HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma
Soligenix (SNGX) announced interim results from an open-label study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). The study, supported by a $2.6M FDA grant, shows promising outcomes with over 70% of eligible patients (5 of 6) achieving 'Treatment Success' - defined as ≥50% improvement in mCAILS score.
Of the nine enrolled patients treated for up to 54 weeks, three achieved Treatment Success within 12 weeks, with two reaching complete response by week 18. Two patients recently started the study, while two dropped out for logistical reasons, with one showing >30% improvement at Week 18. The treatment appears safe and well-tolerated across all patients.
The study (RW-HPN-MF-01) aims to enroll approximately 20 U.S. patients for up to 12 months of twice-weekly dosing, with potential transition to home use. This research extends previous positive Phase 2 and 3 clinical trials results.
Soligenix (SNGX) ha annunciato risultati preliminari da uno studio in aperto che valuta il trattamento prolungato con HyBryte™ per il linfoma cutaneo a cellule T (CTCL) in fase iniziale. Lo studio, sostenuto da una sovvenzione FDA di 2,6 milioni di dollari, mostra risultati promettenti con oltre il 70% dei pazienti idonei (5 su 6) che raggiungono il 'Successo del Trattamento' - definito come un miglioramento ≥50% nel punteggio mCAILS.
Dei nove pazienti arruolati trattati per un massimo di 54 settimane, tre hanno raggiunto il Successo del Trattamento entro 12 settimane, con due che hanno ottenuto una risposta completa entro la settimana 18. Due pazienti hanno iniziato recentemente lo studio, mentre due si sono ritirati per motivi logistici, con uno che ha mostrato un miglioramento >30% nella settimana 18. Il trattamento sembra essere sicuro e ben tollerato da tutti i pazienti.
Lo studio (RW-HPN-MF-01) mira ad arruolare circa 20 pazienti negli Stati Uniti per un massimo di 12 mesi di dosaggio due volte a settimana, con una possibile transizione all'uso domestico. Questa ricerca amplia i risultati positivi dei precedenti trial clinici di Fase 2 e 3.
Soligenix (SNGX) anunció resultados preliminares de un estudio abierto que evalúa el tratamiento prolongado con HyBryte™ para el linfoma cutáneo de células T (CTCL) en estadio temprano. El estudio, respaldado por una subvención de la FDA de 2,6 millones de dólares, muestra resultados prometedores, con más del 70% de los pacientes elegibles (5 de 6) logrando 'Éxito del Tratamiento' - definido como una mejora de ≥50% en la puntuación mCAILS.
De los nueve pacientes inscritos tratados durante un máximo de 54 semanas, tres lograron el Éxito del Tratamiento en 12 semanas, con dos alcanzando la respuesta completa para la semana 18. Dos pacientes comenzaron recientemente el estudio, mientras que dos se retiraron por razones logísticas, con uno mostrando >30% de mejora en la semana 18. El tratamiento parece ser seguro y bien tolerado por todos los pacientes.
El estudio (RW-HPN-MF-01) tiene como objetivo inscribir a aproximadamente 20 pacientes en EE. UU. durante un máximo de 12 meses de dosificación dos veces por semana, con una posible transición a uso domiciliario. Esta investigación amplía los resultados positivos de los ensayos clínicos de Fase 2 y 3 anteriores.
Soligenix (SNGX)는 초기 단계 피부 T 세포 림프종(CTCL)에 대한 HyBryte™ 장기 치료를 평가하는 개방형 연구의 중간 결과를 발표했습니다. 이 연구는 260만 달러의 FDA 보조금으로 지원되었으며, 70% 이상의 적격 환자(6명 중 5명)가 mCAILS 점수에서 50% 이상의 개선을 정의한 '치료 성공'을 달성한 것으로 나타났습니다.
54주 동안 치료를 받은 9명의 등록 환자 중 3명이 12주 이내에 치료 성공을 이루었고, 2명은 18주 차에 완전 반응에 도달했습니다. 최근 두 환자가 연구를 시작했으며, 두 환자는 물류 문제로 탈락했고, 그중 한 환자는 18주 차에 30% 이상의 개선을 보였습니다. 이 치료는 모든 환자에게 안전하고 잘 견딜 수 있는 것으로 보입니다.
이 연구(RW-HPN-MF-01)는 최대 12개월 동안 주 2회 투약을 위해 약 20명의 미국 환자를 등록할 계획이며, 가정 자체 사용으로의 전환 가능성이 있습니다. 이 연구는 이전의 긍정적인 2상 및 3상 임상 시험 결과를 확장합니다.
Soligenix (SNGX) a annoncé les résultats préliminaires d'une étude ouverte évaluant le traitement prolongé avec HyBryte™ pour le lymphome cutané à cellules T (CTCL) à un stade précoce. L'étude, soutenue par une subvention de 2,6 millions de dollars de la FDA, montre des résultats prometteurs avec plus de 70 % des patients éligibles (5 sur 6) atteignant le 'Succès du Traitement' - défini comme une amélioration ≥50 % du score mCAILS.
