Soligenix is nearing the release of its topline data from its SGX301 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, which are expected during the first quarter of 2020. Results from that trial may deliver the company’s first near-term potential catalyst from its Phase 3 clinical study, evaluating the benefits of SGX301 in patients with cutaneous T-cell lymphoma (CTCL).
Interim updates have been encouraging, supported by a company announcement in October 2018 stating that they received a positive recommendation from the independent Data Monitoring Committee (DMC), following interim efficacy analysis, to continue enrollment and to include an additional approximate 40 patients into the trial to maintain the high statistical power of 90% for the trial’s primary endpoint. The update may have provided a “read between the lines” moment, noting that if the DMC did not like the interim data they would have likely stopped the trial to protect patients, time, and resources. But, that was not the case.
As the results from the first of two late-stage trials get set to release data in 2020, we reached out to Soligenix CEO, Dr. Chris Schaber to get his take on the potentially transformative events that are taking shape in the next 4-7 months.
SMG: Soligenix is nearing the release of two potential major catalysts that can change the trajectory of the company. And, these are expected within the next 4-7 months. Knowing that interim data suggests that success may be imminent, what is the company doing today to set up for what may be a substantial 2020?
CS: Priority number one is the continued quality execution of our two clinical trials. We cannot take our eye off the ball, so to speak. There is still a considerable amount of internal work going on in verifying all patient data at the clinical study sites, having that data entered into each study’s database and making sure we are confident in its accuracy and completeness before locking that database and breaking the study blind at the appropriate time. However, in parallel with this important exercise, there is also an important focus on business development and identifying potential partner(s), which is being led by our Vice President of Business Development and Strategic Planning. As you would expect, I can provide no guarantees when or if we will have a partnership deal in the not too distant future. What I can say, is that there is interest and that we are in number of confidential diligence discussions. I will also note that we continue to seriously evaluate the option of commercializing CTCL in the US, as we believe this highly specialized orphan disease is tailor-made for a small company like Soligenix to effectively commercialize. It is an exciting time for us on a number of fronts!
SMG: Although we led with a broader question, Soligenix published important news on Tuesday, telling the markets that you have reached full enrollment for your FLASH trial targeting treatment of CTCL. That was an important accomplishment and one that sets the stage for your near-term topline data readout. Can you comment on what is forthcoming based on this news?
CS: Yes, we announced on Tuesday that we have completed patient enrollment in our Phase 3 FLASH study for SGX301 (synthetic hypericin) in the treatment of CTCL. Per design, the study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent (DMC. Now, with enrollment completed, we expect that top-line results will get released in the first quarter of 2020. There are a couple of points that stand out with this drug, as well.
We are especially excited about the drugs prospects with SGX301 being a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied as an ointment to the cancerous skin lesions and activated using a brief, safe, fluorescent light treatment. We believe that this drug will minimize the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on exposure to ultraviolet A and B light. Also, as I noted in our press release, we have invested a significant amount of theCompany’s resources into the CTCL development program and continue to positively position this fast-tracked program for approval. If formally approved, we believe SGX301 has the potential to be a valuable therapy in the front-line treatment of early stage CTCL, which is an orphan disease and area of unmet medical need.
SMG: The trial is highly powered by design as well. Did the positive results from the Phase 2 study play a significant role in that design?
CS: Certainly. Based on the positive results demonstrated in the Phase 2 study of SGX301, the design of the Phase 3 trial was constructed as a highly powered, double-blind, randomized, placebo-controlled, multicenter trial. As we noted in the release on Tuesday, the primary efficacy endpoint is assessed as the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a successful response of the treated lesions at the end of Cycle 1 (Week 8) compared to baseline. A successful treatment response is defined as a 50% or greater reduction of the three index lesions treated as determined by the cumulative Composite Assessment of Index Lesion Severity (CAILS) scoring system. Other secondary measures, including treatment response (including duration), degree of improvement, time to relapse and safety, are further determined by data collected throughout the follow-on open-label portions of the trial in Cycle 2 (index lesions treated in all patients) and Cycle 3 (all lesions treated in all patients), as well as the six-month follow-up period. We think we are in a great position to advance this drug based on what we saw during the Phase 2 study and from the positive recommendation received from the DMC during the Phase 3 interim analysis.
