Today, Soligenix Inc. (Nasdaq: SNGX) announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the design of a second, Phase 3 pivotal study evaluating HyBryte™ (hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer. This comes after the treatment successfully demonstrated statistically significant results in the first Phase 3 clinical trial. The Type A Meeting is the highest priority classification of meetings the FDA grants, and is a promising step forward in developing treatments for this rare cancer.
Soligenix is thrilled to announce that, in response to FDA feedback, they have submitted a confirmatory Phase 3 draft study protocol that preserves the key aspects of their first Phase 3 trial. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, expressed his excitement and hopes that the protocol will be discussed in detail with the FDA. Soligenix is aiming to provide an update on the status of the meeting before the end of June.
HyBryte™ (research name SGX301) is a revolutionary photodynamic therapy that uses visible light to safely activate a synthetic form of hypericin, a powerful photosensitizer applied directly to skin lesions. This groundbreaking treatment approach penetrates deeper into the skin than ultraviolet light and has the potential to treat skin disease, plaques, and lesions at a much greater depth, without the risk of secondary malignancies like melanoma associated with traditional phototherapy.
Published Phase 2 clinical studies in CTCL (Cutaneous T-cell Lymphoma) have shown that topical hypericin treatment resulted in a statistically significant improvement in patients, compared to the placebo group. HyBryte™ has gained numerous recognitions, including orphan drug and fast track designations from the FDA, as well as orphan designation from the EMA (European Medicines Agency).
The recently published Phase 3 FLASH trial enrolled a total of 169 patients with Stage IA, IB or IIA CTCL, of which 166 were evaluable. The trial consisted of three treatment cycles, which were administered twice weekly for the first 6 weeks and treatment response was assessed at the end of the 8th week.
In the first double-blind treatment cycle, patients were given either HyBryte™ or placebo treatment of their index lesions. The results were astounding, with 16% of the HyBryte™ group showing at least a 50% reduction in their lesions (measured using the CAILS score) compared to only 4% in the placebo group at 8 weeks (p=0.04). HyBryte™ treatment in the first cycle was also safe and well tolerated.
In the second open-label treatment cycle (Cycle 2), HyBryte™ treatment of index lesions demonstrated impressive results. Of the 155 patients evaluated, those who received 12 weeks of the treatment experienced a 40% response rate – a significant improvement (p<0.0001) over the 6-week placebo treatment group.
What’s more, HyBryte™ was found to be safe, well-tolerated, and equally effective in treating both plaque and patch lesions of CTCL – a breakthrough, given the difficulty in treating the latter in particular.
In a compassionate-use/safety cycle of the study, 66% of patients chose to receive HyBryte™ treatment of all their lesions. Of this subset, a whopping 49% saw a positive treatment response (p<0.0001 vs placebo in Cycle 1). Even with extended, increased use of HyBryte™, it continued to be well tolerated and found not to be systemically available. The results of this third cycle clearly show that HyBryte™ is an effective and safe treatment for multiple lesions.
HyBryte™ is an innovative and much needed treatment for CTCL, offering a much safer alternative to currently available treatments. Unlike other therapies, it is not associated with the risk of DNA damage, melanoma or other malignancies, nor the risk of significant skin damage or premature skin aging. This makes it a highly sought-after option for those suffering from CTCL, as the safety of the treatment is paramount.
In the three treatment cycles and six-month follow-up period, no evidence of potential safety issues has been found, with very limited systemic absorption, a non-mutagenic compound and a light source which is not carcinogenic. HyBryte™ is the safest available efficacious treatment for CTCL, offering hope to those suffering from this condition.
The National Cancer Institute and the FDA have both stepped in to support the development of HyBryte™, a promising new treatment for early-stage Cutaneous T-Cell Lymphoma (CTCL). The NCI provided $1R44CA210848-01A1 to Soligenix, Inc. for a Phase II SBIR grant to fund a Phase 3 CTCL clinical study.
Additionally, the FDA awarded a $2.6 million, 4-year Orphan Products Development grant to a prestigious academic institution that is a major contributor to the Phase 3 FLASH study. With such strong backing from the government, HyBryte™ is sure to revolutionize the treatment of CTCL, both in the home and in clinical settings.
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a frighteningly aggressive form of non-Hodgkin’s lymphoma, a cancer of the body’s white blood cells. Caused by an expansion of malignant T-cell lymphocytes, these cells migrate to the skin, forming various lesions that can range from patches to raised plaques and tumors.
Unfortunately, no cure exists for CTCL, with median survival ranging from twelve years in the early stages to a mere two and a half years once the disease has advanced. Treatment may cause lesions to regress, however they often return, either in the same area or in new locations.
Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin lymphoma that affects around 25,000 people in the United States each year. Approximately 3,000 new cases are diagnosed annually, making up around 4% of the total cases of non-Hodgkin lymphoma. CTCL is a serious and potentially life-threatening condition that requires careful monitoring and management.
About Soligenix, Inc.
Soligenix is a biopharmaceutical leader in developing and commercializing innovative treatments for rare diseases. Our Specialized BioTherapeutics business segment is currently advancing the potential commercialization of HyBryte™ (SGX301 or synthetic hypericin), a novel photodynamic therapy that utilizes safe visible light to treat cutaneous T-cell lymphoma (CTCL).
Following a successful Phase 3 study, regulatory approval is being sought and commercialization activities are underway in the U.S. We are also exploring the use of synthetic hypericin (SGX302) for psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders such as pediatric Crohn’s disease (SGX203).
Our Public Health Solutions business segment is actively developing innovative solutions for a range of infectious diseases. Our RiVax® vaccine candidate is designed to protect against ricin toxin, while SGX943 is a potential therapeutic for antibiotic-resistant and emerging infectious diseases.
Our heat stabilization platform technology, ThermoVax®, is also being used to develop vaccine programs for filoviruses such as Marburg and Ebola, as well as CiVax™, our COVID-19 vaccine candidate. To date, this segment has been generously supported with government grants and contracts from NIAID, DTRA, and BARDA.