Oral mucositis, a debilitating side effect of cancer therapy with no FDA-approved treatment, continues to wreak havoc on patients undergoing cancer care, prompting an urgent need for effective interventions. Soligenix (NASDAQ: SNGX) is stepping forward with SGX942, a novel therapeutic aimed at alleviating this condition, with promising phase 3 data showing substantial improvements in the duration and severity of mucositis in head and neck cancer patients™.
Oral mucositis occurs when chemotherapy or radiation damages the mucous membranes of the mouth, leading to painful ulcers, inflammation and impaired oral function. It is exceptionally common among patients receiving head and neck cancer treatments: nearly all experience some degree of mucositis, with 62.5–94% developing severe cases that can interfere with essential activities such as eating and speaking (https://ibn.fm/jYTW2).
Severe oral mucositis (“SOM”) often necessitates hospitalization, opioid pain management and feeding tube placement, lowering quality of life substantially (https://ibn.fm/z8OeT). Because of these risks, effective treatment or prevention is critical to ensuring cancer therapies remain on schedule and patients maintain nutrition and comfort.
Statistics make the urgency palpable. A meta-analysis reveals that 94% of head and neck cancer patients undergoing radiotherapy develop oral mucositis, while 37% face severe cases (https://ibn.fm/DDsnI). One large institutional study reported that 98.6% of patients suffered mucositis, and 62.5% became severe, with nearly half struggling to swallow and over 50% requiring opiates by treatment end (https://ibn.fm/qJX2K).
Hallmarks of severe mucositis include weight loss, infections, hospitalization and delays in cancer treatment—all factors that can worsen patient outcomes. High-quality care must therefore include strategies to prevent or lessen mucositis to both preserve quality of life and optimize cancer therapy effectiveness.
Soligenix has taken on this challenge with SGX942 (dusquetide), an innate defense regulator aimed at reducing tissue inflammation, promoting healing and supporting immune response (https://ibn.fm/le0KI). The company’s phase 2 SGX942 clinical trial demonstrated remarkable results: a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). Secondary outcomes pointed to reduced infections, improved tumor resolution and enhanced survival among treated patients.
These outcomes prompted advancement to a phase 3 clinical trial (referred to as the DOM-INNATE study), which enrolled 268 patients, 266 of which were included in the intent-to-treat (“ITT”) population. The ITT population included all patients who received at least one dose of study drug (https://ibn.fm/JUUj8). According to study results, the primary endpoint of median duration of SOM did not achieve statistical significance (p≤0.05), although biologic efficacy was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group.
“Other secondary endpoints supported the biologic efficacy of dusquetide as well, including a statistically significant 50% reduction in the duration of SOM in the per-protocol (“PP”) population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial,” the company noted. “Both ITT and PP populations saw clinically meaningful changes. The time for which the patients experienced severe oral mucositis was reduced by approximately 50%. The changes in the PP population were statistically significant.”
With phase 3 results being consistent with phase 2 results, particularly in terms of the decrease in duration of oral mucositis, Soligenix is in the process of analyzing the combined phase 2 and 3 datasets to design a second pivotal phase 3 study. The company is also in the process of identifying potential partners to continue this development program.
Beyond SGX942, Soligenix is pursuing a broader strategy to tackle severe adverse effects of cancer therapy and dysregulated immune responses, using its innate defense regulatory platform to address mucosal injuries and inflammation across diverse patient populations.
Oral mucositis stands as one of the most distressing side effects of cancer treatment, disrupting therapy, diminishing quality of life and demanding costly supportive care. Through SGX942 and led by experienced clinical leadership, Soligenix is advancing a promising candidate to change that landscape.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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