FDA Clears IND Application for Phase II Pulmonary Arterial Hypertension Trial

According to a story from news.cision.com, the US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CS1, an investigational drug being developed by the biotech company Cereno Scientific. The acceptance of this application is a critical step on the path of drug development that will allow the company to conduct a phase II clinical trial. CS1 is being developed to treat pulmonary arterial hypertension, a rare disease. 

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplants. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.

About the Trial

The trial will investigate CS1’s efficacy, safety, tolerability, and dosing in patients living with the disease. The experimental treatment employs a different mechanism of action from other treatments. This could allow for it to be an innovative treatment that could improve outcomes for pulmonary arterial hypertension patients.

CS1 was also previously given Orphan Drug designation from the FDA in March 2020 for the treatment of this disease. This clinical trial is projected to include around 30 patients and will take place in six different sites.

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