Positive Outcome in 75% of CTCL Patients Treated with HyBryte™ for 18 Weeks
Soligenix (SNGX) announced positive interim results from an FDA-funded study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). After 18 weeks of treatment, 75% of patients achieved Treatment Success, defined as ≥50% improvement in mCAILS score.
Of the eight evaluable patients through Week 18, four completed the 54-week treatment with an average maximum improvement of 85% in mCAILS score, three remain on treatment, and one dropped out due to logistical issues. The study, led by Dr. Ellen Kim at Penn Cutaneous Lymphoma Program, demonstrates HyBryte's™ rapid response compared to other CTCL therapies that typically take 6-12 months for meaningful results.
The ongoing open-label study aims to enroll approximately 20 patients, supported by an FDA Orphan Products Development Grant of up to $2.6 million. The results reinforce HyBryte's™ potential as a safe and fast-acting therapy for this rare cancer.
Soligenix (SNGX) ha annunciato risultati intermedi positivi da uno studio finanziato dalla FDA che valuta il trattamento prolungato con HyBryte™ per il linfoma cutaneo a cellule T (CTCL) in fase iniziale. Dopo 18 settimane di trattamento, il 75% dei pazienti ha raggiunto il Successo del Trattamento, definito come un miglioramento ≥50% nel punteggio mCAILS.
Dei otto pazienti valutabili fino alla settimana 18, quattro hanno completato il trattamento di 54 settimane con un miglioramento massimo medio del 85% nel punteggio mCAILS, tre sono ancora in trattamento e uno ha abbandonato a causa di problemi logistici. Lo studio, guidato dalla Dr.ssa Ellen Kim del Penn Cutaneous Lymphoma Program, dimostra la risposta rapida di HyBryte™ rispetto ad altre terapie per il CTCL che di solito richiedono 6-12 mesi per risultati significativi.
Lo studio in corso, in aperto, mira a reclutare circa 20 pazienti, supportato da un Grant per lo Sviluppo di Prodotti Orfani della FDA fino a 2,6 milioni di dollari. I risultati rafforzano il potenziale di HyBryte™ come terapia sicura e ad azione rapida per questo raro cancro.
Soligenix (SNGX) anunció resultados intermedios positivos de un estudio financiado por la FDA que evalúa el tratamiento prolongado con HyBryte™ para el linfoma cutáneo de células T (CTCL) en etapa temprana. Después de 18 semanas de tratamiento, el 75% de los pacientes logró el Éxito del Tratamiento, definido como una mejora ≥50% en la puntuación mCAILS.
De los ocho pacientes evaluables hasta la semana 18, cuatro completaron el tratamiento de 54 semanas con una mejora máxima promedio del 85% en la puntuación mCAILS, tres continúan en tratamiento y uno se retiró debido a problemas logísticos. El estudio, dirigido por la Dra. Ellen Kim en el Penn Cutaneous Lymphoma Program, demuestra la rápida respuesta de HyBryte™ en comparación con otras terapias para CTCL que normalmente requieren de 6 a 12 meses para obtener resultados significativos.
El estudio en curso, abierto, tiene como objetivo inscribir aproximadamente a 20 pacientes, apoyado por una subvención de Desarrollo de Productos Huérfanos de la FDA de hasta 2.6 millones de dólares. Los resultados refuerzan el potencial de HyBryte™ como una terapia segura y de acción rápida para este raro cáncer.
Soligenix (SNGX)는 초기 피부 T세포 림프종(CTCL)을 위한 HyBryte™의 장기 치료를 평가하는 FDA 자금 지원 연구에서 긍정적인 중간 결과를 발표했습니다. 치료 18주 후, 75%의 환자가 치료 성공을 달성했습니다, 이는 mCAILS 점수에서 ≥50% 개선으로 정의됩니다.
18주까지 평가 가능한 8명의 환자 중 4명이 54주 치료를 완료했으며 mCAILS 점수에서 평균 최대 85% 개선을 보였고, 3명은 치료를 계속하고 있으며, 1명은 물류 문제로 중단했습니다. 펜 주 피부 림프종 프로그램의 Ellen Kim 박사가 이끄는 이 연구는 HyBryte™의 빠른 반응을 보여주며, 일반적으로 의미 있는 결과를 얻기 위해 6-12개월이 걸리는 다른 CTCL 치료법과 비교됩니다.
현재 진행 중인 공개 연구는 약 20명의 환자를 모집할 계획이며, 최대 260만 달러의 FDA 고아 제품 개발 보조금으로 지원받고 있습니다. 결과는 이 드문 암에 대해 HyBryte™가 안전하고 빠르게 작용하는 치료법으로서의 잠재력을 강화합니다.
