HyBryte™ NDA Anticipated in H2 2022

New York, NY - (NewMediaWire) - July 26, 2022 - PCG Digital -- Late-stage biopharmaceutical company, Soligenix,Inc. (Nasdaq: SNGX), has completed the largest placebo controlled, randomized Phase 3 trial ever done in cutaneous T-cell lymphoma (CTCL) evaluating a novel topical treatment for early-stage CTCL and is preparing to submit a New Drug Application to the FDA to commercialize the product.

Cutaneous T-Cell lymphoma (CTCL) is a rare cancer that affects approximately 27,000 Americans. It has no cure and as a chronic condition must be managed by patients and their doctors over years, and sometimes decades. Today, most treatment options for CTCL are associated with significant safety concerns.

Soligenix’s treatment, HyBryte™,has been evaluated through Phase 1, 2 and 3 clinical trials and has been found to be safe and well-tolerated, and to significantly reduce CTCL lesion size. It also has an advantage over traditional phototherapy, which uses DNA-damaging ultraviolet (UV) light. HyBryte™ (topical synthetic hypericin), is applied directly to the cancerous skin lesions followed by activation with   safe, visible fluorescent light, so the risk of developing actinic skin damage and skin cancers is not a concern as it is with UV light. Short term side effects are also less common and milder than those usually found in traditional phototherapy.

It is an exciting time for CTCL patients, who may soon have access to a safer and more effective treatment option. We caught up with Dr. Richard Straube, Soligenix’s Chief Medical Officer, to find out more about HyBryte and the clinical journey to date.

Q: Can you tell us about HyBryte™and how it works?

A: HyBryte™is an ointment that delivers a drug called synthetic hypericin. We apply it topically on the skin on the lesions that are seen in CTCL. After the drug is absorbed by the cancer cells, which takes about 24 hours, we shine a fluorescent light on the affected areas. That in turn kills the cancer cells. 

Q: You’ve been involved in many clinical trials over the years. Is there anything about the HyBryte trials that stands out?

A: Certainly. The Phase 3 study undertaken by Soligenix to evaluate HyBryte™as a treatment is the largest placebo randomized controlled trials ever done in CTCL, and it showed that treatment with this combination of drug and light reduced the size of patients’ tumors in six weeks. Importantly, the study showed that if you continue therapy, the mounted response and the duration of response continue to dramatically increase. 

There are a number of new trials being done in CTCL, but the majority are evaluating treatments for late-stage disease. HyBryte™is targeted to the vast majority of patients who have early-stage disease and who are likely to stay early-stage for years to decades.

Watch the recent interviewwith Dr. Straube

Q: The results of the Phase 3 study have been published in JAMA Dermatology. What does this tell us about the study’s findings?

A: We are very pleased that the results of the study have been published in the JAMA Dermatologyjournal. It is one of the most prestigious journals in the field and the fact that they accepted this manuscript really underscores the importance of these results in treating CTCL patients. Additionally, the journal itself is targeted at those healthcare professionals that actually deal with these patients, and this article provides them with information directly, giving them the opportunity to discuss this treatment with their patients and make intelligent choices about whether or not this is the right therapy for them.

Q: Clinical trials are not possible without the patients involved. CTCL is a rare disease affecting approximately 27,000 Americans. How was Soligenix able to reach the patient population?

A: CTCL is an orphan disease and there are not a lot of patients out there. Finding these patients and making them aware of the trial was key in making the Phase 3 study possible. We’ve been very grateful to the Cutaneous Lymphoma Foundation (CLF) which reached out to its membership and provided information on the clinical trial, allowing patients to evaluate whether they were willing to participate. Involvement in a clinical trial like this is a huge commitment on the part of the patient. They knew that there was the potential that they would have absolutely no personal benefit from participating and yet they were willing to take part in a rigorous clinical trial in order to help determine whether HyBryte™ would become a real treatment option for other patients with this long-term cancer.

Q: How are CTCL experts responding to this potential treatment?

A: We’ve been really happy with the excitement of clinicians who have been involved in the study and also some that have just looked at the results. For many clinicians, HyBryte™will potentially be the first new treatment they have seen in the past two decades, making it an important option for their patients in the future, provided the drug receives FDA approval. 

Q: What’s next on the path to commercialization?

A: Soligenix is submitting a New Drug Application to the FDA later this year. We believe that the data we have is very solid and we look forward to presenting it and potentially having a promising new treatment to offer patients living with CTCL.

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