HALLE/SAALE, Germany, 13 May 2015 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), today announces its first quarter business update for the period ended 31 March 2015, in the form of an interim management report.
The interim management report including the first quarter 2015 business update is available for download on the company website (http://www.probiodrug.de/investors/reports-and-presentations/).
Operational Highlights
Commenting on the first quarter, Dr Konrad Glund, Chief Executive Officer of Probiodrug said:
"We have had a promising start to 2015. The start of the Phase 2a "SAPHIR" clinical study of our lead product candidate PQ912 is a significant achievement for the company. We strengthened our IP position in Japan with the grant of new patents. We also announced progress with our anti-pGlu-3 Abeta monoclonal antibody as well as further scientific insight on the role of Glutaminyl Cyclase (QC) and pGlu-Abeta in the pathology of AD.
"Furthermore, the beginning of 2015 has been significant for the Alzheimer's field as a whole. Biogen reported early clinical data on its general Abeta Antibody showing slowing of disease progression, clearly supporting the concept of Abeta being key in the AD-pathology and encourages us to pursue our differentiated, toxicity focused approach."
OPERATIONAL UPDATE
Pipeline update
The development approaches of Probiodrug are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. This modified Abeta is considered to be linked with disease initiation and progression by seeding the formation of soluble neurotoxic amyloid oligomers. Probiodrug is developing proprietary product candidates to target toxic pGlu-Abeta via two modes of action: by (i) inhibiting the production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta from the brain.
Probiodrug's innovative approaches comprise the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is instrumental in the creation of pGlu-Abeta. In addition, the company is developing a monoclonal antibody targeting pGlu-Abeta to enhance its clearance.
To date, Probiodrug's pipeline consists of two small molecule inhibitors of the QC-enzyme, PQ912 and PQ1565, and a monoclonal antibody, PBD-C06, targeting pGlu-Abeta.
PQ912
In 2014, Probiodrug prepared its lead product candidate PQ912 for a Phase 2a study, the "SAPHIR" study. In a preceding Phase 1 study with healthy young and elderly volunteers PQ912 was shown to be safe and well tolerated and revealed high QC-inhibition.
PQ912 is the first QC-inhibitor being tested in patients. The Phase 2a study is a randomized, double-blind multi-center study, which plans to enrol a total of 110 patients with early stage Alzheimer's disease. Led by internationally renowned experts in AD in so far five European countries at about 14 sites with ongoing activities to further increase the number of 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.
In March 2015, the first patient was enrolled in the Phase 2a study at the Alzheimer Center, VU Medical Center (VUmc), Amsterdam.
PBD-C06
PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD-C06 has been successfully humanized and also de-immunized to avoid detection by the patient's endogenous immune system. Probiodrug selected PBD-C06 with a IgG2 backbone for development.
PQ1565
PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. Regulatory toxicology studies are in preparation and production of this molecule is being scaled up.
Publications
In January 2015, additional data on Glutaminyl Cyclases (QCs) and its potential role in AD was published in the journal Acta Neuropathologica. The study provides further evidence of the strong correlation between QCs and AD pathology underlining QC-inhibition as a therapeutic approach.
Patents
In 2015, Probiodrug's IP position was further strengthened by important patent applications being granted in Japan. These include:
In addition, a Notice of Allowance was released for Japanese patent application no. P2007-508347A (Use of inhibitors of Glutaminyl Cyclases for the treatment of Familial British Dementia and Familial Danish Dementia).
CORPORATE UPDATE
Financials
In the first quarter 2015, the Company has not generated any revenues. The first quarter of 2015 shows an increase of research and development expenses to TEUR 2,528 as compared to TEUR 1,302 in the first quarter of 2014 mainly due to the preparation and initiation of the SAPHIR trial. General and administrative expenses in the first quarter of 2015 show an increase to TEUR 657 as compared to TEUR 391 in the first quarter of 2014 resulting mainly from increased administration costs in the course of addressing post listing requirements, preparation of the first annual shareholders meeting as a public company and costs of the options issued in October/ November 2014. Overall, the comprehensive loss of the Company was TEUR 3,026 in the first quarter of 2015 compared to TEUR 1,717 in the first quarter of 2014. Expenditures for the first quarter 2015 have been in line with management expectations.
As at 31 March 2015 Probiodrug held EUR 18.7 million in cash and cash equivalents.
POST Q1 2015 Update
After 31 March 2015 until the date of this interim management statement, Probiodrug conducted its business in the ordinary course. There were no further special events or topics to be reported.
For more information, please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume Brophy
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 440 5653
Email: probiodrug@humebrophy.com
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, 44 million people worldwide currently live with the condition and this number is expected to almost double by 2030 and to more than triple by 2050 to over 132 million. Alzheimer's also has an estimated, global societal cost of over $600 billion (World Alzheimer Report 2014).
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.