SMG: Soligenix appears to be unique in that it has a very low valuation for a company with two active Phase 3 assets nearing topline data read outs. Is the mix of government funding and disciplined use of cash the formula that makes Soligenix potentially stronger than peers that are nearing completion of Phase 3 trials?
CS: Correct. I believe it is a combination of our hands-on approach to clinical trial conduct and the level of success we have had to date in obtaining non-dilutive funding through government grant and contract awards, has potentially allowed us to manage cash burn more effectively than other late clinical-stage biotech companies. It has also afforded us the opportunity to build out a more robust rare disease pipeline than you would typically see for a company our size, providing multiple shots on goal to mitigate risk, as is apparent from the data read-outs fast approaching in two Phase 3 clinical trials.
SMG: Insiders recently purchased stock in what appears to have been a very tight window of open market opportunity. With the data from both Phase 3 trials blinded to all, were there some indicators that might have triggered the anxiousness to purchase additional shares in Soligenix?
CS: As you would imagine, given all we have going on internally, our legal counsel is very strict on insider buying, so the windows always seem a bit tight to me. I have been waiting for an opportunity to buy, so when the window opened for a short period this month, I bought. Both I and the Board have periodically bought on the open market as well as participated in financings over the years, and I suspect we will continue to do so. For me personally, I can confidently say, I will continue to do so when the opportunity presents itself. Ideally, it will before Phase 3 data read …
SMG: Both your SGX301 and SGX942 are targeting certain unmet medical needs. But, there is speculation that other significant markets may be addressable with these drugs, maybe even through an off-label prescription. Is there some truth to that speculation and how difficult would it be to prove effectiveness in treating Irritable Bowel Syndrome (IBS-D) with dusquetide (SGX942)?
CS: We will only promote what is in our approved labeling for SGX301 and SGX942, period. Now, if you are asking if there is the potential for label expansion with other disease indications? The answer is absolutely! With SGX301 (synthetic hypericin), in addition to CTCL, we have demonstrated in a small Phase 2 study some promising preliminary results in psoriasis. Psoriasis is a substantially larger market than CTCL and remains on our development radar for the future. With SGX942 (dusquetide), where we are currently pursuing oral mucositis in patients receiving chemo-radiation for their head and neck cancer, there are opportunities for continued development in other solid tumor cancers that are also treated with radiation and/or chemotherapy, such as in best cancer, as well as in patients with certain blood cancers. In addition, there is significant potential in other acute GI inflammatory diseases, like IBS, as well as in emerging infectious diseases, where we have demonstrated some positive preliminary results in animal models of infectious disease and currently have a government funded preclinical program looking at dusquetide, or SGX943, in this area.
BUT, not to state the obvious, our first priority is to build momentum through potential success in our two pivotal Phase 3 studies in CTCL and oral mucositis in head and neck cancer. It all starts from there! And, again, having reached full enrollment in the CTCL trial sets us up well heading into the next quarter. That news serves as a special moment for Soligenix and as a viable means to build substantial shareholder value.
For Soligenix, the first quarter of 2020 may provide the first of two transformative moments in the history of Soligenix. Based on analysts models, if the data from the SGX301 and SGX942 trial come in positive, Soligenix may become well-positioned to capitalize on at least two drugs that can combine to bring more than $500 million in annual revenues. And, that revenue is exclusive of the potential from the vaccine programs that can also add considerable value after their respective and anticipated approvals.
Also, with each of the drugs targeting unmet medical needs, those that cover Soligenix believe that there may be opportunity for partnerships, licensing deals, or collaborative agreements. Based on public information, the company may be ripe for investment consideration.
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