By Grant Zeng, CFA
Earlier this morning (Feb. 22, 2017), Soligenix (NASDAQ:SNGX) announced that its proprietary formulation of synthetic hypericin has been granted a European patent for the treatment of psoriasis.
The issued patent, EP 2571507, Formulations and methods of treatment of skin conditions, complements the method of treatment claims covered by the previously issued US patent 6001882, Photoactivated hypericin and the use thereof.
Synthetic hypericin is the active ingredient in Soligenix’s candidate SGX301, which completed a Phase II clinical study demonstrating significant improvement in both Cutaneous T-cell lymphoma (CTCL) and psoriasis. Soligenix is currently enrolling patients into a pivotal Phase III clinical trial of SGX301 for the treatment of CTCL.
Background of SGX301
In early September 2014, Soligenix entered into an asset purchase agreement with Hy Biopharma, Inc. Pursuant to the agreement, Soligenix acquired a novel orphan drug candidate, known as SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data.
In addition to CTCL, the acquired technology package also includes preclinical and clinical data supporting other potential indications for hypericin photodynamic therapy, such as psoriasis.
SGX301 for CTCL
Hy Biopharma conducted both Phase I and Phase II studies of hypericin. Topical hypericin was safe and well tolerated in a Phase I clinical study in healthy volunteers. In a Phase II, placebo-controlled, clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to topical hypericin treatment compared to only 8.3% receiving placebo (p < 0.04).
Based on data from the Phase I and II studies, Soligenix initiated the pivotal Phase III trial of SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL) in late 2015.
Soligenix is working with leading CTCL centers, as well as with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to conduct the pivotal Phase III clinical study of SGX301 in the treatment of CTCL.
NORD and CLF will assist the Company in educating patients and raising awareness of the Phase III clinical trial among patients who are eligible for participation.
The Phase III trial, referred to as the FLASH study (Fluorescent Light Activated Synthetic Hypericin), will be a multicenter, randomized, double-blind, placebo-controlled study that will enroll 120 evaluable subjects.
- The trial will consist of three treatment cycles, each of 8 weeks duration.
- Treatments will be administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8.
- In the first treatment cycle, approximately 80 patients will receive SGX301 and 40 will receive placebo treatment of their index lesions.
- In the second cycle, all patients will receive SGX301 treatment of their index lesions and in the third (open-label) cycle all patients will receive SGX301 treatment of all their lesions;
- Subjects will be followed for an additional 6 months after the completion of treatment;
- The primary clinical efficacy endpoint is treatment response assessed using the CAILS (Composite Assessment of Index Lesion Severity) score evaluating the three worst index lesions at the end of Cycle 1 (Week 8);
- Other secondary measures will assess treatment response (including duration), degree of improvement, time to relapse and safety.
Data from the Phase III trial are expected to be available by the end of 2017.
The Expansion to Psoriasis
In the published Phase II study: Journal of the American Academy of Dermatology (https://dx.doi.org/10.1016/j.jaad.2010.02.039), in patients with psoriasis, a statistically significant (p<0.02) improvement with topical hypericin treatment was experienced, whereas the placebo was ineffective: 54.6% vs. 0.0%, respectively.
Psoriasis is an autoimmune inflammatory disease that is similarly characterized by cutaneous accumulation of T-cell lymphocytes but without cancerous transformation. Psoriasis is a chronic, noncommunicable, painful skin condition for which there is no cure with great negative impact on patients' quality of life.
According to WHO, the prevalence of psoriasis is between 1.5% and 5% in developed countries, with some suggestions of incidence increasing with time. Psoriasis affects approximately 2% of the total population in the US.
SGX301 in CTCL has received orphan drug and fast track designations from the FDA as well as orphan designation from the European Medicines Agency (EMA) and promising innovative medicine designation from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
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