Probiodrug initiates Phase 2b core program of PQ912 and details further strategy
Company moves seamlessly from finalization of the SAPHIR Phase 2a to next clinical stage
Probiodrug takes a double-pronged strategy - starts operational preparation of clinical studies with PQ912 while in parallel continuing the interaction with potential pharma partners to achieve the best value creating solution
HALLE (SAALE), Germany, 16 October 2017 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), today announced that after finalization of the SAPHIR Clinical Study Report at 25th of September 2017, it has signed a Letter of Agreement with the Contract Research Organization Julius Clinical, Zeist, NL, in order to continue the excellent collaboration of the SAPHIR study into the next development step. With this agreement the preparation of the Phase 2b core program starts which is planned to comprise of two complementary clinical Proof of Concept studies in Europe and the US.
A first Phase 2b study is intended to 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 which was established for the Phase 2a SAPHIR study. Moreover, it is based on the valuable results of the SAPHIR study and has been designed with the guidance of international KOL`s in the Alzheimer's field. Philip Scheltens MD PhD, Director of the Alzheimer Center VU University Medical Center Amsterdam will once again serve as Principle Investigator and Chairperson for this study, which is to be conducted in the EU.
A second complementary study is currently in the planning phase and is intended to be carried out in the USA and will also be chaired by a highly renowned Principle Investigator.
The envisioned Phase 2b core program will address and answer a number of important questions in order to proceed to full Phase 3 development. Key components of the tailored program are dose-dependency of tolerability and efficacy after longer treatment duration. In parallel with the preparations for the Phase 2b program, Probiodrug will continue its discussions with potential pharma partners regarding the SAPHIR results and avenues for collaboration.
Inge Lues, Chief Development Officer at Probiodrug commented: "The positive SAPHIR study results created an accelerating positive momentum toward starting a clinical Phase 2b program for PQ912. The Phase 2a results are tremendously useful in enabling the design of a tailored program comprising two clinical studies, one planned in Europe and the second in the USA. We expect that this program will answer important questions enabling us to progress PQ912 into the confirmatory Phase 3 program."
Konrad Glund, Chief Executive Officer at Probiodrug commented: ''In parallel to driving the Phase 2b initiative ourselves, we are continuing pharma interactions. The increasing evidence for targeting toxic Abeta oligomers as a key culprit of the AD pathology, in which pGlu-Abeta seems to play a significant role, is providing sound support for our efforts. We are confident that this double-pronged strategy will efficiently expedite and safeguard the advanced development of PQ912."
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Notes to Editors:
About Probiodrug AG
Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease (AD). Probiodrug has identified a new therapeutic concept linked to Alzheimer's disease initiation and progression. The development approaches are targeting a key neuro/synaptotoxic component of the pathology, pyroglutamate-Abeta (pGlu-Abeta, N3pG) as a therapeutic strategy.
Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in AD animal models. A Phase 1 study with healthy young and elderly volunteers revealed a dose dependent exposure and showed good safety and tolerability up to the highest dose showing >90% target occupancy in the spinal fluid. In June 2017 Probiodrug announced top-line data of the Phase 2a SAPHIR trial of its lead candidate (Probiodrug announces encouraging results of the Phase 2a SAPHIR Study ). The positive effects seen on secondary exploratory efficacy markers are strongly supporting (a) the hypothesis of pGlu-Abeta being synaptotoxic and (b) the therapeutic concept pursued by Probiodrug. The study revealed a positive benefit risk ratio of PQ912 and provides important guidance how to move forward in the development of PQ912 as a disease-modifying drug for AD. Altogether, the results make the program highly attractive for further development.
Complementary to the small molecule PQ912 inhibiting the formation of the synaptotoxic agent pGlu-Abeta, the company is developing PBD-C06, an anti-pGlu-Abeta-specific monoclonal antibody.The Company has medical use and composition of matter patents related to the inhibition of QC and anti-pGlu-Abeta-specific monoclonal antibodies, and has, in the Company's view, a leading position in this field of research.
Founded in 1997 by Hans-Ulrich Demuth and Konrad Glund, 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 aims to become a leading company in the development of AD treatments and to thereby provide a better life for Alzheimer's disease patients.
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.