New York, NY – (NewMediaWire) – January 12, 2022 – PCG Digital — Soligenix, Inc. (SNGX), a US-based late-stage biopharmaceutical company, issued a corporate update this week with good news for their shareholders. Despite supply-chain delays in receiving the active pharmaceutical ingredient for SGX301, aka HyBryte, the company is still on track to file a new drug application with the FDA in the latter half of 2022.
HyBryte is an early-stage treatment for cutaneous T-cell lymphoma (CTCL), a condition that affects an estimated 20,000 patients in the United States. The condition is also prevalent in Europe and Asia. It is caused by the migration of malignant T-cells to the surface of the skin and manifests itself in lesions, tumors, and plaques.
Watch Dr. Christopher Schaber’s most recent corporate presentation HERE
HyBryte Clinical Results Have Been Consistently Positive
Clinical testing of HyBryte has yielded consistently positive results. It works by applying fluorescent light to synthetic hypericin. In December, a Phase 3 FLASH study showed a rapid treatment response in six weeks and sustained responses in twelve and eighteen weeks that produced significant improvement for half of the trial participants.
The trials have been so effective that Soligenix is now exploring a second formulation, SGX302, to treat psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept (PoC) 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 $40.58 billion by 2027.
Heat Stabilized Vaccine Development is On Track
In addition to the good news on SGX301 and SGX302, Soligenix also reported that their heat stable vaccine technology is showing positive results. Testing in non-human primates (NHP) have shown significant efficacy in their filovirus candidates that target Ebola, Sudan, Marburg, and Covid-19. A ricin toxin vaccine (RiVax®) also continues to show promise.
Heat stabilization solves a logistical problem that other vaccine developers have been challenged with. The existing Covid-19 vaccines from Moderna, Johnson and Johnson, and Pfizer all require shipping and storage at sub-zero temperatures. That makes them impractical for remote and technologically underdeveloped regions. Soligenix is solving that problem.
Compelling Value Proposition: Sooner Rather than Later
NDA filing to FDA l of HyBryte should increase share prices for Soligenix. According to a recent article by Zacks Research, a new drug approval can lead to a higher share price for the company receiving that approval. Soligenix is on the cusp of that now, and investors are already buying in. Shares for SNGX are currently trading near cash and if form holds the stock should react positively sooner rather than later. Those on the sidelines considering a position may want to pay attention to what’s in play.
Soligenix CEO Dr. Christopher J. Schaber told shareholders in his recent corporate updatethat the company remains energized by the promise of their development pipeline. He also reported that the company is continuing to evaluate potential strategic options, including partnerships, mergers, and acquisitions. Look for more on that as the year progresses.
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