2024

September 2024: Neurophyxia is attending BIO-Europe Fall 2024 in Stockholm, Sweden, November 4-6, 2024.

May 2024: First patient enrolled in the TIBC-II study, a multicentre randomized double-blind placebo-controlled Phase IIb trial evaluating the short-term efficacy and safety of 2-IB in neonates with moderate to severe perinatal asphyxia in DRC.

March 2024: Neurophyxia attends the 18th edition of BIO-Europe Spring in Barcelona, Spain on March 18-20, 2024

February 2024: Approval from the Congolese Health Authorities (ACOREP) to start the multicentre Phase IIb trial TIBC-II evaluating the short-term efficacy and safety of 2-IB in neonates with moderate to severe perinatal asphyxia in Kinshasa, DRC. The Clinical Trial Application was submitted in close collaboration with the University Clinics Kinshasa, DRC and the University of Leuven, Belgium. The study protocol is approved by the Ethics Committee of the School of Public Health of the University of Kinshasa. The trial is registered at the Pan African Clinical Trial Register (PACTR202308870380725).

February 2024: Presentation of preliminary results of IBIS study at Late-Breaking Sciences - International Stroke Conference 2024, Phoenix Arizona. Title Poster: Safety, pharmacokinetics and preliminary efficacy of the neuroprotectant 2-iminobiotin in patients with Ischemic Stroke treated with mechanical thrombectomy.

2023

September 2023: Enrollment of patients completed in IBIS study (phase II double blind randomised placebo controlled trial) in acute ischemic stroke.

September 2023: Neurophyxia is invited as panellist and participates at the Conect4Children Multi-Stakeholder Meeting on Perinatal Asphyxia, Rome. 

September 2023: Neurophyxia announces the publication of the article entitled “2-iminobiotin, a selective inhibitor of nitric oxide synthase, improves memory and learning in a rat model after four vessel occlusion, mimicking cardiac arrest”.  The results of the study, published in PLOS ONE (see link), demonstrate that 2-Iminobiotin, administered directly upon reperfusion, significantly improves long term memory and learning in a 4VO rat model model of global ischemia. On top of the results of Neurophyxia’s lead compound 2-Iminobiotin in Phase IIa clinical trials, showing excellent safety and tolerability and predictive PK in adults after cardiac arrest and neonates with perinatal asphyxia, this study underscores the unique potential of 2-Iminobiotin as a neuroprotectant in cerebral hypoxia ischemia and reperfusion injury.

June 2023: The results of the phase IIa TIBOHCA study, investigating safety, tolerability and pharmacokinetics of 2-iminobiotin after cardiac arrest in adults, have been published in Frontiers in Neurology (see link). The study shows that 2-iminobiotin has an excellent safety profile with predictable PK after correction for renal function on admission. Promising – though preliminary-  neuronal biomarker, mortality and CPC data have been obtained, for reference (see link). Based on the results of the TIBOHCA study, the optimal dose for next phases of clinical development was identified.

May 2023: recruitment of IBIS trial in acute ischemic stroke half way without any safety concerns.

February 2023:  Neurophyxia successfully passed the GMP inspection by the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) on February 2nd 2023. The IGJ inspection confirmed Neurophyxia to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no major or critical observations were issued. As a result from this successful inspection, a GMP Certificate has been issued extending Neurophyxia’s GMP status.

2022

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

2021

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.

2020

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.

2019

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".

2018

Q4 2018: Start 3e cohort Out of Hospital Cardiac Arrest study
Summer 2018: Release clinical batches GMP Production

2017

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

2016

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)

2015

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).

2014

September 2014: Completion of hospitalisation phase of first Phase II clinical open label pilot study in Turkey.

2012

February 2012: Approval of Paediatric Investigational Plan (PIP) by the European Medicines Agency (EMA).

2011

June 2011: Successful completion of Phase I clinical study.

2010

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.

2009

February 2009: Granting of Orphan Drug Designation by the US FDA.

2008

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