Soligenix (SNGX) a annoncé des résultats intermédiaires positifs d'une étude financée par la FDA évaluant le traitement prolongé avec HyBryte™ pour le lymphome cutané à cellules T (CTCL) à un stade précoce. Après 18 semaines de traitement, 75 % des patients ont atteint le Succès du Traitement, défini comme une amélioration ≥50 % du score mCAILS.
Parmi les huit patients évaluables jusqu'à la semaine 18, quatre ont terminé le traitement de 54 semaines avec une amélioration maximale moyenne de 85 % du score mCAILS, trois restent en traitement et un a abandonné en raison de problèmes logistiques. L'étude, dirigée par le Dr Ellen Kim du Penn Cutaneous Lymphoma Program, démontre la réponse rapide de HyBryte™ par rapport à d'autres thérapies CTCL qui nécessitent généralement 6 à 12 mois pour des résultats significatifs.
L'étude ouverte en cours vise à recruter environ 20 patients, soutenue par une subvention de la FDA pour le développement de produits orphelins allant jusqu'à 2,6 millions de dollars. Les résultats renforcent le potentiel de HyBryte™ en tant que thérapie sûre et à action rapide pour ce cancer rare.
Soligenix (SNGX) gab positive Zwischenresultate aus einer von der FDA finanzierten Studie bekannt, die die verlängerte Behandlung mit HyBryte™ bei frühzeitigem kutanem T-Zell-Lymphom (CTCL) bewertet. Nach 18 Wochen Behandlung erreichten 75% der Patienten den Behandlungserfolg, definiert als eine Verbesserung von ≥50% im mCAILS-Score.
Von den acht bis zur Woche 18 bewertbaren Patienten schlossen vier die 54-wöchige Behandlung mit einer durchschnittlichen maximalen Verbesserung von 85% im mCAILS-Score ab, drei bleiben in Behandlung und einer brach aufgrund logistischer Probleme ab. Die Studie, geleitet von Dr. Ellen Kim am Penn Cutaneous Lymphoma Program, zeigt die schnelle Reaktion von HyBryte™ im Vergleich zu anderen CTCL-Therapien, die in der Regel 6-12 Monate für signifikante Ergebnisse benötigen.
Die laufende offene Studie zielt darauf ab, etwa 20 Patienten zu rekrutieren, unterstützt durch einen FDA-Zuschuss für die Entwicklung von Waisenkindprodukten von bis zu 2,6 Millionen Dollar. Die Ergebnisse stärken das Potenzial von HyBryte™ als sichere und schnell wirkende Therapie für diesen seltenen Krebs.
- 75% success rate in CTCL treatment after 18 weeks
- 85% average maximum improvement in mCAILS score for completed patients
- Rapid response time (18 weeks) compared to 6-12 months for other therapies
- FDA grant funding of $2.6 million supporting the study
- Strong safety profile with good tolerability
- One patient (12.5%) dropped out of the study
- Small patient sample size (only 8 evaluable patients)
- Study still ongoing and results are interim
Insights
These interim results from the FDA-funded investigator-initiated study represent significant clinical validation for HyBryte™ in early-stage CTCL. The 75% treatment success rate at 18 weeks is particularly impressive and consistent with previous trials, establishing a clear pattern of efficacy. What stands out is the rapid response time - while competing CTCL therapies typically require 6-12 months to show meaningful improvement, HyBryte™ demonstrates efficacy within 18 weeks.
The
The favorable safety profile consistently demonstrated across multiple studies is particularly important - current CTCL treatments often involve steroids, chemotherapeutics, or UV light, all of which carry significant side effects or cumulative toxicity concerns. The potential for eventual home use would represent a major quality-of-life improvement for patients requiring long-term management. While the sample size remains small (8 evaluable patients at this interim analysis), these results meaningfully reinforce previous findings and build confidence for the pivotal confirmatory Phase 3 FLASH2 study currently underway.
This positive interim data from the FDA-funded investigator-initiated study strengthens HyBryte™'s commercial case as Soligenix advances toward potential approval for CTCL treatment. The 75% treatment success rate at 18 weeks validates previous findings while highlighting a crucial competitive advantage - speed of response compared to existing therapies that may take 6-12 months to show improvement.
Several factors enhance the significance of these results: First, the FDA's financial support through a
For Soligenix, with its
Interim Results from FDA-Funded Study Reinforces HyBryte's™ Rapid Response and Strong Safety Profile
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
"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
"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
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
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FAQ
What percentage of CTCL patients showed success with HyBryte™ treatment in the SNGX study?
How much improvement did SNGX's HyBryte™ show in completed patients' mCAILS scores?
What is the timeline for HyBryte™ treatment response compared to other CTCL therapies?
How much FDA grant funding did SNGX receive for the HyBryte™ study?
