New York, New York – June 7, 2022 (Newsfile Corp.) (Investorideas.com Newswire) PCG Digital – Rising to the challenge in 2022, late-stage biopharma company Soligenix (NASDAQ: SNGX) continues to move forward with developing and commercializing products to treat rare diseases where there is an unmet medical need.
(Rising to the challenges of rare disease treatment)
At the forefront of the company’s pipeline is HyBryte(TM), a treatment for early-stage cutaneous T-cell lymphoma (CTCL), a condition that affects over 25,000 patients in the United States. The condition, which is also prevalent in Europe and Asia, is caused by the migration of malignant T-cells to the surface of the skin and manifests itself in painful lesions, tumors and plaques.
Clinical testing of HyBryte(TM) has yielded consistently positive results. It works by applying fluorescent light to topical synthetic hypericin, and in a Phase 3 study it showed a rapid treatment response in six weeks and sustained responses after twelve and eighteen weeks that produced significant improvement for half of the trial participants. Soligenix anticipates submitting a new drug application (NDA) to the FDA for HyBryte(TM) to treat CTCL in H2 2022.
The trials have been so effective that Soligenix is now exploring a second disease indication, with synthetic hypericin (SGX302), for the treatment of psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept and a Phase 2a clinical trial is being initiated later this year. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.
Reaching beyond the clinic
Physicians have expressed interest in recommending HyBryte to their patients following regulatory approval, but what about its applicability beyond the clinic? Soligenix has plans to develop HyBryte for home use within 12-18 months of receiving FDA approval, and is looking at expanding its use for other potential disease indications, such as psoriasis.
In a recent interview with the Cutaneous Lymphoma Foundation, CEO Susan Thornton explained the significance of the access a home device could provide for CTCL patients: “We know that we have people everywhere geographically, so access is really important and having a company dedicated to making sure patients have access is really, really critical as well.”
The U.S. home medical equipment market, which helps patients adhere to treatment and stay on track with their health, is expected to exceed $20.4 billion by 2027.
Soligenix continues to add value
With a cash runway of about $23 million, not including non-dilutive government funding, Soligenix is well funded to cross the finish line. To date, Soligenix has received $7.6 million in non-operating loss funding and continues to actively pursue non-dilutive funding to offset operating expenses and add value for shareholders. In addition, its management team continues to purchase shares of the company’s common stock on the open market, representing a significant alignment of interests.
Zack’s research recently issued an update outlining the Company’s value proposition and valuated the stock at $4.00 per share.
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