VIEWS AND ANALYSIS, PHARMACY MARKET
Soligenix, Inc. | December 20, 2022
Soligenix, Inc. a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 2a study evaluating SGX302 in the treatment of mild-to-moderate psoriasis. Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease.
"We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound. Given our promising published results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix
The Phase 2a clinical trial will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In both Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.
Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected.
About Synthetic Hypericin
Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Synthetic hypericin or HyBryte™ was demonstrated in this study to be equally effective in treating both plaque and patch lesions in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL.
This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.
The Phase 3 FLASH trial enrolled a total of 169 patients with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte™ increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.
In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors. The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.
Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.
Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, our first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn's disease.
BUSINESS INSIGHTS, VIEWS AND ANALYSIS
Biodex Medical Systems | November 30, 2022
Mirion Technologies, Inc. announced that it has entered into a definitive agreement to sell the physical medicine assets of Biodex Medical Systems, Inc. to Salona Global Medical Device Corporation for $5 million in cash at closing and up to an additional $3 million in deferred cash payments. The deferred cash payments are contingent on the performance of the assets during the 12-month period following closing. The assets generated approximately $18 million in revenue with estimated gross margins of 30% during the most recent trailing twelve-month period.
“Divesting the physical medicine assets of Biodex enables Mirion Medical to focus on our strategic priorities and better aligns the group with Mirion’s mission of harnessing our unrivaled knowledge of ionizing radiation for the greater good of humanity. We are pleased to see the physical medicine business in the hands of an owner whose core mission and strategy is better aligned with investing in the future of the product line and finding valued employees the right home for their skills and contributions,”
Mike Rossi, President of Mirion Medical
Mirion Technologies is a leading provider of detection, measurement, analysis and monitoring solutions to the nuclear, defense, medical and research end markets. The organization aims to harness its unrivaled knowledge of ionizing radiation for the greater good of humanity. Many of the company's end markets are characterized by the need to meet rigorous regulatory standards, design qualifications and operating requirements. Headquartered in Atlanta (GA – USA), Mirion employs around 2,800 people and operates in 13 countries.
About Biodex Medical Systems
Biodex Medical Systems, Inc. is part of Mirion Medical, Inc., a group of healthcare-focused brands within Mirion Technologies. Mirion Technologies, Inc. uses science and technology to drive treatment innovation across physical medicine, nuclear medicine and medical imaging categories. With a history of manufacturing and engineering excellence that spans more than 60 years, the Biodex™ mission is to provide innovative solutions and customer-driven support to medical facilities and wellness centers around the globe.
BUSINESS INSIGHTS, PHARMACY MARKET
Tetris Pharma Ltd | December 13, 2022
Tetris Pharma Ltd a subsidiary of biopharmaceutical company, Arecor Therapeutics plc announces that it has signed a service agreement with Syneos Health® the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success, to support the build out of Tetris Pharma’s commercial platform across Europe.
Through this partnership, Syneos Health will provide commercial support through an outsourced contract sales services to accelerate healthcare practitioner awareness of Tetris Pharma’s flagship product, Ogluo®, for people living with diabetes across initial launch territories.
“Following the recent launch of Ogluo® in Germany, we are focused on continuing its accelerated roll-out across Europe. Syneos Health was one of several potential partners that were evaluated during the process of partnering with an organisation that would provide a multitude of commercial options to help establish the product across Europe. Partnering with Syneos Health, a leader in clinical research, medical affairs, and commercialisation services for the pharmaceutical industry, is key to building our reputation as specialists in the marketing, sales, and distribution of commercial-stage specialty hospital products across the UK and Europe.”
Dr. Shafiq Choudhary, Managing Director, Tetris Pharma
iA | November 18, 2022
iA, a provider of software-enabled pharmacy fulfillment and automation solutions, celebrated three of its employees being recognized at Drug Store News’ Fourth Annual Top Women in Health, Wellness & Beauty Awards held in Chicago, Illinois.
Rachael Clark, Vice President of Commercial Sales, received a Rising Star award. As Vice President of Commercial Sales, Rachael works with large-scale retail chain grocery stores, mainstream pharmacies, and digital pharmacies, as well as independent mom-and-pop operations. Rachael is responsible for a team of account executives that work to promote iA’s technology across North America and globally by developing long-term strategies, while also organizing and maintaining sales operations.
Bobbi Jamriska, Senior Vice President, Product Management, received an award for Business Excellence. Bobbi leads the Product Management team at iA that is responsible for the iA portfolio of solutions, where she manages the strategy, development, and go-to-market planning. She has been a pharmacy tech for 12 years, and has led global product management initiatives as well as new product development experiences.
Stacey Weber, Senior Director of Customer Operations, received an award for Business Excellence. Stacey oversees the customer support division, where she manages a team of 35 remote technicians who assist customers in using iA’s Rx fulfillment solutions, which include automated prescription filling robots and innovative warehouse management systems. In addition to ensuring customers receive timely and helpful assistance, she also oversees standardization and process improvement for iA’s call center and for the customers that use iA solutions.
“We are incredibly proud of our team members. Rachael, Bobbi, and Stacey all represent the best of iA, and we are very lucky to be able to work with them every day.”
Tom Utech, President and Chief Operating Officer
iA is a leading-edge provider of software-enabled pharmacy fulfillment solutions. With over 30 years in pharmacy fulfillment, iA has invented and developed a suite of software-driven pharmacy automation solutions. From NEXiA software to automated modular hardware and sophisticated counting and collation devices, iA pharmacy automation solutions and technology empower pharmacists. iA can run the prescription fulfillment process from end to end, helping pharmacies manage fulfillment and inventory to help lower costs, improve efficiency and provide comprehensive Rx tracking and real-time support.