January 2018 post
1/18/2018 4:08:35 PM
News from the development front: Tenax Therapeutics backs Levosimendan for pulmonary hypertension
Levosimendan has received a big vote of confidence at the beginning of 2018 with the announcement of Tenax Therapeutics that it will conduct a Phase II of the calcium-sensitizing drug to manage Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). As part of its development program Tenax Therapeutics has announced plans for to start its trial in PH-HFpEF in 3Q2018.
Why this move does make a lot of sense?
- Large unmet need: no drugs are approved for the treatment of PH-HFpEF, even though it is estimated to affect more than 1.5 million people only in the USA.
- Positive levosimendan data: preliminary studies are supportive of favorable effects of levosimendan in patients with pulmonary hypertension [Qiu J et al. Life Sci. 2017;184:30-36, Kleber FX et al. J Clin Pharmacol. 2009;49(1):109-15 ].
- Potential for flexible chronic therapy: thepharmacokinetics and long-lasting effects of levosimendan and its metabolite OR-1896 create potential to use chronic intermittent therapy in the treatment of PH-HFpEF.
Clinical experts who advised Tenax Therapeutics identified the novel mechanisms of action of levosimendan, initial experience with the drug in pulmonary hypertension, and its established position in the management of left and right ventricular failure, as providing a strong rationale for assessing it in PH-HFpEF.