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Soligenix Completes Enrollment in its Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis
Final top-line results expected Q4 2020 PRINCETON, N.J., June 24, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage
About this update from Soligenix, Inc.
[{"type":"text","content":"Final top-line results expected Q4 2020\n\n\nPRINCETON, N.J., June 24, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has completed patient enrollment in its Phase 3 DOM-INNATE (\"Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity\") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients. The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee (DMC). With enrollment completed, top-line results are expected in the fourth quarter of 2020. \nSGX942 is a novel, first-in-class, Innate Defense Regulator (IDR) which both modulates inflammation and enhances anti-infective and tissue-healing pathways of the innate immune system. Study enrollment was temporarily extended as Soligenix assessed the potential impact of COVID-19 on the study (e.g., patient treatment compliance and completion of necessary assessments). With extra efforts by participating patients, physicians and clinical staff, the Company can now successfully report that the negative impact of the pandemic on the overall study was much less than initially anticipated. The study remains on-track to provide top-line results before the end of 2020. \n\"We are pleased to have completed enrollment and look forward to the top-line results in the fourth quarter, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"We continue to positively position this fast-tracked program for approval. With approximately $8 million in cash as of the end of the first quarter, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in the DOM-INNATE...