientists to develop an innovative strategy to support the initiation of clinical studies on their lead compound. We started by identifying the specific scientific questions that needed to be addressed and focusing on the data needed to answer them. By utilising existing information from numerous sources, we were able to build a case to present to regulatory agencies that sufficient evidence was already available to support the safe use in clinical studies.
By performing a systematic analysis of published data, we developed a clear scientific rationale to support the proposed clinical trial design, without the need for further nonclinical studies to support ‘First time in Man’ testing.
This work was discussed at a successful face-to-face meeting with European regulators resulting in approval for Blueberry to begin clinical testing of this novel therapeutic agent.
“The support that we received from the Apconix team has been excellent and they have helped us both in developing our nonclinical safety thinking and in providing direct support for the clinical trial application. We’re looking forward to continuing our collaboration as we progress our exciting new medicines into later-stage development and hopefully the clinic”