$AYTU in the NEWS ---> Wired News – Acceleron Ph

$AYTU in the NEWS ---> Wired News – Acceleron Pharma Commences PULSAR Phase-2 Trial of Sotatercept in Pulmonary Arterial Hypertension


LONDON, UK / ACCESSWIRE / May 24, 2018 / If you want access to our free research report on Acceleron Pharma Inc. (NASDAQ: XLRN), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=XLRN as the Company's latest news hit the wire. On May 22, 2018, the Company announced that it has commenced the PULSAR Phase-2 trial of sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH), which is a chronic and life-changing disease that can lead to heart failure. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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The preliminary results from the 6-month primary treatment period of the PULSAR Phase-2 trial are expected in the first half of 2020.

Primary Endpoint of PULSAR Trial is Change from Baseline in Pulmonary Vascular Resistance over a 24-week Treatment Period

The PULSAR Phase-2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sotatercept in PAH patients. The primary endpoint of the trial is the change from baseline in pulmonary vascular resistance (PVR) over a 24-week treatment period. The key secondary endpoint is the change from baseline in a six-minute walk distance (6MWD). A total of 90 patients will be randomized 1:1:1 into three treatment arms with standard-of-care vasodilator therapies, in combination with sotatercept or placebo. Following the 6-month double-blind treatment period, participants in the trial will be eligible to enroll into the 18-month extension period.

Treatment with Sotatercept Could Restore a Vital Signaling Pathway that is Known to be Deficient in PAH Patients

Habib Dable, Chief Executive Officer (CEO) of Acceleron, stated that the initiation of the PULSAR trial is an important milestone in the Company's newly expanded research and development (R&D) efforts in pulmonary disease. Dable added that Acceleron believes that treatment with sotatercept could restore a vital signaling pathway that is known to be deficient in PAH patients. This is an extremely important trial, as the Company hopes to bring an innovative medicine to the thousands of patients who are suffering from PAH.

Acceleron's Agreement with Celene to Develop Sotatercept in PAH

In September 2017, the Company announced its amended agreement with Celgene Corp. for sotatercept's development and commercialization, originally executed on February 20, 2008. The amended agreement provided Acceleron with global access to sotatercept for development and commercialization in PAH. Under the amended and restated collaboration agreement, Acceleron has the right to fund and conduct all R&D activities for sotatercept in the pulmonary hypertension field. Acceleron is also responsible for global commercialization and Celgene is eligible to receive royalties on global net sales in that field. The original collaboration deal terms remain in place with respect to development and commercialization outside of the pulmonary hypertension field.

About Pulmonary Arterial Hypertension (PAH)

PAH is a condition of increased blood pressure within the arteries of the lungs. The symptoms include shortness of breath, syncope, tiredness, chest pain, swelling of the legs, and a fast heartbeat. The condition may make it difficult to exercise. The cause of PAH is often unknown. The risk factors include a family history, prior blood clots in the lungs, HIV/AIDS, sickle cell disease, cocaine use, COPD, sleep apnea, living at high altitudes, and problems with the mitral valve.