Flamel Technologies and Digna Biotech will to jointly develop a number of the latter’s candidates using Flamel’s Medusa® and Micropump™ drug delivery technologies. Under terms of the deal Flamel will primarily be responsible for formulation and process development, with Spanish firm Digna shouldering preclinical and clinical development activities.
Three initial Digna candidates have initially been selected for co-development. P144 (disitertide) is a TGF-beta1 inhibitor that has already been evaluated in topical form in a Phase II trial as a treatment for systemic sclerosis or scleroderma. Preclinical studies in a model of organ fibrosis and macular degeneration have also been carried out. Through the collaboration with Flamel, P144 will be formulated using the Medusa platform for controlled-release subcutaneous administration, for multiple potential indications.
P17 is a preclinical-stage TGF-beta-1 in potential development for the treatment of cirrhosis, and the prevention of angiogenesis and metastasis. A Medusa-enable formulation of P17 for controlled release by subcutaneous injection will also be evaluated for multiple potential applications. The firms say clinical development of either P144 or P17 will be prioritized dependent on preclinical data from the two formulations.
The third initial candidate to be formulated using the Flamel technologies is Methylthiadenosine (MTA), an oral immunomodulator that Digna claims has demonstrated neuroprotective effects in animal models. A Micropump-enabled formulation of the drug will be developed with increased solubility and stability, for evaluation initially as a treatment for multiple sclerosis.
“By applying Flamel’s drug delivery expertise, we expect to improve the applicability of these promising candidates to the indications we are seeking to address,” remarks Pablo Ortiz, Ph.D., Digna’s CEO. “We also expect to fuel this collaboration with further innovative molecules in Digna’s pipeline as we develop further preclinical development in these programs.”
French firm Flamel’s Medusa drug delivery platform comprises proprietary nanogels for the formulation and/or extended release of a range of biologics and small molecules. The Micropump micro-encapsulation platform for orally administered drugs is designed to increase drug absorption time, and in particular those that are only absorbed in the small intestine, Flamel claims.