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Associated Press
14-04-2025
- Business
- Associated Press
Positive Outcome in 75% of CTCL Patients Treated with HyBryte™ for 18 Weeks
Interim Results from FDA-Funded Study Reinforces HyBryte's™ Rapid Response and Strong Safety Profile PRINCETON, N.J., April 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Following 18 weeks of treatment, 75% of patients achieved 'Treatment Success,' reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. The IIS is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and is the Principal Investigator for the confirmatory Phase 3 FLASH2 study for the treatment of early-stage CTCL. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks in the IIS, with all data for the Week 18 timepoint now complete. Consistent with the Phase 3 trials, Treatment Success is predefined as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the eight patients who could be evaluated through Week 18, six (75%) had a Treatment Success. The 18-week treatment window is the same window that is being evaluated in the FLASH2 double-blind, placebo-controlled, randomized study that is currently enrolling patients. This rapid response is a distinct advantage of HyBryte™ therapy, with many other therapies used in CTCL taking up to six to 12 months to generate a clinically meaningful treatment response. Of these eight evaluable patients through Week 18, four have gone on to complete the 54-week treatment with an average maximum improvement in mCAILS score of 85%, three are still on treatment and one dropped out (due to logistical issues). HyBryte™ appears to be safe and well tolerated in all patients. 'The complete response rates observed, including three patients achieving a complete response on this study to date, as well as the consistent treatment response and safety profile across multiple HyBryte™ clinical studies, has been exciting to see,' noted Dr. Kim, Principal Investigator of the IIS. 'In the first Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a benign safety profile compared to the current therapies of steroids, chemotherapeutics and ultraviolet light in this chronic orphan disease. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our study funded by the U.S. Food and Drug Administration (FDA), initial results evaluating the expanded use of HyBryte™ in a 'real world' treatment setting remain very promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials. It also provides further confidence to the potential responses we can expect to see in the confirmatory Phase 3 placebo-controlled FLASH2 study. We look forward to continuing to work with the FDA to complete the IIS while we participate in the confirmatory 18-week FLASH2 study.' 'We are pleased with these recent study results, giving patients an opportunity to access the therapy in an open-label setting,' stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. 'CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective therapies. Following the initial Phase 3 FLASH study, which demonstrated the safety and efficacy of shorter courses of HyBryte™ therapy, we are pleased to see that continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients. The majority of patients show a strong treatment response by Week 18, a noticeable advantage over other therapies that may take six to 12 months to show improvement. As the body of compelling data continues to grow in support of this novel therapy, we look forward to continuing to work with Dr. Kim on this important study as well as advancing enrollment in the 80-patient confirmatory Phase 3 FLASH2 replication study. We will plan to provide additional updates on the IIS as data becomes available.' The clinical study RW-HPN-MF-01, 'Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients' is designed as an open-label, multicenter clinical trial enrolling approximately 20 patients in the U.S. Patients have the potential to be treated for up to 54 weeks with twice a week dosing (visible light activation following ointment application by 24 ± 6 hours). The study also allows for potential transition to a 'real-world' setting with home-use. The primary endpoint for the study is evaluating the number of treatment successes defined as ≥50% reduction in the cumulative mCAILS score from Baseline to end of the treatment. Study RW-HPN-MF-01 is supported by an FDA Orphan Products Development Grant of up to $2.6 million. About HyBryte™ HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA). The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte™ continued to be safe and well tolerated. Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular. The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is expected to be initiated before the end of 2024. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no 'between-Cycle' treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte's™ increased effect over a more prolonged, 'real world' treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte™ patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study is being initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback. Additional supportive studies have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01, see above), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor® (Study HPN-CTCL-04). In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study. About Cutaneous T-Cell Lymphoma (CTCL) CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas. CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually). About Soligenix, Inc. 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 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 U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma or any other studies (including the open-label, investigator-initiated study), there can be no assurance that the second HyBryte™ (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte™ (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Additionally, despite the biologic activity observed in aphthous ulcers induced by chemotherapy and radiation, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the 'SEC'), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. View original content to download multimedia: SOURCE SOLIGENIX, INC.
