The HELP Study’s findings are the foundation for the oral levosimendan patent.
Tenax Therapeutics’ patent application for its oral levosimendan, TNX-103, to treat pulmonary hypertension combined with heart failure with preserved ejection fraction (PH-HFpEF), has been granted a Notice of Allowance by the US Patent and Trademark Office (USPTO).
The patent, once issued, will provide the company in the United States with additional protection and intellectual property protection until December 2040.
For the same purpose, the USPTO granted a patent in March for the intravenous administration of levosimendan.
Levosimendan is a calcium sensitizer and an activator of the potassium ATP channel.
The HELP Study’s important findings form the basis for the drug’s most recent patent.
Patients with PH-HFpEF who received levosimendan experienced a statistically significant improvement in their ability to walk 29 meters in six minutes when compared to patients who received a placebo.
Tenax Therapeutics boss clinical official Dr Stuart Rich said: ” In light of its exceptional robotic properties as both a potassium ATP channel activator and calcium sensitiser, we accept oral levosimendan has a novel chance to turn into the very first treatment supported for the treatment of PH-HFpEF, the most widely recognized kind of PH worldwide.
“The only medication that has demonstrated a significant improvement in exercise capacity for this patient population is intravenous levosimendan, as demonstrated in the Phase II HELP Study.”
“Importantly, we have also received guidance from the FDA that the primary endpoint in our Phase III program can be the same six-minute walking test used in the Phase II HELP Study.”
Moreover, the organization intends to initiate a Stage III preliminary of the levosimendan oral detailing this year.
Source – pharmaceutical