From December 15 to 17, 2023, the ‘24th World Meeting on Sexual Medicine’ hosted by the International Society for Sexual Medicine (ISSM) was held in Dubai, UAE. This conference brought together more than 500 sexual medicine experts and scholars from over 100 countries and regions around the world to discuss the latest research achievements and challenges in the field of sexual medicine.
At this Sexual Medicine Meeting, Vigonvita showcased ONVITA? (TPN171), an innovative drug for the treatment of Erectile Dysfunction (ED). Renowned sexual medicine experts, scholars, and pharmaceutical representatives from around the world discussed the mechanism of action and clinical research results of ONVITA?, as well as the possibility of future cooperation with representatives from Vigonvita.
TPN171 is a novel highly selective phosphodiesterase type 5 (PDE5) inhibitor, which can be used for the treatment of ED. TPN171 has significant clinical efficacy, and the effective dose is lower than that of drugs with the same target, with a clinically recommended dose of 5 mg. In a randomized, double-blind, placebo-controlled, multi-center phase III clinical trial, 765 ED patients took 2.5 mg, 5 mg, 10 mg of TPN171 or placebo for 12 weeks. The results showed that all dosage groups of TPN171 significantly outperformed the placebo group in terms of improvement in erectile function, success rate of penile insertion and maintaining erection.
TPN171 has a high safety profile. No common adverse reactions such as myalgia and abnormal vision occurred in the Phase III clinical study, which are common in drugs with the same target. The results of a two-period crossover, placebo-controlled Phase I clinical study of TPN171 showed that after a single oral dose of 10 mg TPN171 under fasting condition, there was no effect on sperm motility, sperm vitality, total sperm count, density, morphology, semen volume, and semen viscosity. The results of a randomized, double-blind, placebo-controlled C-QT/QTc Phase I clinical study showed that there is no risk of QTc interval prolongation within the range of 10 mg to 50 mg after a single oral dose of TPN171 under fasting condition.
TPN171 has good?medication adherence.?The pharmacokinetic characteristics and safety of TPN171 are not affected when taken with alcohol.?The results of Phase I clinical studies in special populations showed that elderly people, patients with mild to moderate liver impairment, and patients with mild to severe renal impairment can use TPN171 without dose adjustment. In September 2022, ONVITA? was approved for marketing in Uzbekistan for the treatment of erectile dysfunction. Vigonvita has submitted a New Drug Application (NDA) for TPN171 for the treatment of erectile dysfunction in China and the NDA has been accepted.
TPN171 also has the potential to treat Pulmonary Arterial Hypertension (PAH). In a multi-center, randomized, double-blind, placebo and positive control Phase IIa clinical trial, a total of 60 patients with PAH were randomly assigned into 6 groups, each taking a single oral dose of placebo, 2.5 mg, 5 mg, 10 mg of TPN171, or 20 mg, 40 mg of Tadalafil. The results showed that the pulmonary vascular resistance of patients in the TPN171 5 mg group decreased by 16.8% compared to that of the placebo group, and the 20 mg and 40 mg of Tadalafil decreased by 15.4% and 13.3% respectively, implying that TPN171 could become a new treatment option for patients with PAH. The results of this clinical study have been published at the 2023 American Heart Association (AHA) Scientific Session.