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Clinical Trials

Date: 2017-09-14

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the World Anti-Microbial Resistance Congress

Company: Soligenix (USA - NJ)

Product: dusquetide

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.
  • Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections. Some of these preclinical findings have been published in an article entitled "A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy," available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

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Latest news:

  • • On September 14, 2017, Soligenix has presented the anti-infective activity of the dusquetide technology platform and its utility in anti-microbial resistance  at the World Anti-Microbial Resistance Congress. The presentation has addressed dusquetide's novel mechanism of anti-inflammatory, anti-infective and tissue-healing action, including effectiveness data from the SGX942 Phase 2 clinical trial in oral mucositis.
  • Dusquetide is an Innate Defense Regulator (IDR) which has demonstrated preclinical activity in bacterial infection models as both a stand-alone agent and as a synergistic treatment with antibiotics. Dusquetide is equally effective irrespective of the bacterial pathogen, with efficacy demonstrated with gram-positive and gram-negative bacteria as well as with bacteria occupying intracellular or extracellular niches and bacteria with antibacterial resistance mechanisms. The IDRs leverage a unique mechanism of action, acting at a key intracellular convergence point in the innate immune pathways, facilitating a multi-dimensional impact on the response of the innate immune system to any stimulus, ameliorating tissue damage and increasing survival following exposure to a variety of agents, including a broad range of bacterial pathogens, trauma and radiation or chemotherapy. Dusquetide has been demonstrated to be clinically effective in modulating the innate immune system. In a Phase 2 clinical trial in oral mucositis in which SGX942, the drug product containing dusquetide, not only reduced the duration of severe oral mucositis in response to chemotherapy and radiation therapy induced tissue damage in head and neck cancer patients, but also reduced the incidence of infections in patients treated with SGX942. Building upon positive Phase 2 data, Soligenix has recently initiated a pivotal Phase 3 clinical trial with SGX942 in this patient population.

Is general: Yes