Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma
Soligenix announced positive results from a comparative study evaluating HyBryte™ against Valchlor® for treating cutaneous T-cell lymphoma (CTCL). The open-label study involved 10 patients over a 12-week treatment period. Results showed that 60% of HyBryte™ patients achieved a 50% or greater improvement in their mCAILS score, compared to 20% for Valchlor®. HyBryte™ also demonstrated a more favorable safety profile, with no adverse events reported, while 60% of Valchlor® patients experienced therapy-related adverse events. The study supports previous Phase 2 and 3 findings and sets the stage for a Phase 3 placebo-controlled study later this year.
- 60% of HyBryte™ patients showed a 50% or greater improvement in mCAILS score.
- HyBryte™ had a more favorable safety profile with no adverse events reported.
- Supports positive data from previous Phase 3 FLASH study.
- HyBryte™ demonstrated a rapid onset of action and benign safety profile.
- Small sample size limits statistical significance of the results.
- One Valchlor® patient had to withdraw due to a clinically significant allergic contact dermatitis.
HyBryte™ has shown promising results when compared to Valchlor® for the treatment of cutaneous T-cell lymphoma (CTCL). While the study had a small sample size (10 patients), the findings are noteworthy for several reasons. Firstly, HyBryte™ demonstrated a more robust treatment response, with
Moreover, the safety profile of HyBryte™ appears to be more favorable. The absence of adverse events related to HyBryte™ is a significant advantage, particularly in comparison to Valchlor®, where
From a regulatory perspective, these findings support further clinical trials and could expedite the process of bringing HyBryte™ to market. Investors should keep an eye on the upcoming Phase 3 study, which will provide more conclusive evidence regarding the drug's efficacy and safety.
The results of this study are highly relevant for oncologists specializing in CTCL. The modified Composite Assessment of Index Lesion Severity (mCAILS) score used in the study provides a reliable measure of lesion improvement, making the results particularly meaningful. The
It's also worth noting that the study's design accounted for baseline disparities between the groups, meaning HyBryte™ had patients with more extensive disease yet still outperformed Valchlor®. This is a critical point, as it suggests the drug's potential effectiveness across a broader patient population.
For practitioners, the favorable safety profile of HyBryte™ is a significant consideration. The lack of adverse reactions not only improves patient compliance but also reduces the burden of managing side effects, which can be particularly challenging in CTCL treatment.
The positive clinical results for HyBryte™ could have a substantial impact on Soligenix's stock performance. Successful clinical trials often lead to increased investor confidence and the comparative advantage over Valchlor® may position HyBryte™ as a preferred treatment option, potentially leading to higher market adoption and revenue growth.
However, it’s important for investors to consider the caveats. The study's small sample size limits the statistical significance of the results and further validation in larger Phase 3 trials will be necessary. Additionally, the competitive landscape for CTCL treatments is evolving and market dynamics could shift by the time HyBryte™ potentially receives FDA approval.
Investors should also be aware of the financial implications of funding further studies. While Phase 3 trials could lead to higher costs in the short term, the long-term financial benefits could be substantial if HyBryte™ continues to show superior efficacy and safety.
HyBryte™ demonstrates more rapid and robust treatment response compared to Valchlor® during 12-week treatment course
"Following the positive results from the previous Phase 2 and 3 studies where I previously participated in evaluating HyBryte™, we were excited to support Soligenix's effort to conduct a prospective comparative assessment of HyBryte™ versus Valchlor®," stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. "Despite the small study sample size and a randomization that lead to the HyBryte™ group having patients with more extensive disease, HyBryte™ performed well and the results are consistent with previous studies demonstrating its rapid onset of action and benign safety profile compared to one of the most widely prescribed approved drugs for early-stage CTCL. The positive effect this therapy can have for patients and the outstanding safety profile that HyBryte™ continues to demonstrate is very encouraging. We look forward to continuing to support Soligenix and participating in the upcoming Phase 3 placebo-controlled study."
"These results support the positive HyBryte™ data from the previously completed Phase 3 FLASH study and demonstrates that a relatively short treatment period with the drug can result in clinically meaningful outcomes," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This relatively rapid response to HyBryte™ therapy fits nicely into the treatment arsenal for CTCL and reinforces the relative safety of HyBryte™ in these patients compared to other therapies currently in use. We look forward to continuing to work with Dr. Poligone and all of our committed clinical investigators to initiate the confirmatory Phase 3 replication study (FLASH2) later this year."
The purpose of the study was to obtain preliminary comparative assessment of the safety and efficacy of Valchlor® versus HyBryte™ following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. At the end of the 12-week treatment period,
When comparing the tolerance of the topical therapies (i.e., reactions where the drug was applied to the skin) in this trial, it is notable that all patients tolerated HyBryte™ well and had no adverse events "Related" to the therapy. In contrast,
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
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
In addition, the FDA awarded an Orphan Products Development grant to support the 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
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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