Following its successful Phase 3 clinical trial evaluating HyBryte (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma (CTCL), Soligenix is preparing to file a New Drug Application (NDA) with the FDA. HyBryte™ will potentially be a first-in-class treatment for CTCL, a rare skin cancer.

The company’s Public Health Solutions business segment is also making strong inroads, as it advances a heat stable vaccine platform that has the potential to prevent and manage future pandemics.

High potential for HyBryte™

HyBryte™ (synthetic hypericin) has consistently demonstrated strong efficacy in clinical trials, and the company’s Phase 3 trial was recently published in JAMA Dermatology.  Soligenix plans to commercialize HyBryte™ in the United States (U.S.) in a specialized market with a sound referral base, as well as low barriers to access, a finely honed ability to reach patients and high likelihood of reimbursement.

Key oncology and dermatology opinion leaders who currently provide diagnosis and treatment for CTCL patients, participated in the successful Phase 3 trial and will be used as the primary support for the NDA submission this quarter.  The Company also collaborates closely with key patient advocacy organizations, like the Cutaneous Lymphoma Foundation, that will aid with education and outreach.

Recently, the FDA Awarded a $2.6 Million Orphan Products Development Grant for Expanded Study of HyBryte™ in the Treatment of CTCL, which will serve to embark on potential home-use of the therapy.

CTCL affects over 40,000 patients worldwide and has no cure; median survival drops to only 2.5 years when the disease is in a more advanced stage. The condition can be difficult to diagnose, and in its early stages is often mistaken for eczema or skin rashes.

The global CTCL market was estimated at $1.6 billion in 2021 and is expected to grow to about $3.5 billion by 2030 with a compounded annual growth rate nearing 10 percent. Soligenix reports a U.S. target market valued at about $90 million, which the article indicates is a modest estimation in terms of total addressable market.

Soligenix has also received FDA clearance to commence a Phase 2 study for the use of synthetic hypericin to combat psoriasis and other potential indications.  The Phase 2 study in mild-to-moderate psoriasis is expected to open to enroll patients in December.

Serving major public health needs

Soligenix’s Public Health Solutions business segment is advancing a heat stable vaccine platform that targets ricin poisoning, Covid-19 and some of the world’s most deadly viral threats.

The ThermoVax^®technology platform has been funded to date by government grants and contracts, and centers around heat-stabilizing vaccines. These vaccines only require water to be added prior to use and can be stored for at least 12 months at 40 degrees Celsius, compared with the vast majority of vaccines that require strict cold-chain storage at temperatures of -60 degrees Celsius or lower.

Potential vaccine candidates being developed by Soligenix include RiVax^®, a ricin toxin vaccine, a Marburg and Ebola filovirus vaccine, and a Covid-19 vaccine, CiVax™, each of which has generated strong and consistent results. Presently, the National Institutes of Health (NIH) ranks both the Ebola and Marburg filoviruses as category A priority pathogens, and Ebola, Marburg, ricin and Covid are all in the USDA’s top 20 list of biological agents or toxins that could pose a severe health threat to both humans and animals.

The rapid rise and spread of the lethal Ebola virus across five districts in Uganda has alarmed scientists, and raised fears that the outbreak will not be easy to contain, further highlighting the critical need for effective vaccines.

Soligenix recently received a U.S. patent allowance for this vaccine platform, based on its ability to show success against some of the greatest viral threats across the globe. With strong interest from government and defense organizations alike, the vaccine platform is also an excellent fit for President Biden’s pandemic-preparedness initiative.

With multiple near-term catalysts in play, Soligenix remains committed to its mission of developing and commercializing products to treat rare diseases where there is an unmet medical need.

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