Soligenix Initiates a Phase 2 Clinical Trial of SGX945 (dusquetide) for the treatment of Behçet's Disease
Soligenix (SNGX) has initiated patient enrollment for a Phase 2 clinical trial evaluating SGX945 (dusquetide) in treating Behçet's Disease. The study received clearance from both FDA and Turkish authorities. The open-label trial will enroll approximately 25 patients with mild to moderate Behçet's Disease and active oral/genital ulcers. Patients will receive twice-weekly IV infusions for 4 weeks, followed by 4 weeks of follow-up. The company expects to announce results in the first half of 2025. The disease affects up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and about 1 million worldwide.
Soligenix (SNGX) ha avviato l'arruolamento dei pazienti per una sperimentazione clinica di Fase 2 che valuta SGX945 (dusquetide) nel trattamento della malattia di Behçet. Lo studio ha ricevuto l'approvazione sia dalla FDA che dalle autorità turche. La sperimentazione aperta arruolerà circa 25 pazienti con malattia di Behçet da lieve a moderata e ulcere orali/genitali attive. I pazienti riceveranno infusioni endovenose due volte a settimana per 4 settimane, seguite da 4 settimane di monitoraggio. L'azienda prevede di annunciare i risultati nella prima metà del 2025. La malattia colpisce fino a 18.000 persone negli Stati Uniti, 50.000 in Europa, 350.000 in Turchia e circa 1 milione in tutto il mondo.
Soligenix (SNGX) ha iniciado el reclutamiento de pacientes para un ensayo clínico de Fase 2 que evalúa SGX945 (dusquetide) en el tratamiento de la enfermedad de Behçet. El estudio recibió la autorización de la FDA y de las autoridades turcas. El ensayo abierto reclutará aproximadamente a 25 pacientes con enfermedad de Behçet leve a moderada y úlceras orales/genitales activas. Los pacientes recibirán infusiones intravenosas dos veces por semana durante 4 semanas, seguidas de 4 semanas de seguimiento. La compañía espera anunciar los resultados en la primera mitad de 2025. La enfermedad afecta a hasta 18,000 personas en EE. UU., 50,000 en Europa, 350,000 en Turquía y alrededor de 1 millón en todo el mundo.
Soligenix (SNGX)는 Behçet병 치료를 위한 SGX945 (dusquetide)의 2상 임상시험에 환자 등록을 시작했습니다. 이 연구는 FDA와 터키 당국의 승인을 받았습니다. 이 개방형 시험은 경증에서 중등도의 Behçet병과 활동성 구강/생식기 궤양을 가진 약 25명의 환자를 등록할 예정입니다. 환자들은 4주 동안 주 2회 정맥 주사를 받으며, 이후 4주간의 추적 관찰이 진행됩니다. 이 회사는 2025년 상반기 내에 결과를 발표할 것으로 예상하고 있습니다. 이 질병은 미국에서 최대 18,000명, 유럽에서 50,000명, 터키에서 350,000명, 전 세계적으로 약 100만 명에게 영향을 미칩니다.
Soligenix (SNGX) a commencé le recrutement de patients pour un essai clinique de Phase 2 évaluant SGX945 (dusquetide) dans le traitement de la maladie de Behçet. L'étude a obtenu l'autorisation de la FDA et des autorités turques. L'essai ouvert recrutera environ 25 patients atteints de la maladie de Behçet légère à modérée et d'ulcères oraux/génitaux actifs. Les patients recevront des perfusions intraveineuses deux fois par semaine pendant 4 semaines, suivies de 4 semaines de suivi. La société prévoit d'annoncer les résultats dans la première moitié de 2025. La maladie touche jusqu'à 18 000 personnes aux États-Unis, 50 000 en Europe, 350 000 en Turquie et environ 1 million de personnes dans le monde.
Soligenix (SNGX) hat die Patientenrekrutierung für eine Phase-2- klinische Studie zum Einsatz von SGX945 (dusquetide) zur Behandlung der Behçet-Krankheit gestartet. Die Studie erhielt die Genehmigung von der FDA und den türkischen Behörden. In der offenen Studie werden etwa 25 Patienten mit leichter bis moderater Behçet-Krankheit und aktiven oralen/genitalen Geschwüren rekrutiert. Die Patienten erhalten wöchentlich zwei intravenöse Infusionen über einen Zeitraum von 4 Wochen, gefolgt von 4 Wochen Nachbeobachtung. Das Unternehmen erwartet, die Ergebnisse in der ersten Hälfte des Jahres 2025 bekannt zu geben. Die Erkrankung betrifft bis zu 18.000 Menschen in den USA, 50.000 in Europa, 350.000 in der Türkei und weltweit etwa 1 Million Menschen.
- Expansion into new therapeutic area with significant market potential (1 million patients worldwide)
- Previous studies validated biologic activity in aphthous ulcers
- Received both FDA and Turkish regulatory clearances for trial initiation
- Small trial size of only 25 patients may limit statistical significance
- Results not expected until first half of 2025
Insights
This Phase 2 trial initiation for SGX945 represents a strategic expansion into the Behçet's Disease market, targeting a significant unmet medical need. The study design appears well-structured, with 25 patients receiving twice-weekly treatments over 4 weeks, followed by a 4-week follow-up period.
The market opportunity is substantial, with a potential patient population of 1 million worldwide, including 18,000 in the U.S. and 350,000 in Turkey. The company's focus on Turkey for the trial is strategic, given it has the highest prevalence of Behçet's Disease globally.
Previous validation of dusquetide's efficacy in oral mucositis provides a reasonable scientific basis for this indication expansion. However, investors should note that this is an early-stage, open-label study without a control group, which may limit the strength of conclusions that can be drawn from the results.
Study DUS-AUBD-01 opens patient enrollment
"We are pleased to have received FDA clearance and Turkish Medicines and Medical Devices Agency (
The pilot clinical trial of SGX945 will be an open-label study that will enroll approximately 25 patients age 18 years or older with mild to moderate Behçet's Disease and active oral and/or genital ulcers. Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for 4 weeks followed by 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient reported quality of life assessments.
About Dusquetide
Dusquetide, the active ingredient in SGX945 (Behçet's Disease) and SGX942 (oral mucositis), is an innate defense regulator (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, anti-infective, and tissue healing 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 Gram-negative and Gram-positive bacterial pathogens. Dusquetide 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 have been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome as well as bacterial infections. In addition, potential anti-tumor activity has been demonstrated in multiple in vitro and in vivo xenograft studies.
Dusquetide has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits.
Soligenix has a strong intellectual property position in the IDR technology 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
About Behçet's Disease
Behçet's Disease is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately
Behçet's Disease is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the "Silk Road" in the
There is no cure for Behçet's Disease, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post-thrombotic syndrome. Other treatments for Behçet's Disease flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in Behçet's Disease is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast must be used continuously to be effective and is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.
About Soligenix
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment, the expected timing for closing the offering described herein and the intended use of proceeds therefrom. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the
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