Accelerating the Clinical Path of NTP42
A Disease-modifying Drug that will Disrupt the Future Treatment of Cardiopulmonary Diseases, including Pulmonary Arterial Hypertension (PAH).
Through the European Innovation Council (EIC) Accelerator program, ATXA Therapeutics' PAH-ADVANCE project has been awarded blended finance with €2.5 million in grant and up to €8 million in equity funding to advance the clinical development of NTP42 to a Phase II clinical trial in pulmonary arterial hypertension (PAH) patients.
Click here to find out more about EIC funding opportunities
Project Overview
Following the completion of ATXA’s first-in-human (FIH) Phase I clinical trial showing NTP42 as safe, well tolerated & efficacious in man with good pharmacokinetic profiles, the EIC blended finance along with VC equity co-investment will allow the company to complete the next stages of preclinical and clinical development. This includes completing the scaled-up manufacture and formulation of NTP42 as a drug-in-capsule for oral dosing along with its validation in a Bridging Clinical Trial in healthy participants. It will also enable completion of the long-term drug safety and toxicology evaluations and securing regulatory approval for the Phase II clinical trial in PAH patients, an important objective of PAH-ADVANCE.
Manufacture
& Formulation
Scaled-up Drug Manufacture & Development of a Drug-in-Capsule form of NTP42
Regulatory Preparation
Negotiations & Applications for Phase II Regulatory Approval in Europe and North America
Drug Safety & Toxicology
Completion of All Necessary Drug Safety Studies & Toxicology Assessments
Phase II Clinical Trial
Evaluation of NTP42 in an International Phase II Clinical
Trial in PAH
Patients
Bridging Clinical Trial
Validation of NTP42 Drug-in-Capsule in a Bridging Clinical Trial in Healthy Volunteers
Product Diversification
Diversify NTP42 and ATXA's Compounds to Target Other Relevant Disease Indications
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