Tenax Therapeutics’ announcement of a delay in its Phase III trial for its oral imatinib drug, TNX-201, in the treatment of pulmonary arterial hypertension (PAH), has pushed its main competitor Aerovate Therapeutics further into the lead with its inhaled imatinib drug, AV-101, according to GlobalData, a leading data and analytics company.

Kaya Olczak, Healthcare Analyst at GlobalData, comments: “One highly unmet need in the PAH space is an absence of disease-modifying therapies. Previously, Novartis attempted to reformulate its oral Imatinib, a tyrosine kinase inhibitor currently marketed for several oncogenic indications. However, despite promising clinical efficacy, reports of serious adverse events and high discontinuation rates resulted in Novartis terminating the investigation. Tenax and Aerovate believe their respective imatinib oral and inhaled formulations will have better safety profiles, whilst maintaining clinical efficacy.”

Tenax expects that its reformulated oral imatinib, TNX-201, will reduce the incidence of serious adverse events, specifically gastric intolerance. However, AV-101 will hold more potential if it maintains efficacy in Phase III trials, due to its improved safety profile. Phase I safety data shows reduced systemic exposure of the inhalation drug, and Aerovate believes this will improve the benefit-to-risk ratio over oral imatinib.

Olczack adds: “Phase IIb/III clinical trials of AV-101 were initiated in 2021  and have an expected completion date in 2025. If successful, GlobalData forecasts that AV-101 will launch in 2027, one year prior to the launch of TNX-201. Following the delay of Tenax’s TNX-201 Phase III initiation, AV-101 now holds an even stronger competitive advantage as the first-in-class tyrosine kinase inhibitor for PAH.”