CorA - Dirofilaria immitis Study (Markterkundung)

The University Hospital Bonn aims to progress with the identification of additional indications for the natural product Corallopyronin A (CorA). For this, the University Hospital Bonn is looking for a contract research organization (CRO) to conduct an in vivo efficacy study in dogs infected with Dirofilaria immitis (dog heartworm). The maximum treatment time will be 28 days. To demonstrate activity of CorA against the adult worms of D. immitis, treatment will commence 210 days post infection. Necropsies are to be performed 3 months after the treatment end and recovered adult worms will be used for parasitological assessment. The study will consist of four treatment arms with n=4 for each arm: a vehicle control group, two different concentrations of CorA and doxycycline as a positive control. The entire process will be awarded to the CRO as a single-phase contract. A Master Service Agreement (MSA) or framework agreement is preferred to facilitate the commission of the required work packages in form of Statements of Work (SoWs). There will be a commercial agreement and an additional quality assurance agreement. The following services are expected from the service provider and need to be considered in the proposal: In vivo study - Study design o 4 treatment arms starting 210 days post infection (n=4): - Vehicle control ? oral administration, twice daily for 14 days - CorA (low dose) ?oral administration, twice daily for 14 days - CorA (high dose) ? oral administration, twice daily for 14 days - Doxycycline (positive control) ? oral administration, twice daily for 28 days - Infection of dogs with D. immitis - Maintenance of infected dogs according to applicable ethical guidelines and regulatory requirements - Storage of test compounds (CorA, doxycycline) at -20 or -80°C for the duration of the treatment - Oral treatment with test compounds or vehicle control for a maximum of 14 days (CorA) or 28 days (doxycycline) twice per day - Blood collection and determination of microfilarial levels every two weeks starting 180 days post infection - Blood collection (8 times) on the first and last days of treatment following the first administration of the test compound (CorA) to isolate plasma for pharmacokinetic analysis - Storage and shipment of plasma samples to Bonn, Germany - Isolation of adult worms post mortem - Parasitological assessment of adult worms (number, sex, embryograms) - Storage and shipment of adult worms to Bonn, Germany for PCR analysis Project management - Main point of contact - Scheduling and communication - Ensuring project delivery to time and budget - Managing subcontractors if necessary In addition, the following technical merits are required and are a key concern of the client: - Housing and maintenance of infected dogs according to relevant ethical guidelines and applicable local regulatory requirements - The service provider must have appropriate experience with the required treatment and analyses of samples - The service provider must prepare appropriate facilities for the storage of the test compound (CorA) at -20 or -80°C for the duration of the treatment The entire process will be awarded to the CRO as a single-phase contract. A Master Service Agreement (MSA) or framework agreement is preferred to facilitate the commission of the required work packages in form of Statements of Work (SoWs). There will be a commercial agreement and an additional quality assurance agreement.