FDA grants SGX301 a Type A meeting for the treatment of CTCL

FDA Holds Type A Conference to Discuss Design of Second Study of SGX301 (HyBryte) in Patients With Cutaneous T-Cell Lymphoma (CTCL) Following Positive Results from Phase 3 FLASH Trial (NCT02448381) allowed.1

The phase 3 FLASH study enrolled 169 patients, 166 of whom had evaluable stage IA, IB, or IIA CTCL and included 3 treatment cycles. She was treated twice weekly for the first 6 weeks and treatment response was determined at the end of her 8th week of each cycle.

Data revealed that SGX301 demonstrated statistically significant results across three treatment cycles and a six-month follow-up period, and that the product’s mechanism of action was not associated with DNA damage. This makes SGX301 a safer alternative compared to currently available treatments. All of these treatments are associated with serious and sometimes fatal adverse events, including the risk of melanoma and other malignancies, the risk of significant skin damage, and premature skin aging.

“In response to feedback from the FDA, Soligenix has submitted a confirmatory draft Phase 3 trial protocol that retains key aspects of the original Phase 3 trial,” said Soligenix president and chief executive officer. Dr. Christopher J. Shaver, Principal Investigator, said in a press release. “We look forward to discussing this protocol in detail with the FDA. We will provide further updates once we receive the minutes of the meeting or more clarity on next steps, which It is expected to be completed by the end of the year or by then.” June. “

To be included in the study, patients must have a clinical diagnosis of CTCL (mycosis fungoides) stage IA, stage IB, or stage IIA, have at least 3 evaluable discrete lesions, and be exposed to sunlight for the duration of the study must be withheld. .2

In the first double-blind treatment cycle, 116 patients received SGX301 (0.25% synthetic hypericin) and 50 received placebo.1 In this cycle, 16% of patients receiving SGX301 achieved at least 50% reduction in lesions at 8 weeks, compared to 4% of patients in the placebo group (P. = .04). In this first cycle, SGX301 was safe and well tolerated.

In Cycle 2, all patients received SGX301 for treatment of index lesions. A total of 110 patients received SGX301 for 12 weeks and 45 received 6 weeks of placebo followed by 6 weeks of SGX301 treatment. The response rate in the 12-week treatment group was 40% (P. < .0001 vs Cycle 1 placebo treatment rate. A statistically significant improvement was seen when comparing the 12-week treatment group with the 6-week treatment group (P. <.0001), indicating favorable outcomes with continued treatment. SGX301 remained safe and well-tolerated in this arm.

Additional analysis showed that SGX301 was equally effective in treating both plaques (42% response rate, P. <.0001 compared to placebo treatment in Cycle 1) and patch (37% response rate, P. = Cycle 1) .0009 compared to placebo treatment in CTCL lesions.

Finally, Cycle 3 focused on safety, with all patients having the option to receive SGX301 for treatment of all lesions. A total of 66% of patients chose to continue in this optional cycle study, and 49% had a positive treatment response (P. <.0001 compared to patients receiving placebo in Cycle 1). This cycle also showed that SGX301 was not systemically available, which is consistent with the general safety of this topical product observed to date, and the product's use to treat multiple lesions. Despite prolonged and increased use, SGX301 remained well tolerated.

Overall, these findings indicate that SGX301 may be the safest and most effective treatment for CTCL patients.

To further evaluate SGX301, researchers evaluated the product in a CTCL treatment suitability study using a commercially available Daavlin Series 7 visible light instrument.3 In this open-label study, nine patients were enrolled, treated with SGX301 for 8 weeks for cancerous lesions, and treatment response was assessed using the Composite Assessment of Index Lesion Severity (CAILS) score at 10 weeks. was done.

The goal of this test is to establish that any illuminator capable of producing visible light of suitable and consistent wavelength (500-650 nm) is suitable for use with the SGX301 and the recently developed more detailed was to extend the pharmacokinetic profile. Highly sensitive hypericin assay.

Although patients in this study were selected to have a broader spectrum of disease consistent with commercial potential, the study results show a treatment response rate of 22% after eight weeks of twice-weekly SGX301 therapy. , summarizing the results of the FLASH study. Cumulative CAILS scores improved in all patients, with a mean improvement of 36.4% (range, 8%–100%). Looking at individual lesions, 7 of the 27 index lesions (25.9%) had at least a 50% improvement in the CAILS score, and 4 of the 27 index lesions (14.8%) showed complete improvement after at least 8 weeks of treatment. Canceled. Systemic exposure and cardiac output measurements showed low and confined levels of systemic hypericin detected in the blood, with no observable effects on normal sinus rhythm. . These findings enhance the safety of SGX301.

“These results support a positive opinion.” [SGX301] Data from a FLASH study. A key corporate goal of this study was to use a final drug product manufactured by our proposed commercial contract manufacturer and activated using a commercially viable photonic device while previously in FLASH studies. Our goal was to reproduce the observed results,” Shaver added in the press release.I look forward to continuing to work with you [Brian Poligone, MD, PhD] And all of our dedicated clinical researchers [SGX301] This underserved orphan patient population will be made available. ”

1. Soligenix has announced the schedule of a Type A meeting with the US FDA to review a proposed study design for a Phase 2 Phase 3 trial evaluating HyBryte™ in the treatment of cutaneous T-cell lymphoma. news release. Soligenix, Inc. May 11, 2023. Accessed May 15, 2023. https://prn.to/4551VJh
2. Flash [fluorescent light activated synthetic hypericin] CLINICAL STUDIES: Topical SGX301 (a synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (mycosis fungoides). ClinicalTrials.gov. Updated April 15, 2022. Accessed May 15, 2023. https://clinicaltrials.gov/ct2/show/NCT02448381
3. Soligenix announces positive clinical results from suitability study of HyBryte™ in the treatment of cutaneous T-cell lymphoma. news release. Soligenix, Inc. May 4, 2023. Accessed May 15, 2023. https://bit.ly/3MscA9G

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