A clinical-stage biotech company from China named Biosciences Co. Ltd has announced today about the recent FDA approval on one of its drugs. U.S. Food and Drug Administration (FDA) has granted this company’s approval for its “Investigational New Drug (IND) trial” that works on a tiny molecular inhibitor of phosphodiesterase (TT-00920) for treating patients of heart failure.
This approval would begin phase one of the clinical trials to ensure drug safety and its tolerability. It would further investigate its pharmacokinetics and pharmacodynamics in healthy individuals. These trial studies would begin within the first half of 2020.
Dr. Frank Wu is the founding father and the current CEO of TransThera. He says that this new IND approval for TT-00920 is indeed a significant event for the company. He believes that it could be a new transformative treatment for the patients of chronic heart failure and specifically those which suffer from HFpEF.
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HFpEF is a type of heart failure with preserved ejection fraction. This condition is diagnosed by cardiac catheterization and echocardiography. Nearly 50% of heart failure patients also suffer from preserved ejection fraction and the rest experience reduced ejection fraction of HFrEF.
Chronic heart failure (CHF) is a highly prevalent syndrome that is caused by any structural or functional impairment in heart or a problem with ventricular blood filling or blood ejection. It is prevalent in all parts of the world and older patients are the most common targets of chronic heart failure.
Aging is one factor that could cause multiple morbidities and co-morbidities. Currently, more than 26 million people are affected by this condition. The available treatment options have surely affected patient’s outcomes but still, it is one of the biggest reason of hospitalization of senior citizens (typically over 65 years age) and represent a big financial and medical burden.
Common risk factors for heart failure with preserved ejection fraction are
- Excessive smoking
- Obstructive sleep apnea
There is a huge controversy on the link between diastolic heart failure and heart failure with preserved ejection fraction. heart failure with preserved ejection fraction typically represents an abnormal diastolic heart function where the left ventricle becomes stiffer and causes a decrease in left ventricle relaxation time during the diastolic period.
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TT-00920 is a selective PDE9 inhibitor for heart failure which may be studied to treat heart failure patients in the future. This inhibitor hinders the body’s natural system which balances the stress on heart halves. The inhibition of PDE9 with TT-00920 would restore the natural cardio-protective function that is otherwise disturbed in heart patients.
The preclinical report from TransThera Biosciences reveals that TT-00920 can improve cardiac function and converse the ventricular remodeling in patients with chronic heart failure. Since 2016, this company is working to design new therapeutic options for major diseases such as cancer, cardiovascular problems, and inflammatory diseases. This new success on TT-00920 is this company’s second big achievement that is in clinical development.