Lead compound PQ912 - a first-in-class highly specific and potent Glutaminyl Cyclase (QC) inhibitor
Probiodrug presented the detailed study design of the Phase 2b core program for its QC inhibitor which incorporated the newest FDA and EMA draft guidance for early AD trials. The Phase 2b core program will consist of two clinical trials in the EU and USA. The first Phase 2b study will investigate the safety and efficacy of the optimal dose range of PQ912 in early AD patients. This trial will build on the excellent and efficient infrastructure established by the Phase 2a SAPHIR study.
PBD-C06 - a monoclonal antibody selectively targeting pGlu-Abeta
PBD-C06 is currently in the preclinical stage. The antibody has been successfully humanized and also de-immunized to avoid detection by the patient's endogenous immune system. For the first time in an anti-pGlu-Abeta approach, PBD-C06 has not only shown the ability to reduce Abeta/plaques but also to significantly improve cognitive deficits in aged Alzheimer's mice. Moreover, no evidence was found for increased microhemorrhages after treatment with PBD-C06.
Dr. Michael Schaeffer was appointed to the position of Executive Vice President of Business and Strategy, effective August 2018. Dr. Schaeffer brings more than 15 years of experience across pharma and biotech in strategic business development, scientific project and alliance management to Probiodrug.
POST PERIOD HIGHLIGHTS
Probiodrug announced the appointment of Dr. Michael Schaeffer to Chief Business Officer, effective October 1, 2018. Drawing on his extensive experience in neurology projects across all stages of development, Dr. Schaeffer has additionally taken over Probiodrug's R&D division. Dr. Inge Lues' term as Chief Development Officer came to an end effective October 31, 2018, with the contractual termination of her current agreement.
Extraordinary General Meeting of Shareholders 2018
On December 7, 2018, Probiodrug will held an Extraordinary General Meeting of Shareholders. The single item on the agenda: Report of a loss amounting to half the share capital pursuant to Sec. 92 pa-ra. 1 AktG.
The mid-term focus of Probiodrug's business activities remain unchanged and can be summarized as follows:
Execution of the Phase 2b clinical study program for PQ912
Identifying industrial partners
Further strengthening Probiodrug's financial basis
The company's current financial resources are expected to be sufficient to fund operations until the end of Q3/2019.