MicroDose Therapeutx & Moerae Matrix Announce Collaboration


MicroDose Therapeutx, Inc. and Moerae Matrix, Inc. recently announced they have signed a collaboration agreement to develop a dry powder inhalation product of Moerae’s novel MK2 inhibitor, MMI-0100, for the treatment of idiopathic pulmonary fibrosis (IPF), a serious and fatal lung disease for which there are no approved treatments in the US. The collaboration will involve the development and supply of a pulmonary drug delivery system for Moerae and/or its partners utilizing MicroDose’s proprietary inhaler technology in support of chronic administration.

“We are pleased to be partnering with a recognized industry leader in pulmonary drug delivery to advance development of MMI-0100 for IPF,” said Cynthia Lander, PhD, Chairman and Chief Executive Officer of Moerae Matrix. “MicroDose’s piezo-driven dry powder inhaler platform is the optimal technology for delivering our first-in-class peptide therapeutic for treatment of IPF.”

“Moerae has assembled an impressive team to advance this promising treatment approach for this debilitating disease, and we are pleased to be able to contribute to its advancement,” added Scott Fleming, Senior Vice President, Sales and Marketing for MicroDose. “This collaboration in IPF expands the utilization of MicroDose’s inhalation technology into yet another extremely important disease area.”

MMI-0100 is a selective inhibitor of MAPKAP kinase 2 (MK2), a key terminal kinase in the transforming growth factor beta (TGF-beta)/p38 signaling pathway. By targeting a terminal kinase, MMI-0100 has the potential for greater specificity of action and lower off-target toxicity than other anti-fibrotic agents that address targets higher in this important pathway.

“IPF represents an enormous unmet medical need and delivering a drug directly to the lung that inhibits a down-stream kinase in the TGF-beta/p38 pathway is extremely appealing. It is very likely that multiple drugs that interfere with different components of fibrosis will be needed to combat IPF and MK2 inhibition is a novel and exciting target for drug development in this devastating disease,” said Paul W. Noble, MD, Professor of Medicine and Chief, Division of Pulmonary, Allergy and Critical Care Medicine, Duke University Medical Center.

“Developing therapeutics for local delivery is a very desirable approach for the treatment of lung diseases in general, and IPF in particular. Doing so should minimize the risk of systemic effects while targeting a kinase now known to be involved in fibrogenesis. Accordingly, this is an attractive approach for treating such a lethal disease,” explained David S. Wilkes, MD, Executive Associate Dean for Research Affairs, August M. Watanabe Professor for Medical Research, Indiana University School of Medicine.

Development of MMI-0100 for treatment of IPF is being funded in part with federal support from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) in the Department of Health and Human Services (DHHS), under the Science Moving TowArds Research Translation and Therapy (SMARTT) program (NHLBI Contract No. HHSN268201100017C).

Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal lung disease in which fibrous tissue replaces the alveolar sacs through which we breathe. Over time, scarring of lung tissue causes progressive loss of the ability to breathe effectively, with 70% chance of death occurring within 5 years. There are no approved drug treatments for IPF in the US, with the standard of care currently lung transplant.

MMI-0100 is in preclinical development for treatment of idiopathic pulmonary fibrosis and other fibrotic conditions. In the bleomycin mouse model, the industry standard for study of pulmonary fibrosis, MMI-0100 has demonstrated a therapeutic benefit by abrogating collagen deposition when dosed after the onset of fibrosis. MMI-0100’s anti-fibrotic activity has consistently been demonstrated in multiple models of fibrotic conditions, including pulmonary fibrosis, vascular intimal hyperplasia, and post-surgical adhesions. Across model systems, MMI-0100 demonstrates excellent in vivo potency.

The company has compiled a full IND-enabling data package on MMI-0100; the compound also demonstrates a favorable toxicology profile and highly scalable manufacturing process.

Moerae Matrix is a privately held biopharmaceutical company focused on the development of first-in-class targeted therapeutics for fibrotic disease. For more information, visit www.moeraematrix.com.

MicroDose Therapeutx is a private pharmaceutical company dedicated to improving the quality of life for people suffering from serious diseases. The company focuses on developing proprietary pulmonary and oral products that address large unmet market opportunities, and on dry powder inhalation, and combination oral dosage delivery platforms. For more information, visit www.mdtx.com.