close

Products

Date: 2016-12-12

Type of information: Granting of a patent

Product name: dusquetide (SGX942)

Compound: dusquetide

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

  • peptide. SGX942 is an innate defense regulator (IDR), which contains a new class of short, synthetic peptide, having the chemical name dusquetide. This compound 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 with 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. SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients exposed to the most aggressive concomitant chemotherapy, the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). The p-values meet the prospectively defined statistical threshold of pDusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. SGX942 has received fast track designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients.

Company: Soligenix (USA - NJ)

Disease: oral mucositis

Latest news:

  • •  On December 12, 2016, Soligenix announced that SGX942 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy. The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS). Launched in April 2014, EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible. PIM status, the first phase of EAMS, which is awarded following an assessment of early nonclinical and clinical data by the MHRA, has been created as an early signal to companies that the development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme, once further development work has been conducted. In this second phase, the product is made available to UK patients before a marketing authorization is approved. This early boost to a drug's potential is expected to be beneficial to companies, especially small and medium-sized enterprises. The criteria products must meet to obtain the PIM designation are: Criterion 1 - The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations). Criterion 2 - The medicinal product is likely to offer major advantage over methods currently used in the UK. Criterion 3 - The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence, as justified by the applicant, that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits.

Patents:

  • • On January 2, 2018, Soligenix announced that the US Patent Office has granted the patent entitled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis” (number 9,850,270, issued on December 26, 2017).  The newly issued patent claims therapeutic use of dusquetide and related innate defense regulator (IDR) analogs, and adds to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. Dusquetide previously demonstrated positive results in a Phase 2 oral mucositis clinical trial and a pivotal Phase 3 study was recently initiated in 2017.
  • Soligenix has reported positive Phase 2 results with SGX942 in the treatment of oral mucositis in head and neck cancer (HNC) patients. SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their HNC. In addition to the oral mucositis findings, an increased incidence of “complete response” of tumor at both the one month and twelve month follow-up visits were observed with SGX942 treatment, as well as decreases in mortality and infection rate. Results from the Phase 2 clinical trial have been published.• On September 6, 2016, Soligenix announced that the United States (US) Patent Office granted the patent entitled "Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity." Patent number 9,416,157 was granted on August 16, 2016.  This newly issued patent claims composition of matter of analogs of dusquetide (research name: SGX94). Dusquetide recently demonstrated positive preliminary results in a Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer patients. The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform. Similar claims have been granted and/or are being pursued in jurisdictions worldwide.
  • • On April 14, 2016, Soligenix announced that the Chinese Patent Office intends to grant the patent entitled "Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity." The newly issued patent claims composition of matter of dusquetide (SGX94) and related analogs. Dusquetide recently demonstrated positive results in a Phase 2 oral mucositis clinical trial. China now becomes the most recent jurisdiction to grant patent coverage over the composition of matter of dusquetide. Similar claims have been granted in the United States, Australia, Israel, Japan, Mexico, New Zealand, Republic of Korea, Russian Federation, Singapore, South Africa and Taiwan. Furthermore, Soligenix is expecting to be granted similar protections in other important jurisdictions, including Europe, in the very near term.
  • The new patents correspond to US patent 8,124,721, granted on February 28, 2012, that primarily included composition of matter claims and therapeutic use claims in infectious disease for dusquetide.

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes