Date: 2016-10-11
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at National Organization for Rare Disorders' (NORD's) Rare Diseases and Orphan Products Breakthrough Summit
Company: Soligenix (USA - NJ)
Product: dusquetide (SGX942)
Action
mechanism: peptide. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. This peptide is an Innate Defense Regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.
Disease: macrophage activation syndrome
Therapeutic area: Rare diseases
Country:
Trial details:
Latest
news: * On October 11, 2016, Soligenix announced that it has been invited to present preliminary results from two programs at National Organization for Rare Disorders' (NORD's) Rare Diseases and Orphan Products Breakthrough Summit on October 17-18, 2016 in Arlington, VA. The presented results will address preclinical efficacy findings in two programs that have previously been granted orphan drug designation by the FDA :
Dusquetide in the treatment of macrophage activation syndrome (MAS); and RiVax™, a proprietary thermostable ricin toxin vaccine, for the prevention of ricin intoxication.
Dusquetide (the active ingredient in SGX942) is a first-in-class Innate Defense Regulator. It modulates the response of the innate immune system in response to various stimuli, including infection, tissue damage and inflammation. Dusquetide has shown preclinical efficacy in an extensive array of preclinical models emphasizing all 3 aspects of its activity. As will be presented, the drug is effective in a preclinical model of MAS. This finding is supported by dusquetide's ability to improve survival in models of bacteremia which also feature excess innate immune pro-inflammatory signaling. Clinical activity, highlighting the anti-inflammatory action of dusquetide, has also been obtained in both Phase 1 and Phase 2 clinical studies. Results from the Phase 2 study recently demonstrated that dusquetide can reduce the duration of severe oral mucositis, caused by the excessive inflammatory response of the innate immune system to damage caused by chemoradiation, in head and neck cancer patients.
An Innate Defense Regulator for the Treatment of Macrophage Activation Syndrome: Preclinical Studies in an Orphan Indication (poster)