Parmi les neuf patients inscrits traités jusqu'à 54 semaines, trois ont atteint le Succès du Traitement en 12 semaines, dont deux ont atteint une réponse complète à la semaine 18. Deux patients ont récemment commencé l'étude, tandis que deux se sont retirés pour des raisons logistiques, l'un montrant une amélioration de >30 % à la semaine 18. Le traitement semble sûr et bien toléré chez tous les patients.
L'étude (RW-HPN-MF-01) vise à recruter environ 20 patients aux États-Unis pour une durée allant jusqu'à 12 mois de dosage deux fois par semaine, avec une éventuelle transition vers une utilisation à domicile. Cette recherche prolonge les résultats positifs des essais cliniques précédents de Phase 2 et 3.
Soligenix (SNGX) hat vorläufige Ergebnisse aus einer offenen Studie vorgestellt, die die verlängerte Behandlung mit HyBryte™ bei frühzeitigen kutanen T-Zell-Lymphomen (CTCL) bewertet. Die Studie, unterstützt durch einen FDA-Zuschuss von 2,6 Millionen Dollar, zeigt vielversprechende Ergebnisse, da über 70% der geeigneten Patienten (5 von 6) den 'Behandlungserfolg' erreicht haben – definiert als ≥50% Verbesserung im mCAILS-Score.
Von den neun eingeschriebenen Patienten, die bis zu 54 Wochen behandelt wurden, erreichten drei innerhalb von 12 Wochen Behandlungserfolg, wobei zwei bis zur 18. Woche eine vollständige Remission erreichten. Zwei Patienten haben kürzlich an der Studie teilgenommen, während zwei aus logistischen Gründen ausgeschieden sind, wobei einer eine Verbesserung von über 30% in der 18. Woche zeigte. Die Behandlung scheint bei allen Patienten sicher und gut verträglich zu sein.
Die Studie (RW-HPN-MF-01) zielt darauf ab, etwa 20 US-Patienten für bis zu 12 Monate mit einer zweimal wöchentlichen Dosierung zu rekrutieren, mit der Möglichkeit einer Umstellung auf die Anwendung zu Hause. Diese Forschung erweitert die vorherigen positiven Ergebnisse der klinischen Studien der Phasen 2 und 3.
- 70% success rate (5 of 6 eligible patients) in treatment response
- Two patients achieved complete response by week 18
- Treatment demonstrated safety and tolerability across all patients
- Study supported by $2.6M FDA grant, indicating regulatory interest
- Two patients dropped out of the study (though for non-treatment related reasons)
- Small current sample size (9 patients) limits statistical significance
Insights
The interim update on HyBryte™'s extended treatment study reveals compelling efficacy data in CTCL treatment. With a 70% success rate (5 out of 6 evaluable patients) achieving the primary endpoint of ≥50% improvement in mCAILS scores and two complete responses by week 18, the data suggests superior efficacy compared to current standard treatments. The safety profile remains favorable, which is important for chronic treatment of this orphan disease.
The study's real-world treatment setting and potential for home use could significantly improve patient accessibility and compliance. The
The expansion to 12-month treatment duration addresses a critical clinical need for sustained therapy options in CTCL, where current treatments often show long-term efficacy or significant side effects.
This positive interim data strengthens HyBryte™'s commercial potential in the CTCL market. The therapy's demonstrated efficacy in an extended treatment setting, coupled with its favorable safety profile, positions it competitively against existing treatments. For context, the global CTCL therapeutics market is projected to grow significantly and novel treatments with superior efficacy profiles can capture substantial market share.
The FDA's financial backing through the Orphan Products Development Grant not only provides critical non-dilutive funding but also enhances the probability of regulatory approval. For a micro-cap company like Soligenix, this external validation could attract potential partnerships or additional investment interest. The potential for home-use administration could significantly expand market penetration and improve the therapy's commercial viability.
Study Supported by
"The complete response rate, consistent treatment response and safety profile across multiple clinical studies to date with HyBryte™ has been exciting to see," noted Dr. Kim, Principal Investigator of the IIS and Lead Investigator of the FLASH2 study. "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
"We are pleased with these recent study results and that the FDA is continuing to financially support the HyBryte™ program, 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 treatment options. 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. 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
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 (
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
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,
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 FLASH2 study 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
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
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
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 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/hybryte-expanded-treatment-continues-to-demonstrate-positive-outcomes-in-early-stage-cutaneous-t-cell-lymphoma-302350395.html
SOURCE SOLIGENIX, INC.
FAQ
What are the interim results of SNGX's HyBryte extended treatment study for CTCL?
How many patients are enrolled in SNGX's current HyBryte CTCL study?
What is the dosing schedule for HyBryte in SNGX's extended treatment study?
How is Treatment Success defined in SNGX's HyBryte CTCL study?
What is the funding source for SNGX's HyBryte extended treatment study?
