Financial utilization will cover the further development and immediate cash requirements. A use of financial funds are mainly required for clinical development and project management:
Concerning next steps, a rough overview of the Investigational Drug Candidate (PARICAM P-3005) can be given as follows:
1. start entrepeneurial activity / animal toxicology studies (year 1)
2. conduction clinical trial phases I / IIa until proof of concept (years 2-3)
More funds will be needed if a preparation of a clinical phase IIb & regulatory affairs (year 4 and beyond) are undertaken. This outcome then should usually be managed in cooperation of pharma industry partnering.
In comparison to more severe medical indications addressed by Antisense-Technology (e.g. Antivirals, Orphan Gene Therapies, Autoimmune Diseases), it takes substantially less time to monitor and validate clinical outcomes in oral health systems. Here, the underlying patho-mechanism of the disease is well understood, appropriate model systems for investigations in humans are available and the clinical benefit is fast and easy to monitor. Thus, the development of PARICAM P-3005 to a final market product is expected to cost substantially less than other common clinical drug developments.
until today following homeworks were performed:
i. tech-transfer for ODN production and a trustfull relationship to a preferred access to the manufacturing industry of the drug substance needed for the clinical trials,
ii. preperation of a ready to start CRO in dental research based in Germany, able to find patients and to process a clinical phase I / IIa.