PDC Biotech GmbH (PDC) is a private biopharmaceutical company developing innovative therapeutics for the treatment of preterm labour and primary dysmenorrhea, two areas of significant unmet medical need and large market potential.
The primary focus for the company is the development of a pipeline of products which are antagonists of the receptor for prostaglandin F2α (FP receptor). PDC has licensed exclusive worldwide rights to a family of FP receptor antagonists from Theratechnologies Inc. (www.theratech.com) which include both peptides (compounds composed of at least two amino acids) and peptidomimetics (peptide-like compounds).
The company has successfully completed a phase I clinical trial for its lead compound PDC31in healthy women with primary dysmenorrhea. This study was designed to evaluate safety as well as provide proof-of-concept for the ability of the compound to inhibit excessive uterine contractility. In this study PDC31 infusion was associated with a dose-dependent relief of pain, as well as a reduction in intrauterine pressure. In addition, the drug was very well tolerated and there were no dose limiting toxicities.
In non-clinical pharmacology studies, PDC31 has been shown to block uterine contractions in in vitro and in animal models of preterm labour that are the industry standard models used to predict results in humans. Excessive uterine contractility mediated by PGF2? is involved in both preterm labour and primary dysmenorrhea, and the company's resources can be used to develop both core programs in tandem, thereby reducing development costs. PDC31 is an intravenous (IV) formulation, which is suitable for development in preterm labour, which is treated in a hospital setting and requires a rapid onset of action. The company is also developing a non-IV formulation (PDC41 Series) which would be more convenient for use in primary dysmenorrhea, where the patient would self-administer the drug.
The company's initial focus has been on obtaining clinical proof-of-concept of the ability of PDC31 to stop uterine contractions in healthy women with primary dysmenorrhea. The positive outcome of this study enables moving forward with further development for the preterm labour indication.
PDC has a well thought-out clinical development strategy which has been discussed with clinical experts in both the US and Europe. Patent applications claiming composition of matter, pharmaceutical compositions and therapeutic uses of the peptides and peptidomimetics have been filed in all major jurisdictions and respective patents have already issued in the US, Europe, Canada, Japan and Australia.
In September, 2009 PDC closed a Series A round of financing of over €4 million and since then has closed extensions to the Series A round of approximately €1.9 million. MIG Verwaltungs AG (Munich) and Edmond de Rothschild Investment Partners (Paris) co-led the investment. In addition to Series A the company had previously received €1 million in seed funding from the Austrian Wirtschaftsservice (AWS) and a grant of €517, from the Zentrumfür Innovation und Technologie (ZIT; an agency of the City of Vienna for promotion of innovation and technology).