WÜRZBURG, Germany, January 21, 2016 /PRNewswire/ --

Phase III registration study of VAS203 to commence in H1 2016  

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, today announced it has successfully raised EUR 20 million of new capital.  The financing was co-led by existing investors Entrepreneurs Fund, Heidelberg Capital Private Equity and new investor, UK based Fort Rock Capital. Existing investors Bayern Kapital and funds advised by Hanseatic Asset Management LBG also participated in the round. Dr Mario Alberto Accardi, Venture Partner at Fort Rock Capital will be joining the Board of the company as a Non-Executive Director.

The EUR 20 million will fully fund a pivotal, European Phase III study with vasopharm's lead product VAS 203 in moderate to severe Traumatic Brain Injury (TBI). All preparatory groundwork for the clinical trial has been finalised over the last 12 months and "First patient in" is expected in H1 2016.

Christian Wandersee, Chief Executive Officer of vasopharm, commented: "We are delighted to have successfully raised EUR 20 million to conduct a Phase III study of VAS203, bringing a drug for a highly unmet need closer to market. TBI is a very challenging indication which has proven intractable to all previous pharmacological intervention. We have been extremely rigorous in analysis of our exceptional Phase II data and believe that, in VAS203, we have a drug which will provide physicians with a real opportunity to improve long-term outcomes in this devastating condition."

Dr Andrew Clark, Chairman of the Board of vasopharm added: "This fundraising is a strong financial and scientific endorsement of the pipeline and management team.  We appreciate the commitment of our existing investors and the continued confidence they have shown in vasopharm.  We would like to welcome Dr Mario Alberto Accardi to the Board and look forward to benefiting from his expertise as we advance our programs."

VAS203 Phase II results demonstrated statistically significant improvements to both short term (Therapy Intensity Level) and long term (extended Glasgow Outcome Scale, 6 months and 12 months) measures of treatment efficacy.  Following interaction with the European Medicines Agency (EMA) vasopharm has designed a Phase III registration study in Europe which, if successful, would lead to regulatory submission of VAS203 for the treatment of moderate and severe TBI. VAS203 has been granted orphan drug status for the treatment of moderate to severe TBI by the EMA. Severe TBI alone is estimated to cost the European Union EUR 33 billion annually. ^[1]

P+P Pöllath + Partners, Munich provided legal advice to the company; Jones Day, Munich to the investor Entrepreneurs Fund and funds advised by Hanseatic Asset Management LBG, Hogan Lovells, Frankfurt to new Investor Fort Rock Capital and Weitnauer Rechtsanwaelte, Munich to Bayern Kapital. 

Notes to editors: 

About Traumatic Brain Injury: 

Traumatic brain injury (TBI) occurs when a sudden trauma causes damage to the brain. Every year, over 1,600,000 patients sustain a traumatic brain injury in the EU, and 70,000 of these die, with a further 100,000 being left disabled. Significantly, 75% of the victims are children and young adults, and TBI is the leading cause of disability in people under 40 years of age. Traumatic brain injury results in more lost working years than cancers, stroke and HIV/AIDS together.  On a global scale, the number of life years lost due to traumatic brain injury is four times that of diabetes-related loss. Recent statistics show a steep increase in the incidence of TBIs, with an increase of 21% over the last five years - threefold greater than the rate of increase in population, at an annual cost of over Euros 100 billion. Despite this, TBI has been seriously underrepresented in medical R&D efforts compared to many other, less significant health problems. ^[2]

References: 

1. Olesen, J. et al,, "The economic cost of brain disorders in Europe.", Eur J. Neurol. 2012 Jan (19) 1: 155 - 62
2. http://www.tbicare.eu

About VAS203: 

VAS203 is an analogue of the natural co-factor biopterin, which is involved in the generation of nitric oxide by the Nitric Oxide Synthase (NOS) family of enzymes. The mechanism of action of VAS203 is believed to confer selective down regulation of inducible NOS (iNOS) without significantly inhibiting the function of other NOS enzymes. It is believed that iNOS has a significant involvement in the cascade of damaging sequellae following a traumatic brain injury. Technical : VAS203 is (4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride dehydrate) a structural analogue of (6R)-5,6,7,8-tetrahydro-L-biopterin, the natural endogenous cofactor of NOS and phenylalanine hydroxylase. Data for pharmacokinetics, pharmacodynamics, metabolites and surrogate markers measured in the brain during VAS203 studies is a key differentiator to all other previous clinical trials in TBI which provides strong support for the potential of a positive outcome in this trial.  

About vasopharm GmbH: 

vasopharm is focused on the development of small molecule therapeutics which modulate the bioavailability of biological NO, by addressing the entire NO/cGMP signal cascade and its functional counterpart NOX. vasopharm's drug candidate VAS203 represents a completely new class of NOS modulators targeting cerebral vessels and cerebral tissue. For VAS203, vasopharm received orphan drug designation for the treatment of moderate and severe TBI in Europe.

For further information, please contact:

vasopharm GmbH
Christian Wandersee, CEO
Tel: +49-931-359099-0
Email: wandersee@vasopharm.com

Hume Brophy
Mary Clark, Eva Haas, Hollie Vile
Tel: +44-2034405654
Email: vasopharm@humebrophy.com  

SOURCE vasopharm