"Fibrotic organ failure, and in particular [idiopathicpulmonary fibrosis] (IPF), is a terrible disease with a high mortality rate, andthere are no effective treatments at this time," Douglas E. Williams, EVP,R&D at Biogen Idec, said in a press release. "We believe STX-100 has thepotential to be a best-in-class therapy and it is an excellent strategic fitwith our focus on highly differentiated programs with the potential to make areal difference for patients. The Phase 2 program complements our scientificexpertise and advances our research and development efforts in immunology. Weare pleased to welcome Mike and his team back to Biogen Idec to drive STX-100'scontinued development. Their work in advancing STX-100 through Phase 1 anddeveloping biomarkers to inform upcoming clinical trials increases thelikelihood of bringing a much-needed therapy to patients. This acquisition bringstogether our scientific strengths and capabilities with a clear goal ofproviding highly effective therapies to patients suffering from fibrosis."
STX-100 is Stromedix's lead candidate, a novel humanizedmonoclonal antibody that selectively disrupts the TGF-beta pathway, which isknown to figure centrally in fibrotic disease. In preclinical animal models,the compound was shown to cause significant anti-fibrotic activity in additionto displaying an appealing safety and tolerability profile in Phase I trials.In addition, Stromedix also has pinpointed a series of clinical biomarkers thatreflects STX-100's biological activity, and the compound is entering a Phase IItrial in patients with IPF. The compound has exhibited anti-fibrotic activityin preclinical models of lung, kidney and liver disease, and Stromedix notes onits website that it intends to develop the novel molecule in several clinicalindications.
IPF is a debilitating lung disease which is almost uniformlyfatal, and currently, no treatment for the disease has yet won U.S. Food andDrug Administration approval. Patients with IPF suffer from progressivebreathing problems due to fibrosis, or scarring, of the lungs, and more than200,000 patients in the United States and Europe suffer from the disease.
"With a well-established understanding of the fundamentalbiology and tremendous unmet medical need, fibrosis is one of the most excitingand dynamic areas of drug development today," Michael Gilman, Ph.D., Founderand CEO of Stromedix, said in a press release. "We appreciate Biogen Idec'sfocus in immunology and their tremendous international R&D and commercialcapabilities. By joining forces, we expect to accelerate the development ofSTX-100 and other promising early-stage drug candidates. This begins a newchapter for all of us at Stromedix, and we look forward to a bright future aspart of Biogen Idec."
Prior to the founding of Stromedix, Gilman led Biogen Idec'sresearch organization from 2000 to 2005.
SOURCE: Stromedix press release
