Press Release

Soligenix: Phase III Trial Success Offers New Hope to Those Living with Rare Disease

  • Annual Incidence of Cutaneous T-cell Lymphoma is Six New Cases in One Million in the United States
  • There is currently no FDA-approved first line treatment for CTCL
  • Soligenix has the most advanced drug candidate for CTCL: HyBryte
  • Soligenix has a cash runway of $29 million to fully fund marketing of its treatments

New York, NY – August 12, 2021 – PCG Digital –The uncertainty caused by the COVID-19 pandemic in 2020 meant that many elective medical procedures, including cancer screenings, were put on hold, allowing healthcare professionals to operate safely while prioritizing urgent care. The American Academy of Dermatology noted that patient appointments, including screenings and biopsies, decreased by more than 70% at the pandemic’s peak. Rare diseases, although exceedingly uncommon, are picked up at the type of routine appointments and screenings that have been avoided or postponed during the pandemic.

Approximately 3,000 new cases of a rare type of non-Hodgkin’s lymphoma – cutaneous T-cell lymphoma (CTCL) – are diagnosed in the United States each year, and around 20,000 Americans are currently living with the disease. Primary treatments for CTCL include skin-directed therapies which combine a topical steroid or other topical chemotherapeutic agent with ultraviolet (UV) light. However, beyond this potentially DNA-damaging UV exposure, there is currently no FDA-approved first line therapy for early stage CTCL.

More than 25 companies are now developing therapies for CTCL, with biopharmaceutical company, Soligenix (SNGX), leading the pack with the most advanced drug candidate having already demonstrated success in a pivotal Phase III clinical trial.

Soligenix’s HyBryte (SGX301 or synthetic hypericin) is a novel, first-in-class phototherapy that utilizes safe, fluorescent light to deliver less invasive photodynamic therapy for early-stage CTCL It has demonstrated safety, efficacy and tolerability in a successful Phase III study and has fewer and milder short-term side effects than traditional therapies.

Dr. Ellen Kim is 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 was the Lead Principal Investigator for Soligenix’s successful Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) study in CTCL.

Dr. Kim believes it’s time for first line treatments to be superseded by improved therapeutics.

HyBryte is as effective, and has better short term, and possibly long term, safety profile than current skin directed therapies. It is also effective for CTCL plaques which are traditionally more refractory to many skin-directed treatments. Given this, it will be used both as 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 has a definite advantage over phototherapy long term. Its mechanism of action is distinct from UV phototherapy and is non-mutagenic so the risk of developing actinic skin damage and skin cancers is lower. Short term side effects were also less common and milder than what we see in traditional phototherapy.”

Dr. Kim has presented a selection of high-level positive results from Soligenix’s Phase III FLASH study at conferences of the American Academy of Dermatology, the Society of Investigative Dermatology and the US Cutaneous Lymphoma Consortium. The full manuscript of the study is expected to be published in a peer reviewed medical journal later this year.

Soligenix’s unique funding model helps keep the company at the forefront of pharmaceutical research for public health, while allowing it the resources to strengthen other projects that are not government-funded. As of May 2021, Soligenix’s market cap was $51.3 million, with approximately $30 million in cash on hand. The company also has convertible debt funding with Pontifax Medison and an ATM sales issuance agreement with B. Riley Securities, which will allow Soligenix to fully fund future marketing activity for its treatments, if needed.

As Americans think about scheduling their end of summer skin screenings, Soligenix is working toward its New Drug Application (NDA) filing for FDA approval of HyBryte in the first half of 2022 and offering new hope to those living with CTCL.

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