IND-ready drug targets terminal kinase MK2 in TGF-β/p38 signaling pathway.

MicroDose Therapeutx and Moerae Matrix inked a collaboration agreement to develop an inhaled dry powder formulation of the latter’s lead MAPKAP kinase 2 (MK2) inhibitor MMI-0100, which has completed preclinical development for the treatment of idiopathic pulmonary fibrosis. Under terms of the collaboration MicroDose will develop and supply a pulmonary drug delivery system using its inhaler technology, which will be suitable for chronic administration.

“MicroDose’s piezo-driven dry powder inhaler platform is the optimal technology for delivering our fist-in-class peptide therapeutic for treatment of IPF,” comments Cynthia Lander, Ph.D., Moerae’s chairman and CEO.

Biopharmaceutical firm Moerae is commercializing technology licensed from Purdue University to develop antifibrotic peptide therapeutics that target MK2. MMI-0100 is the firm’s first development candidate, now poised to start in clinical development for acute fibrotic indications. Development of the drug is being funded in part by the National Heart, Lung and Blood Institute under the Science Moving Towards Research Translation and Therapy (SMARTT) program. Moerae says it is looking for partners with the development and commercial expertise to progress MMI-0100 development programs in IPF and intimal hyperplasia.

The target MK2 is a key terminal kinase in the TGF-β/p38 signaling pathway, and Moerae maintains that by targeting a terminal kinase, MMI-0100 could exhibit greater specificity of action and lower off-target toxicity than antifibrotic drugs that impact on upstream TGF-β/p38 targets. In addition, the firm claims, while studies in the bleomycin mouse model of pulmonary fibrosis show that other agents demonstrate antifibrotic activity only when dosed prophylactically, MMI-011 demonstrates therapeutic effects by reducing collagen deposition even when first dosed days after the onset of fibrosis.

MicroDose is developing an in-house and partnered pipeline of drugs based on its solid oral dosage, inhaled and transdermal needle-free delivery platforms. The firm’s in-house pipeline includes a Phase I-stage inhalable small molecule anti-viral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus (RSV) and an inhaled atropine product that is also in Phase I development for biodefense applications as an antidote against nerve gas poisoning.

The RSV candidate was licensed to MicroDose by Viropharma in 2009 and is now in development in partnership with Gilead. Data from the second of two Phase I trials evaluating the drug were reported in April. MicroDose’s preclinical in-house projects include products against constipation, COPD, and autoimmune disorders. 

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