WÜRZBURG, Germany I July 11, 2019 I vasopharm GmbH, a private biopharmaceutical company developing a novel treatment for traumatic brain injury (TBI), today announced the successful completion of a € 9.5 million financing co-led by HeidelbergCapital Private Equity and EF Investments. Existing investors Bayern Kapital, Future Capital, clients of Hanseatic Asset Management and Ringtons Holdings also participated in the round. In addition, vasopharm welcomed Creathor Ventures as new investor and Christian Leikert, Partner at Creathor Ventures, joins vasopharm’s board of directors.
vasopharm’s lead product, Ronopterin (VAS203), is in Phase III development for the treatment of moderately to severely injured closed head TBI patients. TBI is the leading cause of death and disability among young adults in the developed world and there is no existing drug treatment available1
Ronopterin, an allosteric iNOS (inducible Nitric Oxide Synthase) inhibitor, is currently in a 220 patient pivotal European NOSTRA III (NO Synthase in TRAumatic Brain Injury) trial which is on course to complete recruitment in Q4 of this year. vasopharm’s NOSTRA III is the most advanced commercial pharmacological TBI programme currently in human clinical trials in the world.
The funding will enable vasopharm to complete Chemistry, Manufacturing, and Controls (CMC) scale up and stability testing in preparation for commercial scale production, ahead of the potential filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). In addition, the company will explore additional indications which it believes to be mechanistically similar.
Christian Wandersee, Chief Executive Officer of vasopharm, commented: “Following the DMC recommendation to continue the NOSTRA III trial as per protocol, we are delighted to close this funding round, and now have the resources to complete all necessary steps to support a possible clinical data submission in 2020. We are pleased to welcome Creathor Ventures to vasopharm and would like to thank our existing investors for their continued support. This funding will enable us to develop and deliver an essential therapeutic option to both physicians and patients who experience the devastating and life-long consequences of TBI.
Annually, in Europe alone, head trauma is the cause of about 2.5 million emergency room visits, roughly 1,000,000 hospital admissions, nearly 75,000 deaths and approximately 100,000 cases of severe long-term disability (e.g. functional and cognitive disorders, learning disabilities). The global economic burden of TBI is estimated at about $400 billion also taking indirect costs into consideration (e.g. productivity loss).
NOTES TO EDITOR
About vasopharm GmbH:
vasopharm is a drug development company focused on small molecule therapeutics for treatment of Traumatic Brain Injury (TBI). vasopharm’s lead drug candidate VAS203 (Ronopterin) is currently in the Phase III NOSTRA trial assessing efficacy and safety of VAS203 for the treatment of moderately to severely injured closed head traumatic brain injury patients
Current approaches to the treatment of acute TBI focus on short term patient mortality and have no significant impact on reducing long-term physical and cognitive deficits. VAS203 avoids unwanted side effects, combined with unprecedented clinical efficacy. The European regulator, EMA has granted the drug orphan drug designation for moderate to severe brain injury
vasopharm was founded in July 1998 as a spin-off from the University of Würzburg Medical School by Harald Schmidt, MD, PhD, Professor of Pharmacology and Toxicology, and Ulrich Walter, MD, Professor of Clinical Biochemistry and Pathobiochemistry. To date, the company has raised about Euros 50 million to date through several financing rounds from various Family Investment Offices and Venture Investors.
See www.vasopharm.com for further details.
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 under-represented in medical R&D efforts compared to many other, less significant health problems.1
About VAS203:
VAS203 is an analogue of the natural co-factor tetrahydrobiopterin, 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 sequelae following a traumatic brain injury. Technical: VAS203 is (4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride dihydrate) a structural analogue of (6R)-5,6,7,8-tetrahydro-L-biopterin, the natural endogenous cofactor of NOS and phenylalanine hydroxylase.
About NOSTRA III
NOSTRA III is a randomised, double-blind, placebo-controlled trial. The study will enroll 220 patients who have suffered a moderate to severe TBI resulting in hospitalisation and who have received an intra-cranial pressure probe. Currently, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain are participating. The primary endpoint is the eGOS evaluated at six months after the injury. Secondary efficacy assessments include Quality of Life (QOLIBRI) as well as Therapy Intensity Level (TIL) over 14 days after brain injury. NOSTRA III is a registration trial which seeks to validate the data from the highly significant NOSTRA II trial.* The study aims to confirm the data from a Phase II trial in which VAS203 has shown a (2 point) improvement in the extended Glasgow Outcomes Score.
1. www.tbicare.eu
*Journal of Neurotrauma 31:1599-1606 (October1 2014).
