Madeleine Receives NIH SBIR Grant for heart failure drug Vastiras®
$2 million funding will advance IND enabling studies for Phase II clinical trials for MP3167 (Vastiras®)
MAY 6, 2016
Madeleine Pharmaceuticals, Inc. announced today that the National Heart, Lung and Blood Institute has awarded the company a $2 million grant under the Small Business Innovation Research (SBIR) program. The funds will be used by Madeleine to support its clinical programs to further the development of MP3167 as the recombinant biologic form of human proANP 31-67 and formulated as Vastiras® for intravenous or Vastiras®XT for subcutaneous administration as a co-therapy in the treatment of acute heart failure (AHF) patients.
Specifically, the NHLBI grant will allow Madeleine to conduct three critical IND-enabling studies as outlined in discussion with the FDA. These studies advance the recombinant human form of proANP 31-67 using Madeleine’s proprietary manufacturing process and include bioequivalence to previously used synthetic forms in clinical trials, extensive toxicological analyses and significant scaling and optimization of recombinant manufacturing.
Phase II clinical trials conducted by the company to date have demonstrated predictable pharmacokinetic behavior of intravenous and subcutaneous administration of MP3167 and evidence of improved renal function and diuretic responsiveness in congestive and acutely decompensated AHF patients. Vastiras® is intended to support a “continuum of care” from hospitalization through discharge with compliance at home. Madeleine’s currently proposed Phase II program aims to definitively establish cardiorenal improvement in the HF patient and provide clinical evidence for continued development. This funding will advance the FDA’s clear path to initiate a Phase IIa “first-in-CHF patient” trial for the company’s recombinant biologics program (US IND 124,001).
About NIH SBIR Grants
National Institute of Health’s grants under the Small Business Innovation Research (SBIR) program funds early stage small businesses that are seeking to commercialize innovative biomedical technologies. This competitive program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs (https://sbir.nih.gov/).
Vastiras® represents a new drug class with features and benefits for improved cardiorenal function currently not available in the HF markets. Madeleine has identified one of three N-terminal peptides from atrial natriuretic peptide prohormone (“proANP”) encompassing amino acid sequence 31-67 as its lead candidate MP3167 for clinical studies. MP3167 will be formulated as Vastiras® and Vastiras®XT for the vulnerable HF discharge patient as a renal co-therapy, to address renal function and diuretic response in concert with established HF front-line drug therapies.
In addition to its growing intellectual property portfolio for the therapeutic use of Vastiras®, Madeleine has rights to the proprietary manufacturing process developed in partnership with Hospira Pty (Australia) for the recombinant biologic form of human proANP 31-67 that can provide significant cost savings for market production. Collectively, these create strong value in Vastiras® for its commercialization objectives globally and ideally suit it for near-term pharma partnership or acquisition.
About Madeleine Pharmaceuticals, Inc.
Madeleine Pharmaceuticals, Inc. is a U.S. biotechnology company seeking to develop MP3167 (Vastiras®) as protein replacement therapy for the treatment of cardiorenal complications associated with acute (AHF) and chronic (CHF) heart failure. Vastiras® can be formulated for both in-patient and out-patient care.
Madeleine Pharmaceuticals, Inc. was incorporated in 2014 and its corporate structure was updated in 2015, in anticipation of managing and leading the clinical development programs in the U.S. This also enabled unencumbered access to the IP in Madeleine Pty Ltd., the original company formed in 2009 in Australia after being spun out of a leading biomedical company Hospira (former NYSE:HSP), now wholly owned by Pfizer Pharmaceuticals, Inc. (NYSE:PFE) by acquisition in 2015. Madeleine Pty Ltd. maintains an Australian presence for Madeleine Pharmaceuticals, Inc. with access to regional grants, research expertise and Asian markets among other benefits. Madeleine is supported by an experienced management team, board of directors, and advisors.