U.S. stocks edge higher; solid earnings season continues
PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX) announced Thursday that its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease has achieved its objective of demonstrating biological efficacy. According to InvestingPro data, the micro-cap biotech company, currently valued at $4.08 million, maintains a strong balance sheet with more cash than debt, despite its stock declining 70% over the past year.
The open-label study showed SGX945’s effectiveness in treating oral ulcers associated with Behçet’s Disease, with results comparable to those seen in previous studies of apremilast (Otezla), which is currently approved for this indication.
After four weeks of treatment, SGX945 demonstrated a 40% improvement in the area under the curve (AUC) of oral ulcers relative to historical placebo data, compared to apremilast’s 37% improvement. Notably, SGX945’s benefits persisted during the four-week follow-up period even after treatment was discontinued.
Seven of eight patients reported perceived benefits from SGX945 treatment, including reduced duration and number of oral ulcers and decreased pain. One patient with a skin ulcer, typically difficult to treat, experienced resolution during the treatment period.
"The benefit of SGX945 was observed in 7 of 8 patients treated in this study, and many patients also commented on the reduced symptoms they experienced in the weeks following treatment as well," stated Dr. Gülen Hatemi, Professor of Medicine at Istanbul University and lead investigator in the study.
Unlike apremilast, which requires continuous administration and is associated with side effects including diarrhea (41% of patients), nausea (19%), and headache (14%), SGX945 was well-tolerated with no treatment-related adverse events reported.
Christopher J. Schaber, President and CEO of Soligenix, indicated the company plans to reformulate SGX945 to enable home-based treatment via subcutaneous injection and will design a follow-on placebo-controlled Phase 2 study. While InvestingPro analysis shows the company faces near-term profitability challenges with a weak Financial Health score of 1.36, analysts maintain optimistic price targets well above current trading levels. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro.
Behçet’s Disease affects approximately 18,000 people in the U.S., 50,000 in Europe, and up to 1 million people worldwide, according to the company’s press release statement. With volatile price movements and significant market potential, investors can access detailed valuation metrics and expert analysis through InvestingPro’s comprehensive financial toolkit.
In other recent news, Soligenix, Inc. has completed the transfer of manufacturing for its synthetic hypericin active ingredient from Europe to the United States. This transition was accomplished under a partnership with Sterling Pharma Solutions. The transfer involved optimizing and implementing a commercially viable, scalable production process. This process is crucial for the active ingredient used in HyBryte and SGX302. These topical formulations are being developed to treat cutaneous T-cell lymphoma (CTCL) and psoriasis. The company did not provide further details on the potential impact of this manufacturing shift. However, the move is part of Soligenix’s broader strategy to enhance its production capabilities. No additional updates on earnings or analyst ratings have been provided at this time.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.