SNGX: Receives IND Clearance for Phase 2 Clinical Trial in Psoriasis…
NASDAQ:SNGX
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Business Update
Phase 2 Trial in Psoriasis to Initiate in 4Q22
In June 2022, Soligenix, Inc. (NASDAQ:SNGX) announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial in psoriasis. The trial, titled “Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis”, will be a randomized, double blind, placebo controlled study that will enroll up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2% to 30% of their body. Placebo or SGX302 (randomized 1:1) will be administered twice weekly for up to 18 weeks, with each treatment consisting of application of therapy followed approximately 24 hours later with visible light activation. The efficacy endpoints for the trial will include lesion clearance along with patient quality of life indices. We anticipate the trial initiating in the fourth quarter of 2022.
Psoriasis is a common, chronic, noncontagious, multisystem inflammatory condition that most commonly presents on the skin of the elbows, knees, scalp, back, and thighs. There are multiple types of psoriasis, with plaque psoriasis, being the most common and affecting 80-90% of all individuals with psoriasis. Plaque psoriasis involves the hyperproliferation of epidermal keratinocytes that results in red or white, scaly, and typically itchy skin lesions. In addition, approximately 20% of psoriasis patients suffer from psoriatic arthritis, an inflammatory joint disease associated with psoriasis (Zacharlae, 2003). There is no known cure for the disease, thus depending upon the severity of the condition and how responsive it is to treatment, some patients are on therapy for life.
While psoriasis itself is not life-threatening, there are several conditions that are associated with the disease, including cardiovascular disease (Shlyankevich et al., 2014) and hypertension (Armstrong et al., 2013). In addition, patients with psoriasis have an increased risk for a number of non-skin cancers, including cancer of the lung, upper gastrointestinal tract, urinary tract, liver, and pancreas (Richard et al., 2013).
Soligenix previously tested synthetic hypericin in a small Phase 1/2 trial involving 13 patients with psoriasis (Rook et al., 2010). Results showed that of the 11 evaluable patients, six responded to treatment with hypericin. There were no deaths or serious adverse events and the only reported adverse events were mild to moderate and included itching, burning, erythema, and pruritus at that application site.
HyBryte™ NDA Anticipated in 4Q22
Soligenix, Inc. (SNGX) previously completed a Phase 3 clinical trial of HyBryte™ (SGX301, synthetic hypericin) in patients with cutaneous T cell lymphoma (CTCL). The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial was a randomized, double blind, placebo controlled study that enrolled 169 patients with either Stage IA, IB, or IIA mycosis fungoides (the most common type of CTCL) (NCT02448381). The results of the trial were recently published in the Journal of the American Medical Association (JAMA) Dermatology (Kim et al., 2022).
The trial consisted of three treatment cycles, with each cycle lasting eight weeks. Each study subject had three target lesions treated during the trial. In Cycle 1, patients were randomized 2:1 (n=116 for SGX301; n=50 for placebo) to receive twice weekly treatment of either 0.25% SGX301 or placebo (an ointment with the same light exposure as for SGX301) for six weeks, with treatment response determined at the end of the eighth week. In Cycle 2, all subjects received 0.25% SGX301 on their target lesions, and for those that decided to continue in the trial there was a third treatment cycle where 0.25% SGX301 was applied to all of the patient’s lesions.
The results for Cycle 1 showed a statistically significant treatment response in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessed at 8 weeks with 16% of patients receiving SGX301 responding compared to only 4% receiving placebo responding (P=0.04).
In Cycle 2, a total of 155 patients received 0.25% SGX301 on their target lesions (110 receiving 12 weeks of SGX301 and 45 receiving six weeks of placebo treatment followed by six weeks of SGX301 treatment). The results of Cycle 2 showed that continued treatment out to 12 weeks resulted in increased efficacy as shown by a 40% responder rate (P<0.0001 compared to both placebo and six-week treatment data). Response rates further improved in Cycle 3 with 49% of patients electing to receive SGX301 for 18 weeks demonstrating a 50% or greater reduction in the combined CAILS. (P<0.0001 compared to the end of Cycle 1).
Importantly, after 12 weeks of treatment with HyBryte, there is a similar response on both patch (37% response; P=0.0009) and plaque (42% response; P<0.001) lesions when compared to Cycle 1 placebo lesion responses.
HyBryte is a safe and well tolerated CTCL treatment that shows positive effects in a relatively short period of time and has increasing efficacy with continued use. Since CTCL is a long-lasting condition, safety and tolerability are at the forefront of prescribing physicians concerns when treating patients, and many other CTCL therapies have a number of potential serious side effects, particularly with extended use. We believe the data that Soligenix has compiled for SGX301 in treating CTCL positions it as a promising front-line therapy for a large percentage of patients.
Soligenix is now in a position to submit an NDA to the U.S. FDA for HyBryte in the fourth quarter of 2022. HyBryte has received both Orphan Drug and Fast Track designations from the U.S. FDA as well as Orphan Drug designation from the European Medicines Agency (EMA).
The company is planning to commercialize HyBryte in the U.S. in lieu of seeking a commercialization partnership. Since the CTCL market is a specialized market, Soligenix can cost effectively market the drug with a launch cost of less than $10 million. This way, the company is able to keep 100% of the drug’s value. For overseas markets, we anticipate a commercial partnership and the company is currently in discussions with potential partners. Approval will be sought first in the U.S. followed by other key markets worldwide.
In July 2022, Soligenix announced that it has reached agreement with the U.S. FDA for an initial pediatric study (iPSP) plan for HyBryte™ for the treatment of CTCL. The iPSP stipulates that Soligenix intends to request a full waiver of pediatric studies in the submission of the NDA for HyBryte™. The agreement with the FDA on the iPSP is a regulatory requirement that must be met prior to submitting the NDA.
Financial Update
On August 12, 2022, Soligenix announced financial results for the second quarter of 2022. The company reported revenues of $0.2 million for the second quarter of 2022. The revenues are derived primarily from the company’s strategic partnership with SERB Pharmaceuticals and from government contracts and grants to support the development of RiVax® along with grants to support the development of SGX943, ThermoVax®, and CiVax®. R&D expenses for the second quarter of 2022 were $2.0 million, compared to $1.9 million for the second quarter of 2021. The increase was primarily due to increased expenses associated with the preparation of the upcoming HyBryte NDA filing. G&A expenses for the second quarter of 2022 were $1.4 million, compared to $1.1 million for the second quarter of 2021. The increase was primarily due to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc.
Soligenix exited the second quarter of 2022 with approximately $20.2 million in cash and cash equivalents. As of August 5, 2022, Soligenix had approximately 43.1 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 47.8 million.
Conclusion
We look forward to the filing of the NDA for HyBryte and the initiation of the psoriasis clinical trial for SGX302, both of which we anticipate in the fourth quarter of 2022. The current cash position, along with additional financial instruments available to the company, should provide funding into 2023. With no changes to our model our valuation remains at $4.00 per share.
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