September 15, Tenax Therapeutics announced a delay in the initiation of the Phase III clinical trial for its oral imatinib drug, TNX-201, for pulmonary arterial hypertension (PAH). The estimated date has shifted from H2 2022 to 2023 as part of a strategic evaluation of the company’s financial resources. This is good news for Tenax’s main competitor, Aerovate, which has an ongoing Phase IIb/III trial for dry powder inhalation imatinib, AV-101. Both formulations have received orphan drug designation from the FDA and hold the potential to become the first-in-class tyrosine kinase inhibitor (TKI) drug for PAH.
PAH is characterized by abnormal pulmonary vascular remodeling and vasoconstriction. One highly unmet need in the PAH space is the absence of disease-modifying therapies targeting vascular remodeling. Currently marketed PAH drugs—including endothelin receptor antagonists, PDE5 inhibitors, soluble guanylyl cyclase stimulators, and prostacyclin derivatives—promote vasodilation or prevent vasoconstriction, but do not alter disease progression. Imatinib targets a novel pathway by blocking the activation of the tyrosine kinase receptor PDGFR to inhibit vascular remodeling. Oral imatinib is currently marketed globally for several oncogenic indications by Novartis under the brand name Gleevec in the US. After showing promise in animal studies, Novartis investigated oral imatinib as a repurposed drug for PAH in the IMPRES Phase III trial. Results from the trial published in 2013 showed a significant improvement in exercise capacity and vascular resistance in PAH patients over 24 weeks compared to placebo. However, reports of serious adverse events in 44% of patients and high discontinuation rates (33%) prompted the FDA to request further trials to assess its safety before approval. Subsequently, Novartis discontinued investigating oral imatinib for PAH.
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September 15, Tenax Therapeutics announced a delay in the initiation of the Phase III clinical trial for its oral imatinib drug, TNX-201, for pulmonary arterial hypertension (PAH). The estimated date has shifted from H2 2022 to 2023 as part of a strategic evaluation of the company’s financial resources. This is good news for Tenax’s main competitor, Aerovate, which has an ongoing Phase IIb/III trial for dry powder inhalation imatinib, AV-101. Both formulations have received orphan drug designation from the FDA and hold the potential to become the first-in-class tyrosine kinase inhibitor (TKI) drug for PAH.
PAH is characterized by abnormal pulmonary vascular remodeling and vasoconstriction. One highly unmet need in the PAH space is the absence of disease-modifying therapies targeting vascular remodeling. Currently marketed PAH drugs—including endothelin receptor antagonists, PDE5 inhibitors, soluble guanylyl cyclase stimulators, and prostacyclin derivatives—promote vasodilation or prevent vasoconstriction, but do not alter disease progression. Imatinib targets a novel pathway by blocking the activation of the tyrosine kinase receptor PDGFR to inhibit vascular remodeling. Oral imatinib is currently marketed globally for several oncogenic indications by Novartis under the brand name Gleevec in the US. After showing promise in animal studies, Novartis investigated oral imatinib as a repurposed drug for PAH in the IMPRES Phase III trial. Results from the trial published in 2013 showed a significant improvement in exercise capacity and vascular resistance in PAH patients over 24 weeks compared to placebo. However, reports of serious adverse events in 44% of patients and high discontinuation rates (33%) prompted the FDA to request further trials to assess its safety before approval. Subsequently, Novartis discontinued investigating oral imatinib for PAH.