Globe and Mail
09-04-2025
- Health
- Globe and Mail
Behcet's Disease Market to Show Remarkable Growth Trends from 2024 to 2034, DelveInsight Reports
The Key Behcet's Disease Companies in the market include - Soligenix, Chugai Pharmaceutical, UMC Utrecht, Ganzhou Hemay Pharmaceutical, Amgen, and others. DelveInsight's 'Behcet's Disease Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Behcet's Disease, historical and forecasted epidemiology as well as the Behcet's Disease market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. Some of the key facts of the Behcet's Disease Market Report: The Behcet's Disease market size was value ~USD 140 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034) In March 2025, Christopher J. Schaber, PhD, President and CEO of Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with significant unmet needs, stated that the company remains committed to advancing its diverse clinical pipeline. Key upcoming milestones include the anticipated top-line results in 2026 from the ongoing confirmatory Phase 3 placebo-controlled trial evaluating HyBryte™ (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL). Additionally, in the latter half of this year, Soligenix expects to announce top-line data from its ongoing Phase 2 trials of SGX945 (dusquetide) for Behçet's disease and SGX302 (synthetic hypericin) for mild-to-moderate psoriasis. In November 2024, Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company dedicated to developing and commercializing therapies for rare diseases with unmet medical needs, announced the initiation of patient enrollment for its Phase 2 clinical trial (protocol number DUS-AUBD-01) assessing SGX945 (dusquetide) as a treatment for Behçet's Disease. Among the EU4 and the UK, Italy has the largest market size at around USD 10 million, followed by France with approximately USD 8 million. These figures are anticipated to change over the forecast period (2024-2034) due to ongoing research and development efforts, which may result in the discovery of more effective treatments for Behcet's Syndrome. In January 2024, Soligenix announced that the US Food and Drug Administration (FDA) has granted fast track designation to SGX945 (dusquetide) In 2023, Japan had the highest number of diagnosed prevalent cases of Behcet's syndrome among the 7MM countries. In 2023, Italy had the highest number of diagnosed prevalent cases among the EU4 and the UK, with approximately 7,000 cases. This number is expected to increase by 2034. In 2023, the total diagnosed prevalent cases of Behcet's Syndrome in the US were approximately 3,500 for pediatric patients and around 16,000 for young adults. Among the clinical manifestations of Behcet's Syndrome in the US, oral ulcers were the most prevalent, representing about 30% of the total cases, followed by genital ulcers. In the EU4 countries and the UK, oral ulcers were the most common, with approximately 5,000 cases, followed by genital ulcers, which accounted for around 3,000 cases. Key Behcet's Disease Companies: Soligenix, Chugai Pharmaceutical, UMC Utrecht, Ganzhou Hemay Pharmaceutical, Amgen, and others Key Behcet's Disease Therapies: SGX945, RAY121, Dusquetide, Filgotinib, Hemay005, Apremilast, and others The Behcet's Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Behcet's Disease pipeline products will significantly revolutionize the Behcet's Disease market dynamics. Behcet's Disease Overview Behcet's Disease is a rare, chronic, and multisystem inflammatory disorder characterized by recurring episodes of inflammation affecting various parts of the body. It is named after the Turkish dermatologist Hulusi Behçet, who first described the condition in 1937. The disease primarily affects blood vessels, causing symptoms that can involve the mouth, eyes, skin, joints, and other organs. Behcet's Disease Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Behcet's Disease Epidemiology Segmentation: The Behcet's Disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Behcet's Syndrome in the 7MM Diagnosed Cases of Behcet's Syndrome Based on the Age of Onset in the 7MM Clinical Manifestations Associated With Behcet's Syndrome in the 7MM Total Patients Seeking Treatment for Behcet's Syndrome in the 7MM Download the report to understand which factors are driving Behcet's Disease epidemiology trends @ Behcet's Disease Epidemiology Forecast Behcet's Disease Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Behcet's Disease market or expected to get launched during the study period. The analysis covers Behcet's Disease market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Behcet's Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Behcet's Disease Therapies and Key Companies SGX945: Soligenix RAY121: Chugai Pharmaceutical Dusquetide: Soligenix Filgotinib: UMC Utrecht Hemay005: Ganzhou Hemay Pharmaceutical Apremilast: Amgen Discover more about therapies set to grab major Behcet's Disease market share @ Behcet's Disease Treatment Landscape Behcet's Disease Market Strengths The constant efforts by researchers to determine clear molecular pathogenesis are progressively increasing. Studies suggest that Behcet's syndrome shares common features with autoimmune and inflammatory disorders, thus leading to the detection of the main mediators involved in the pathomechanism of Behcet's syndrome. Behcet's Disease Market Opportunities There is an attractive market for therapies with a primary goal of treatment to rapidly suppress and prevent new inflammatory attacks to avoid irreversible organ damage, especially in the early, active stages of Behcet's syndrome. As a consequence of escalating knowledge and awareness among providers and caregivers about Behcet's syndrome, the prevalence of the disease is increasing, which may further expedite the R&D. Scope of the Behcet's Disease Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Behcet's Disease Companies: Soligenix, Chugai Pharmaceutical, UMC Utrecht, Ganzhou Hemay Pharmaceutical, Amgen, and others Key Behcet's Disease Therapies: SGX945, RAY121, Dusquetide, Filgotinib, Hemay005, Apremilast, and others Behcet's Disease Therapeutic Assessment: Behcet's Disease current marketed and Behcet's Disease emerging therapies Behcet's Disease Market Dynamic s: Behcet's Disease market drivers and