October 2022: first patient enrolled in IBIS study in acute ischemic stroke
September 2022: Start of investigator-initiated Phase II study at HMC to evaluate the safety, tolerability and pharmacokinetics of 2-IB in Acute Ischemic Stroke due to large vessel occlusion (IBIS Study)
August 2022: Release Clinical Batches GMP production
July 2022: VLIR-UOS TEAM 2022 proposal granted, collaboration between Neurophyxia, UNIKIN & KU Leuven to conduct the international project ‘Improving treatment and outcome of newborns with asphyxia in the Global South’
May 2022: Neurophyxia appoints Elize van der Hoeven as Chief Operating Officer
March, 2021 the results of the TIBOHCA study were analysed. The DSMB confirmed that no adverse effects can be attributed to the use of 2-iminobiotin in patients with out-of-hospital cardiac arrest.
February, 2020 the results of the clinical trial of 2-Iminobiotin for the treatment of birth asphyxia in DR Congo, a low-Income country have been published in Pediatric Drugs.
March, 2020 The phase 1 study of the safety, Tolerability, Pharmacokinetics and - Preliminary Dynamics of Neuroprotectant 2-Iminobiotin in Healthy Subjects was published in Current Clinical Pharmacology.
October 2019 a new scientific article about the 2STEP study has been accepted in Pediatric Research, "Pharmacokinetics and short-term safety of the selective NOS inhibitor 2-iminobiotin in asphyxiated neonates treated with therapeutic hypothermia".
Summer: follow up visits 2 years old patients 2STEP study
Q4 2018: Start 3e cohort Out of Hospital Cardiac Arrest study
Summer 2018: Release clinical batches GMP Production
December 2017: Successful completion of second cohort of TIBOHCA study
November 2017: DSMB approval of 2-STEP study Formulation patent granted in Russia and South Korea
June 2017: DSMB approval and start of second cohort of TIBOHCA study. Successful completion of second cohort of 2-STEP study
October 2016: Successful completion of first cohort of TIBOHCA study
September 2016: DMSB approval and start of second cohort of 2-STEP study
March 2016: Start of first cohort of investigator-initiated Phase II study at AMC Amsterdam exploring safety and pharmacokinetics of 2-IB in adults after out of hospital cardiac arrest (TIBOHCA)
August 2015: Formulation patent granted in US, China, Australia and New Zealand. In the US a continuation-in-part has been filed.
July 2015: Start of investigator-initiated Phase II study at UMC Utrecht exploring safety and pharmacokinetics of 2-IB given in addition to hypothermia in neonates with perinatal asphyxia (2-STEP study).
September 2014: Completion of hospitalisation phase of first Phase II clinical open label pilot study in Turkey.
February 2012: Approval of Paediatric Investigational Plan (PIP) by the European Medicines Agency (EMA).
June 2011: Successful completion of Phase I clinical study.
June 2010: Protocol advice received from the European Medicines Agency (EMA) in London for the first Phase II clinical study.
May 2010: Formulation patent application filed.
January 2010: Granting of Orphan Drug designation in the European Union by the European Commission.
February 2009: Granting of Orphan Drug Designation by the US FDA.
September 2008: Start of formal preclinical development of 2-IB (manufacturing and safety studies).
July 2008: Pre-IND meeting with the US FDA.
April 2008: Acquisition of the 2-IB patent family, originally filed by University Medical Center Utrecht.
Neurophyxia B.V. was incorporated on April 20th, 2008 with the founders and private investors as shareholders