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Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial

Soligenix, Inc. lately introduced at the moment it has reached a big milestone within the Phase 3 medical research (the “DOM-INNATE” research) for SGX942 (dusquetide) in the remedy of oral mucositis in patients with head and neck most cancers (HNC). Patient enrollment is enough to help the planned interim efficacy analysis by the unbiased Knowledge Monitoring Committee (DMC).

In accordance with the medical protocol, approximately 90 topics have been enrolled into the research as required for the deliberate interim efficacy evaluation. Within the coming weeks, topics which might be presently enrolled may have their protocol assessments completed at collaborating research facilities, including the primary endpoint assessment. The blinded knowledge will probably be verified for accuracy by the Soligenix medical staff and the info set shall be offered to an unbiased statistical analysis middle that interacts instantly with the DMC for the interim efficacy evaluation. All collaborating subjects and research centers, in addition to the Firm, will remain blinded always.

The DMC is a gaggle, unbiased of the Firm, charged with safety oversight of the medical research as well as the conduct of one, pre-specified interim efficacy analysis.  One DMC member is a statistician, with the rest consisting of clinicians educated and skilled within the illness indication being studied. The DMC convenes at pre-determined intervals (in accordance with a pre-defined constitution) to evaluation unblinded safety and efficacy knowledge. The DMC has the facility to advocate continuation or termination of the research based mostly on the analysis of those knowledge. Particular recommendations embrace stopping the research for overwhelming efficacy, stopping the research for critical safety concern, stopping the research for futility, continuing enrollment in the research at the pre-specified pattern measurement of roughly 190 topics, or re-estimating pattern measurement up or down to take care of the research’s statistical energy.

“Completing the required enrollment to support the DMC interim analysis is a significant milestone for the SGX942 program,” said Christopher J. Schaber, PhD, President and Chief Government Officer of Soligenix. “We must now wait for the last enrolled subject to reach the study’s primary endpoint measure, which will occur up to 16 weeks after entering the study. During this time, we will continue enrolling patients from the US and Europe into the trial, while looking forward to receiving the formal DMC recommendation in the September timeframe.”

Soligenix has been working with leading oncology facilities internationally, a variety of which participated in the Phase 2 research, to advance this Phase 3 medical trial referred to as the “DOM-INNATE” research (Dusquetide remedy in Oral Mucositis – by modulating INNATE immunity).

Based mostly on the constructive and beforehand revealed Phase 2 outcomes (Research IDR-OM-01), the pivotal Phase 3 medical trial (Research IDR-OM-02) is designed to be a extremely powered, double-blind, randomized, placebo-controlled, multinational trial that seeks to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to obtain a minimum complete cumulative radiation dose of 55 Gy fractionated as 2.Zero-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 each third week. Subjects are randomized to receive both 1.5 mg/kg SGX942 or placebo given twice every week during and for two weeks following completion of CRT. The first endpoint for the research is the median period of extreme oral mucositis, assessed by oral examination at each remedy visit after which via six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organisation) Grading system. Severe oral mucositis is outlined as a WHO Grade of ≥3. Topics are adopted for a further 12 months after the completion of remedy.

Affected person recruitment is anticipated to be accomplished 2019 with top-line results out there within the first half of 2020, pending the result of the interim analysis.

Mucositis is the medical term for injury executed to the mucosa by anticancer therapies. It could actually happen in any mucosal region, however is mostly related to the mouth, adopted by the small gut. It’s estimated, based mostly upon evaluate of historic revealed research and stories and an interpolation of knowledge on the incidence of mucositis, that mucositis affects approximately 500,000 individuals in the US per yr and happens in 40% of sufferers receiving chemotherapy. Mucositis may be severely debilitating and may result in an infection, sepsis, the necessity for parenteral vitamin and narcotic analgesia. The gastrointestinal injury causes extreme diarrhea. These symptoms can restrict the doses and period of cancer remedy, leading to sub-optimal remedy outcomes.

The mechanisms of mucositis have been extensively studied and have been just lately linked to the interplay of chemotherapy and/or radiation remedy with the innate protection system. Bacterial infection of the ulcerative lesions is now considered a secondary consequence of dysregulated native irritation triggered by therapy-induced cell demise, somewhat than as the first reason for the lesions.

It is estimated, based mostly upon assessment of historic revealed studies and stories and an interpolation of knowledge on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable quantity in Europe. Oral mucositis virtually all the time occurs in patients with HNC treated with CRT and is extreme, causing incapability to eat and/or drink, in >80% of sufferers. It’s common (40-100% incidence) in sufferers undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends significantly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in HNC stays an space of unmet medical want the place there are at present no permitted drug therapies.

Dusquetide (the lively ingredient in SGX942) is an IDR, a brand new class of brief, synthetic peptides. It has a novel mechanism of motion whereby it modulates the body’s response to each damage and infection in the direction of an anti-inflammatory, anti-infective and tissue therapeutic response. IDRs haven’t any direct antibiotic activity but, by modulating the host’s innate immune system responses, improve survival after infections brought on by a broad range of bacterial Gram-negative and Gram-positive pathogens. It additionally accelerates resolution of tissue injury following publicity to quite a lot of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in quite a few animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, together with melioidosis.

SGX942 has demonstrated safety in a Phase 1 medical research in 84 wholesome human volunteers. Constructive efficacy results have been demonstrated in an exploratory Phase 2 medical research in 111 sufferers with oral mucositis as a result of CRT for HNC. Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 medical trial referred to as the “DOM-INNATE” research (Dusquetide remedy in Oral Mucositis – by modulating INNATE immunity).

SGX942 has acquired Quick Monitor Designation from the FDA for the remedy of oral mucositis because of radiation and/or chemotherapy remedy in HNC sufferers, as well as Promising Progressive Drugs designation in the UK by the Medicines and Healthcare Merchandise Regulatory Company for the remedy of severe oral mucositis in HNC sufferers receiving CRT. In addition, merchandise containing the identical lively ingredient, dusquetide, have been granted Quick Monitor Designation as an adjunctive remedy with different antibacterial medicine, for the remedy of melioidosis and Orphan Drug Designations within the remedy of MAS and the remedy of acute radiation syndrome.

Soligenix has a robust mental property position in the IDR know-how platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has acquired partial funding from NIH for its oral mucositis medical research. The Phase 2 research was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 research being supported by a Phase II SBIR grant (#R44DE024032) award.

Soligenix is a late-stage biopharmaceutical company targeted on creating and commercializing products to deal with uncommon illnesses the place there’s an unmet medical need. Our BioTherapeutics enterprise phase is creating SGX301 as a novel photodynamic remedy utilizing protected seen mild for the remedy of cutaneous T-cell lymphoma, our first-in-class innate protection regulator (IDR) know-how, dusquetide (SGX942) for the remedy of oral mucositis in head and neck most cancers, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/remedy of gastrointestinal (GI) issues characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense enterprise phase consists of lively improvement packages for RiVax, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and rising infectious illness. The development of our vaccine packages incorporates using our proprietary warmth stabilization platform know-how, referred to as ThermoVax. Up to now, this enterprise phase has been supported with government grant and contract funding from the Nationwide Institute of Allergy and Infectious Illnesses (NIAID) and the Biomedical Advanced Research and Improvement Authority (BARDA). For extra info, go to www.soligenix.com.