Company Update (NYSEMKT:MSTX): Mast Therapeutics Inc Announces Agreement For Phase 2 Study Of AIR001 To Be Conducted By The Heart Failure Clinical Research Network


Mast Therapeutics Inc (NYSEMKT:MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, today reported that its wholly-owned subsidiary, Aires Pharmaceuticals, Inc., has entered into an agreement with Duke University to provide support for a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study of the Company’s product candidate AIR001 in patients with heart failure with preserved ejection fraction (HFpEF). This 100-patient study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study, will be sponsored by Duke Clinical Research Institute (DCRI) as theCoordinating Center for the Heart Failure Clinical Research Network (HFN) and conducted at premier clinical centers in the United States that are part of the HFN.

HFpEF is a common form of heart failure that has not responded as well to previously tested treatments as heart failure with reduced ejection fraction. AIR001, a sodium nitrite solution that is administered by way of intermittent inhalation via nebulization, was obtained by Mast Therapeutics in 2014 through the acquisition of then privately-held Aires Pharmaceuticals.  The Company recently reported positive top-line results from a blinded and randomized Phase 2a clinical study of AIR001 in HFpEF patients conducted at Mayo Clinic.

The HFN was established by the NHLBI to expedite clinical research on treatments and strategies to improve the management of acute and chronic heart failure. The HFN’s work is supported by a grant awarded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).  Under the agreement with the HFN Coordinating Center, as previously anticipated, the Company will provide test materials, nebulizers, and regulatory, technical and additional financial support.

The Chair of the HFN Executive Committee is Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine at Harvard Medical School.  The collaborative scientific leadership for the study will include Dr.Barry Borlaug, the Principal Investigator, and other investigators from the HFN Regional Coordinating Centers.  The HFN Coordinating Center will be led by Dr. Adrian Hernandez and Dr. Kevin Anstrom of the DCRI.

“We appreciate the NIH’s, NHLBI’s, and HFN’s recognition of the study of AIR001 in heart failure as an appropriate area of investigation,” stated Brian M. Culley, Chief Executive Officer of Mast Therapeutics, Inc.”This study will accelerate efforts to define the potential efficacy of AIR001 for patients who have heart failure with preserved ejection fraction. This is an area of significant unmet need. There are more than 1 million heart failure hospitalizations each year in the U.S., about half are patients with HFpEF, and, currently, there are no proven effective therapeutic agents available for this large patient population.”

“The investigator initiated Investigational New Drug Application (IND) has been submitted and DCRI anticipates that the study will begin recruiting patients in the third quarter of this year,” continued Mr. Culley. “We look forward to supporting DCRI and the HFN on this study.” (Original Source)

Shares of Mast Therapeutics are up nearly 7% to $0.35 in pre-market trading. MSTX has a 1-year high of $0.60 and a 1-year low of $0.21. The stock’s 50-day moving average is $0.27 and its 200-day moving average is $0.39.

On the ratings front, MSTX has been the subject of a number of recent research reports. In a report issued on February 23, Maxim Group analyst Jason McCarthy reiterated a Buy rating on MSTX, with a price target of $5, which represents a potential upside of 1433.7% from where the stock is currently trading. Separately, on February 1, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $3.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and John Newman have a total average return of -1.7% and -13.7% respectively. McCarthy has a success rate of 36.4% and is ranked #2921 out of 3790 analysts, while Newman has a success rate of 26.4% and is ranked #3774.

Mast Therapeutics, Inc. is a biopharmaceutical company, which engages in developing novel therapies for serious or life-threatening diseases with significant unmet needs. Its lead product MST-188 has cytoprotective and hemorheologic properties and inhibits inflammatory processes and thrombosis. The company was founded by Warren C. Lau in December 1995 and is headquartered in San Diego, CA.

 

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