Market Overview

Major Milestones for Soligenix Bring 2019 to a Strong Close


New York, New York--(Newsfile Corp. - December 11, 2019) - As the end of the year's fourth quarter comes to a close, CEO3in60 highlights how Soligenix (NASDAQ:SNGX) has achieved multiple milestones across the company's core focus areas. Two treatments in development to treat rare diseases and/or areas of unmet medical need are currently in Phase 3 studies. Additionally, the Public Health Solutions arm has grown to operate under a multi-million-dollar contract with the National Institutes of Health (NIH).

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Patient Enrollment Completed for SGX301 Phase 3 Study

At the beginning of the month, Soligenix reached a new milestone by completing patient enrollment for its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin), which is designed to treat cutaneous T-cell lymphoma (CTCL).

169 subjects successfully enrolled in the study, which had previously received positive interim analysis from an independent Data Monitoring Committee (DMC) in October 2018. The committee recommended to continue enrolling patients, having observed a beneficial drug effect and further recommended to increase the trial sample size of the study in order to maintain its 90% statistical power, a rigorous standard for the industry. Additionally, the DMC did not note any safety concerns associated with the use of SGX301.

With enrollment complete for this pivotal Phase 3 trial, top-line results are now expected in the first quarter of 2020. SGX301 is a priority program for Soligenix and this study will be used to support a marketing authorization or new drug filing with the US FDA.

More About the SGX301 Clinical Trial

SGX301 is a photodynamic therapy that treats cancerous skin lesions by applying a novel, first in class, synthetic hypericin topical ointment followed by activation of the drug with safe, visible fluorescent light. The treatment has the potential to be the first approved front line therapy for CTCL and is anticipated to minimize the risk of secondary malignancies associated with other photodynamic and chemo- therapies, many of which are currently not FDA approved.

The Phase 3 trial design includes three distinct cycles of treatment:

The first cycle is defined as treatment period for the primary endpoint in the trial. Cycle 1 is the randomized double-blind portion of the study with 2:1 SGX301: placebo randomization across 169 patients. The patients treat their 3 index lesions twice a week for 6 weeks, with escalating light exposure until a study defined maximum light exposure is reached. After a 2 week rest period, the size and characteristics of the 3 index lesions are assessed and the improvement in lesion scores for all 3 lesions are compared to the cumulative score for those same lesions at baseline. An improvement ≥50% is considered a successful response.

The second cycle of the study is an unblinded portion. All patients treat their 3 index lesions with SGX301, using the same procedure as in Cycle 1. The lesions are characterized at the end (week 8) of the cycle.

The third cycle of the study is also unblinded and is optional. In this cycle, patients can treat all their lesions with SGX301, using the same procedure as in Cycle 1.

Following Cycle 3 (or Cycle 2 if the patients don't opt into Cycle 3), a six-month follow-up is undertaken.

Phase 3 for SGX942

Another promising treatment under development is SGX942, which is now actively enrolling in a Phase 3 clinical trial, following a positive interim analysis that was conducted by a DMC in August of 2019. The study is enrolling 260 patients in the US and Europe. Patient enrollment is expected to finish in the first quarter of the new year and expect to receive the trial's top line results by the second quarter 2020.

SGX942 treats oral mucositis that develops in head and neck cancer patients receiving radiation and chemotherapy. oral mucositis is a side effect experienced by these cancer patients undergoing chemo-radiation. Oral mucositis inflames the mouth, throat, and GI tract, so severely that painful open ulcers develop that often times leaves patients unable to eat and drink. The symptoms can be so intense that patients may stop their cancer treatment just to gain temporary relief.

SGX942 is a short 4-minute IV-infusion given in conjunction with the radiation and chemotherapy treatment. The anticipated result is that theSGX942 will modulate or reduce the severe inflammation, while healing the mouth quicker and reducing the high infection rates often associated with oral mucositis.

Government Contracts in Public Health Initiatives

Soligenix also operates a Public Health Solutions business segment, which is presently funded entirely by the government. Currently, the company is operating under about $28 million in government grants and contracts, predominantly with the NIH. The lead program currently in development, is a heat stable ricin vaccine, RiVax®, to prevent lethal ricin poisoning.

These public health programs provide an offset to the company's overall cash burden, allowing Soligenix to manage its funds more effectively compared to other biotech companies.

Soligenix is proud to end the year with multiple promising trials in progress and looks forward to contributing even more to the medical community in 2020.

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