Probiodrug: Emerging Details Of PQ912 Late-stage Development
Edison | Apr 13, 2018 08:05AM ET
The highlight of Probiodrug's (AS:PDB) FY17 results presentation was the rather detailed introduction of the Phase IIb development programme for the lead asset PQ912, a small molecule inhibitor of glutaminyl cyclase (QC) for Alzheimer’s disease (AD) patients. Two Phase IIb trials (in Europe and the US) are designed to gather the amount of data that, if sufficiently positive, could allow for accelerated or conditional regulatory approval. The first Phase IIb study in Europe is expected to start by end 2018 and Probiodrug is exploring all options for funding sources. After several modest changes to our model, our updated valuation is slightly higher at €513m, €62.4/sh.
European/US Phase IIb studies could lead to market
The preliminary design for the European Phase IIb trial SAPHIR 2 have been presented. The design of the Phase IIb US study should be substantially similar in regard to patent population and titration, but will likely include additional readouts and treatment period will be 18 months including an interim analysis. The primary endpoint is PQ912’s effect on cognitive function measured by the neuropsychological test battery (NTB). NTB was one of the exploratory endpoints in the Phase IIa trial with PQ912 and showed initial signs of positive changes in cognitive function of AD patients after a short, three-month treatment period. AD patients will be treated for about a year on average in the upcoming European trial. If the data are sufficiently positive from both the US and European trials, Probiodrug expects to initiate a discussion with the regulatory authorities for accelerated or conditional approval (we assume in 2023).
To read the entire report Please click on the pdf File Below:
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.