Probiodrug announces enrolment of first patient in Phase 2 Study of novel Treatment for Alzheimer’s disease

First patient enrolled at leading Alzheimer Center in Amsterdam

HALLE/SAALE, Germany, 09 March 2015 – Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer’s disease (AD), announces today that the first patient has been enrolled in the Phase 2a “SAPHIR” clinical study of its lead product PQ912 at the Alzheimer Center, VU Medical Center (VUmc), Amsterdam.

PQ912 is a novel pathology-related drug candidate with disease modifying potential for AD. It is a small molecule that targets glutaminyl cyclase (QC), an enzyme which catalyzes the formation of pyroglutamate-Abeta (pGlu-Abeta), a highly toxic Abeta variant. This modified peptide triggers the formation of toxic soluble Abeta oligomers which are a key culprit in the disease pathology. Probiodrug discovered QC and has developed QC-inhibition as a therapeutic concept for AD to the current stage. PQ912 is the first QC-inhibitor being tested in patients.

The phase 2a clinical trial ‘Safety and Tolerability of PQ912 in Subjects with Early Alzheimer’s disease (SAPHIR)’ is a randomized, double-blind multi-center study which plans to enrol a total of 110 patients with early stage Alzheimer’s disease. It will be led by internationally renowned experts in AD in five European countries at 14 sites.

The primary endpoint of the trial is the safety and tolerability of PQ912 compared with placebo over a three-month treatment period. Additionally, a set of exploratory read-outs comprising cognitive tests, functional assessments by EEG and functional MRI and new molecular biomarkers in CSF will be used to evaluate the compound’s effect on the pathology of the disease. First data of the SAPHIR study are expected mid-2016.

Professor Philip Scheltens, Director of the Alzheimer Center at VUmc and Chairman of the SAPHIR study, said: “Our team at the Alzheimer Centre is very excited and highly dedicated to carrying out this important novel trial in Alzheimer’s disease.  Its design and intervention make this trial unique, and all investigators are eager to see the outcomes.”

Inge Lues, Chief Development Officer at Probiodrug, commented: “The start of the SAPHIR study is an important milestone for Probiodrug. The design of this study results from close collaboration with Professor Scheltens and his team at the Alzheimer Centre and builds on PQ912’s strong Phase I data package. We believe PQ912 offers a promising and innovative approach to treating Alzheimer’s disease and hope to show therapeutic potential for novel QC-inhibitors in this first-in-patient clinical trial.”

The SAPHIR study follows an exploratory Phase I study in which PQ912 was proven to be safe and well tolerated and showed good pharmacokinetic profile resulting in effective brain concentration and target occupancy.

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For more information please contact:

Dr Konrad Glund, CEO, Probiodrug
Email: contact@probiodrug.de

Hume Brophy  

Mary Clark, Supriya Mathur, Hollie Vile
Email: probiodrug@humebrophy.com
Tel: +44 (203) 440 5653

Notes to Editors:

About Probiodrug AG

Headquartered in Halle, Germany, Probiodrug AG 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. www.probiodrug.de

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, over 35 million people worldwide currently live with the condition and this number is expected to double by 2030 and to more than triple by 2050 to 115 million (World Alzheimer Report 2013).

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.