Behcet's Disease market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Behcet's Disease Unmet Needs, KOL's views, Analyst's views, Behcet's Disease Market Access and Reimbursement Table of Contents 1. Behcet's Disease Market Report Introduction 2. Executive Summary for Behcet's Disease 3. SWOT analysis of Behcet's Disease 4. Behcet's Disease Patient Share (%) Overview at a Glance 5. Behcet's Disease Market Overview at a Glance 6. Behcet's Disease Disease Background and Overview 7. Behcet's Disease Epidemiology and Patient Population 8. Country-Specific Patient Population of Behcet's Disease 9. Behcet's Disease Current Treatment and Medical Practices 10. Behcet's Disease Unmet Needs 11. Behcet's Disease Emerging Therapies 12. Behcet's Disease Market Outlook 13. Country-Wise Behcet's Disease Market Analysis (2020–2034) 14. Behcet's Disease Market Access and Reimbursement of Therapies 15. Behcet's Disease Market Drivers 16. Behcet's Disease Market Barriers 17. Behcet's Disease Appendix 18. Behcet's Disease Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Associated Press
21-02-2025
- Health
- Associated Press
Improving Patient Quality Of Life: Soligenix Progresses Treatment For Painful Ulcers Associated With Rare Behcet's Disease
DETROIT, MICHIGAN - February 21, 2025 ( NEWMEDIAWIRE) - The human body's circulatory system is comprised of blood vessels that carry blood away from and towards the heart. A specific distinction is that arteries carry blood away from the heart, veins carry blood back to the heart and capillaries are tiny blood vessels that connect arteries and veins, allowing for the exchange of oxygen, nutrients and waste products between the blood and body tissues. The human circulatory system is made up of about 60,000 miles of blood vessels, including arteries, veins and capillaries – this is long enough to stretch around the Earth if laid end-to-end. Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases and areas of unmet medical need, is utilizing its pharmaceutical expertise to treat Behcet's disease, an autoimmune condition mainly associated with inflammation of the blood vessels and the eyes, though the inflammation of the blood vessels often causes many different issues throughout the body. Behcet's Disease Explained Behcet's disease, or Silk Road disease, is a non-curable long-term condition caused by blood vessel inflammation. This inflammation affects and damages both the arteries and veins. Primarily diagnosed in young adults, its effects and severity will vary over time. Indications of the disease within individuals usually include mouth sores, skin rashes and lesions, genital sores, leg ulcers and eye inflammation, with inflammation of the joints observed in the most severe cases. It is a painful disease that directly impacts the patient's quality of life and ability to engage in life activities, including working productively. Demographically, as its alternate name suggests, the disease is most common along the 'Silk Road' in the Middle East and East Asia, including Turkey, Iran, Japan and China. It is less prevalent in the U.S. but can develop at any age, equally affecting both men and women. Behcet's Disease Addressable Market According to estimates compiled by Soligenix, as many as 1,000,000 people worldwide live with Behcet's Disease, with approximately 18,000 known cases in the U.S. and 80,000 in Europe. As reported by BioSpace, the market for Behcet's disease is estimated to reach $184.5 million by 2035; it is currently valued at $105.1 million (2024). The market growth is attributed to the adoption of advanced, minimally invasive treatment options such as biologic therapies, monoclonal antibodies and targeted immunomodulators. These treatments effectively address underlying inflammation and systemic symptoms while reducing side effects and long-term reliance on corticosteroids, such as prednisone. Current therapies suppress inflammation and immune function. Soligenix's Treatment Of Behcet's Disease Soligenix's drug candidate for treating Behcet's disease is SGX945. Dusquetide, the active ingredient in SGX945, 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, they can increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. Dusquetide also accelerates the resolution of tissue damage following exposure to a variety of agents, including bacterial pathogens, trauma and chemo- and/or radiation therapy. SGX945's treatment is administered as a 4-minute IV infusion twice a week. It is intended for use to enhance the resolution of oral, genital and skin ulcer flares in Behçet's Disease. In 2024, Soligenix announced the phase 2 clinical trial of SGX945 in treating Behcet's Disease. The clinical trial will be an open-label study that will enroll approximately 25 patients aged 18 years or older with mild to moderate Behcet'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. Regarding the launch of the clinical study, Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, stated, 'We are pleased to have received FDA clearance and Turkish Medicines and Medical Devices Agency (Turkey's Ministry of Health) authorization to start patient enrollment into our SGX945 Phase 2a pilot trial in aphthous ulcers of Behcet's Disease. Our previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. Given the role of the innate immune system in ulcers associated with Behcet's Disease, and the unmet medical need particularly for more severe ulcers such as genital and leg ulcers, we believe that dusquetide may offer significant relief to patients. We are excited to expand dusquetide's development into different innate immune-related inflammatory conditions, such as Behcet's Disease, as a component of our long-term strategy to enhance the value of this unique compound.' Looking Ahead The launch of the phase 2 clinical trial of SGX945 is a milestone moment for Soligenix. As the firm progresses in treating Behcet's Disease and other rare diseases, it is looking to establish a distinct value proposition in the market that cannot be easily replicated or counter-positioned against. As the firm continues on its product development initiatives, new opportunities for sustainable growth may emerge over time, potentially strengthening its market position. Featured photo by Lucas Vasques on Unsplash.
