Last Patient Last Visit (LPLV) reached in the SAPHIR Study, a Phase 2 trial with the Glutaminyl Cyclase (QC) inhibitor PQ912 in early Alzheimer’s Disease (AD)
HALLE (SAALE), Germany, 07 April 2017 – Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer’s disease (AD) and other neurodegenerative disorders, announced today that the Last Patient’s Last Visit (LPLV) occurred on 05 April 2017 in the currently running Phase 2a SAPHIR study investigating the QC-inhibitor PQ912 in patients with early AD. The study randomized 120 patients in seven countries at 21 investigational sites.
Key results for the primary endpoint of safety/tolerability and for components of the three exploratory endpoints – cognition, EEG/fMRI and the main molecular biomarkers are expected to be communicated in early June 2017. Additional information resulting from further data mining including correlation analysis between elements of the safety and efficacy readouts and a set of additional exploratory biomarkers will be available later in the year.
Commenting on the announcement, Dr Inge Lues, CDO of Probiodrug said: “We are very pleased with the operational conduct of the study and that, as announced, we will meet the timelines for study completion and key data communication within Q2 of this year. It will be extremely exciting to see the results of the very innovative differentiated approach of QC inhibition, evaluated in early AD-patients applying very innovative trial design, which will provide instrumental information to further pursue the concept with our drug candidate PQ912.”
For more information, please contact:
Dr Konrad Glund, CEO
Conor Griffin, Jonothan Blackbourn, Alex Protsenko
Tel: +44 (0) 20 7862 6381
The Trout Group
Tel: +1 (646) 378-2953
MC Services AG
Anne Hennecke, Caroline Bergmann
Tel: +49 (0) 211 529 252 20
Notes to Editors:
About Probiodrug AG
Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer’s disease.
Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes – the DP4 inhibitors – which provided the basis for a novel class of antidiabetics – the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions.
Today Probiodrug’s aim is to become a leading company in the development of Alzheimer’s disease treatments and to thereby provide a better life for Alzheimer’s disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer’s disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company’s view, with a leading position in this field of research.
Probiodrug’s lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer’s animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition.
About Alzheimer’s disease
Alzheimer’s disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer’s disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer’s has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016).
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.