- A focus during the webinar was the investigator-initiated study currently being conducted at the University of Pennsylvania under the leadership of Dr. Ellen Kim.
- Interim results show that among the first eight patients who completed 18 weeks of treatment, 75% demonstrated a greater than 50% reduction in disease severity.
- Soligenix anticipates top-line results from the phase 3 trial in the second half of 2026.
In a recent webinar hosted by Allele Capital, Soligenix (NASDAQ: SNGX) executives Dr. Christopher Schaber and Dr. Christopher Pullion shared detailed updates on the company’s HyBryte(TM) (synthetic hypericin) clinical development (https://ibn.fm/dz7eO). The event offered an in-depth look at Soligenix’s ongoing confirmatory phase 3 trial for cutaneous T-cell lymphoma (“CTCL”), a rare non-Hodgkin’s lymphoma, and discussed promising data emerging from an investigator-initiated study conducted at the University of Pennsylvania. Soligenix, a late-stage biopharmaceutical company, is dedicated to developing and commercializing treatments for rare diseases and unmet medical needs, and HyBryte(TM) represents the company’s lead asset aimed at transforming the treatment landscape for CTCL.
HyBryte(TM) is a topical therapy activated by visible light that is applied directly to cancerous lesions on the skin, primarily targeting early-stage mycosis fungoides, which account for nearly 90% of CTCL cases. According to Dr. Schaber, Soligenix chairman, president and CEO, CTCL affects approximately 40,000 patients worldwide and is considered a chronic, relapsing disease that currently lacks an approved front-line treatment. HyBryte(TM) has the potential to fill that void, representing a significant commercial and therapeutic opportunity, with Soligenix estimating a market potential of more than $250 million globally and approximately $100 million in peak U.S. sales.
A central focus of the webinar was the investigator-initiated study currently being conducted at the University of Pennsylvania under the leadership of Dr. Ellen Kim, a recognized expert in CTCL and the lead principal investigator for both the original FLASH study and the ongoing phase 3 confirmatory FLASH2 trial. The study was designed to simulate real-world conditions by administering HyBryte(TM) twice weekly for up to one year, without treatment breaks, until patients reached disease clearance or a one-year mark. Using the Composite Assessment of Index Lesion Severity (“CAILS”) scoring system — a validated clinical tool and the gold standard in CTCL trials — researchers evaluated changes in lesion severity and response to treatment.
Interim results from the study were encouraging, reported Dr. Pullion, Soligenix medical director and CTCL program lead. Among the first eight patients who completed 18 weeks of treatment, 75% (six patients) demonstrated a greater than 50% reduction in disease severity, meeting the defined treatment response threshold. Moreover, 85% of patients across the study achieved similar reductions over time, and three patients reached complete remission with no visible lesions remaining. Importantly, the therapy exhibited an excellent safety profile with no serious adverse events, and participants showed strong compliance, further highlighting HyBryte(TM)’s potential as a well-tolerated, effective treatment for long-term disease management.
The findings from the study are particularly significant because of their close alignment with the ongoing phase 3 confirmatory FLASH2 trial. As Dr. Pullion explained, the phase 3 trial mirrors the treatment regimen used in the University of Pennsylvania study: the same dosage, the same scoring system and the same patient population. The primary endpoint in the phase 3 study is also measured at 18 weeks, the same time frame at which the earlier study showed strong results. Given the consistent methodology and encouraging parallels, Dr. Pullion expressed cautious optimism that the phase 3 trial will replicate the positive outcomes of earlier clinical trials and the investigator-initiated study.
Further comparisons between the clinical trials were outlined during the webinar. The original FLASH trial was the largest multicenter, double-blind, placebo-controlled study conducted for CTCL, and it met its primary endpoint of lesion improvement after treatment cycles that included treatment pauses. In contrast, the confirmatory phase 3 FLASH2 trial is designed to provide continuous therapy without breaks or pauses, which is expected to enhance efficacy, based on lessons learned from earlier trials. The current trial also benefits from participation by leading centers of excellence who are familiar with the therapy and motivated by the pressing need for new CTCL treatments.
Dr. Pullion emphasized that HyBryte(TM)’s ability to treat both patch and plaque lesions, often challenging for other topical therapies, is a major differentiator. Unlike some existing chemotherapeutic topical treatments that cause skin irritation or systemic side effects, HyBryte(TM) has shown minimal systemic absorption and a benign side effect profile. This positions it as a particularly attractive first-line option for CTCL patients, who often face lifelong treatment regimens and need therapies that are not only effective but also safe and tolerable over time.
As for what’s next, Schaber shared that Soligenix anticipates top-line results from the phase 3 FLASH2 trial in the second half of 2026. Meanwhile, an update on enrollment progress is expected later in 2025, with current trends suggesting enrollment is on track and may even be ahead of initial expectations. With data from the initial FLASH trial already published in JAMA Dermatology and the investigator-initiated study reinforcing the positive results, the company is entering a pivotal stage in development.
The webinar closed with both SNGX executives reiterating their commitment to addressing the critical unmet needs in CTCL. By building upon over a decade of research, clinical engagement and patient advocacy, Soligenix is positioning HyBryte(TM) not just as a novel therapeutic agent, but as a potential paradigm-shifting front-line treatment in the CTCL landscape.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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