(Nasdaq:SNGX) Offers New Hope and Research for Rare Form of Non-Hodgkins Lymphoma
While cutaneous T-cell lymphoma or CTCL—a rare form of non-Hodgkin’s lymphoma— currently has no FDA-approved first-line therapies, small-cap biotech Soligenix (Nasdaq: SNGX) is moving toward potential commercialization of HyBryte™ as a first-in-class treatment for the early stages of this disease that afflicts more than 25,000 patients in the United States.
HyBryte™, also known as SGX301 or synthetic hypericin, is a photodynamic therapy that uses safe visible light to treat CTCL. Unlike the traditional phototherapy of ultraviolet (UV) light for CTCL patients, HyBryte™ does not damage the skin, increase risk of skin cancer, cause wrinkling, sun damage, and/or freckles.
Dr. Ellen Kim, Medical Director of the Dermatology Clinic for the Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator (PI) for Soligenix’s positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in CTCL, presented key details of HyBryte’s™ efficacy and safety profile at the United States Cutaneous Lymphoma Consortium annual meeting.
In the recent interview, Dr. Kim noted that HyBryte™ is “really well tolerated. One of the limiting things we have with our current creams, ointments, and phototherapy, there are some short-term side effects, irritation, burning, sometimes blistering, and while they can be manageable, for some patients they can be really uncomfortable. HyBryte™ seems to have a very low incidence of short-term skin side effects, so probably patients will be able to stick with therapy and just feel more comfortable long-term using it, so that’s a major advantage. Then we did see good results, especially at the 16-week and 24-week time point.”
In comparison with other treatments, Dr. Kim noted that “HyBryte™ is as effective and has a better short-term, and possibly long-term, safety profile than current skin-directed therapies. It will be used both as a first-line therapy for my early-stage patients and for patients who can’t continue other therapies due to side effects or loss of response.”
HyBryte™ uses safe visible light as opposed to damaging UV light, which is the equivalent of sunlight. HyBryte™ has an advantage over phototherapy because its mechanism of action is distinct from UV phototherapy and is non-mutagenic, reducing the risk of skin damage and skin cancers, such as melanoma.
Interestingly, HyBryte™ may be a great candidate for the at-home medical market, which helps patients adhere to treatment and stay on track with their health and is expected to exceed $20.4 billion by 2027. Dr. Kim noted that a visible light panel would be safer than an UV panel at home “so it could be very well suited to home use.”
In addition, phototherapy treats the entire skin surface area exposed to the light, whereas HyBryte™ can be used for selective treatment if desired.
“After participating in the FLASH study as the overall study PI, I’ve been impressed with the efficacy and tolerability of HyBryte™— any localized skin application side effects have been very mild and manageable compared to other current skin directed therapies,” Dr. Kim added. “This will be a valuable, safer option for our patients who must utilize multiple different skin directed therapies to manage their chronic CTCL over many years and sometimes decades.”
To learn more about HyBryte™, visit https://www.hybryte.com