SOURCE: vasopharm
Post Views: 154
WÜRZBURG, Germany I July 11, 2019 I vasopharm GmbH, a private biopharmaceutical company developing a novel treatment for traumatic brain injury (TBI), today announced the successful completion of a € 9.5 million financing co-led by HeidelbergCapital Private Equity and EF Investments. Existing investors Bayern Kapital, Future Capital, clients of Hanseatic Asset Management and Ringtons Holdings also participated in the round. In addition, vasopharm welcomed Creathor Ventures as new investor and Christian Leikert, Partner at Creathor Ventures, joins vasopharm’s board of directors.
vasopharm’s lead product, Ronopterin (VAS203), is in Phase III development for the treatment of moderately to severely injured closed head TBI patients. TBI is the leading cause of death and disability among young adults in the developed world and there is no existing drug treatment available1
Ronopterin, an allosteric iNOS (inducible Nitric Oxide Synthase) inhibitor, is currently in a 220 patient pivotal European NOSTRA III (NO Synthase in TRAumatic Brain Injury) trial which is on course to complete recruitment in Q4 of this year. vasopharm’s NOSTRA III is the most advanced commercial pharmacological TBI programme currently in human clinical trials in the world.
The funding will enable vasopharm to complete Chemistry, Manufacturing, and Controls (CMC) scale up and stability testing in preparation for commercial scale production, ahead of the potential filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). In addition, the company will explore additional indications which it believes to be mechanistically similar.
Christian Wandersee, Chief Executive Officer of vasopharm, commented: “Following the DMC recommendation to continue the NOSTRA III trial as per protocol, we are delighted to close this funding round, and now have the resources to complete all necessary steps to support a possible clinical data submission in 2020. We are pleased to welcome Creathor Ventures to vasopharm and would like to thank our existing investors for their continued support. This funding will enable us to develop and deliver an essential therapeutic option to both physicians and patients who experience the devastating and life-long consequences of TBI.
Annually, in Europe alone, head trauma is the cause of about 2.5 million emergency room visits, roughly 1,000,000 hospital admissions, nearly 75,000 deaths and approximately 100,000 cases of severe long-term disability (e.g. functional and cognitive disorders, learning disabilities). The global economic burden of TBI is estimated at about $400 billion also taking indirect costs into consideration (e.g. productivity loss).
NOTES TO EDITOR
About vasopharm GmbH:
vasopharm is a drug development company focused on small molecule therapeutics for treatment of Traumatic Brain Injury (TBI). vasopharm’s lead drug candidate VAS203 (Ronopterin) is currently in the Phase III NOSTRA trial assessing efficacy and safety of VAS203 for the treatment of moderately to severely injured closed head traumatic brain injury patients
Current approaches to the treatment of acute TBI focus on short term patient mortality and have no significant impact on reducing long-term physical and cognitive deficits. VAS203 avoids unwanted side effects, combined with unprecedented clinical efficacy. The European regulator, EMA has granted the drug orphan drug designation for moderate to severe brain injury
vasopharm was founded in July 1998 as a spin-off from the University of Würzburg Medical School by Harald Schmidt, MD, PhD, Professor of Pharmacology and Toxicology, and Ulrich Walter, MD, Professor of Clinical Biochemistry and Pathobiochemistry. To date, the company has raised about Euros 50 million to date through several financing rounds from various Family Investment Offices and Venture Investors.
See www.vasopharm.com for further details.
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 under-represented in medical R&D efforts compared to many other, less significant health problems.1
About VAS203:
VAS203 is an analogue of the natural co-factor tetrahydrobiopterin, 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 sequelae following a traumatic brain injury. Technical: VAS203 is (4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride dihydrate) a structural analogue of (6R)-5,6,7,8-tetrahydro-L-biopterin, the natural endogenous cofactor of NOS and phenylalanine hydroxylase.
About NOSTRA III
NOSTRA III is a randomised, double-blind, placebo-controlled trial. The study will enroll 220 patients who have suffered a moderate to severe TBI resulting in hospitalisation and who have received an intra-cranial pressure probe. Currently, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain are participating. The primary endpoint is the eGOS evaluated at six months after the injury. Secondary efficacy assessments include Quality of Life (QOLIBRI) as well as Therapy Intensity Level (TIL) over 14 days after brain injury. NOSTRA III is a registration trial which seeks to validate the data from the highly significant NOSTRA II trial.* The study aims to confirm the data from a Phase II trial in which VAS203 has shown a (2 point) improvement in the extended Glasgow Outcomes Score.
1. www.tbicare.eu
*Journal of Neurotrauma 31:1599-1606 (October1 2014).
SOURCE: vasopharm
Post Views: 154
