Soligenix Stock Rockets On Early Stage Lymphoma Data

Soligenix announces positive interim results from an investigator-initiated study evaluating extended HyBryte™ treatment for up to 12 months in early-stage cutaneous T-cell lymphoma (CTCL) patients.

Key points:

  • 75% of evaluable patients achieved “Treatment Success” with HyBryte™ therapy, defined as ≥50% improvement in cumulative mCAILS score.
  • The study, supported by a $2.6 million FDA grant, is evaluating extended treatment periods of up to 12 months in a real-world setting.
  • HyBryte™ appears to be safe and well-tolerated, with no treatment-related adverse events reported to date.

Market estimate: CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, with about 3,200 and 3,800 new cases annually in these regions, respectively.

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Soligenix, Inc. (Nasdaq: SNGX) has released an interim update on its open-label, investigator-initiated study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL).

In response, Soligenix’s stock price rocketed by over 270% Wednesday. Thursday, the drugmaker’s shares are up another 24% in pre-market trading.

Promising Early Results

Of the six patients enrolled so far, four have completed at least 12 weeks of therapy. Among these, 75% (3 out of 4) have achieved “Treatment Success,” defined as a 50% or greater improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to baseline. Two of these successes occurred within the first 12 weeks of treatment, while the third was observed at 18 weeks.

Extended Treatment Benefits

Dr. Christopher J. Schaber, President and CEO of Soligenix, expressed satisfaction with the initial results, noting that “continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients.”

This study builds on the positive results from previous Phase 2 and 3 clinical trials of HyBryte™.

Safety Profile

Importantly, HyBryte™ appears to be safe and well-tolerated in all patients, with no treatment-related adverse events reported to date.

This safety profile is particularly significant given the limited treatment options available for early-stage CTCL patients.

Future Outlook

The company plans to initiate a confirmatory Phase 3 replication study later this year. Dr. Kim, the Principal Investigator, emphasized the importance of this research, stating, “With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments.”

Takeaway

These interim results provide encouraging evidence for the potential of extended HyBryte™ treatment in early-stage CTCL.

If validated in additional studies, the biotech’s shares should continue to outperform the broader market.

Lymphoma.

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