The dynamics of healthcare are changing with the invention of advanced innovative systems, enhancing the quality of life. Gene therapy is the result of one such innovation that holds the potential to revolutionize the treatment of various diseases including Osteoarthritis – a highly debilitating disease of the joints. Osteoarthritis (OA) is caused by a combination of genetic and environmental factors, where the cartilage breakdown leads to pain and reduced joint function. It is estimated that nearly 500 million patients suffer from OA globally.
To overcome this challenge, Remedium Bio designed a solution using gene therapy and believes that their investigational treatment is capable of turning back the clock on Osteoarthritis, potentially delaying joint replacements. Their novel approach to gene therapy drug development and innovative platform technology may be disruptive for OA and a number of other serious unmet clinical needs.
We at Insights Care found this fascinating and are eager to know the workings of this technology. Recently we had the opportunity to interview Frank Luppino – President and CEO at Remedium to learn more about their novel approach.
Below are the highlights of the interview:
Kindly tell us about your journey and inspiration behind venturing into the field of Rheumatology.
Remedium’s team has been at the forefront of developing innovative rheumatological and musculoskeletal disease treatments for over 2 decades. In that time, we have developed a number of innovative and market-leading products that are still on the market today. These include the US-leading palliative therapies for Osteoarthritis – Monovisc and Orthovisc, currently distributed by Johnson and Johnson, the first dual-mechanism corticosteroid-hyaluronan product – Cingal, and the first focal cartilage lesion cell therapy treatments.
While we are proud of these market-leading, innovative therapeutics, we remained unsatisfied because disease-modifying treatments for Osteoarthritis (OA) have thus far been elusive. All the treatments available to patients at this time are strictly palliative, treating only the symptom of the disease, and are generally incapable of reversing cartilage loss, which is highly predictive of future joint replacement surgery. No currently approved disease-modifying therapeutic for the treatment of OA is currently available anywhere around the world and it is estimated that nearly 500 million patients suffer from OA globally.
We started Remedium to bring the significant benefits of gene therapy to large unmet needs in healthcare and with our lead product targeting the largest unmet clinical need in rheumatology – Osteoarthritis. The goal was to unleash the power of the only therapeutic with the potential to reverse cartilage loss, FGF18, by overcoming the pharmacokinetic challenges inherent with intra-articular injections. We designed a solution that utilizes the most well-studied gene therapy delivery vector, which has shown unprecedented regenerative performance in osteoarthritis disease models, and one that we believe may for the first time effectively and efficiently delay joint replacement surgery. Remedium is now working to advance this therapeutic combination to first-in-human trials.
What is the company about? How is it contributing to the improved health and well-being of the patients?
Remedium’s broader focus is the development of treatments for large unmet clinical needs. In line with this, Remedium is also developing a novel adjustable-dose gene therapy, a technological innovation that can allow for the delivery of a number of subcutaneously administered protein-based treatments as low-cost, safe, and effective adjustable-dose gene therapies. We call this platform – Prometheus and our goal is to bring “Adjustable Gene Therapy” to the field of medicine. To enable the advancement of our lead asset and platform technology, Remedium partners with Boston-area academic institutions to test its innovations. Through partnerships with academia, we can bring our technologies to the market faster and more efficiently, relying on expert-developed preclinical models to thoroughly evaluate our products.
Can you elaborate upon the core values on which the company is built and what is its mission? How are these aligned with patient health?
Remedium was founded by execution-oriented industry veterans, and operates with an efficient, focused development model. We leverage our Boston location to partner with leading research universities to demonstrate preclinical feasibility and proof-of-concept more efficiently than with using traditional commercial alternatives. Technology is at the core of our value proposition, and we aim to further streamline product development by modularly applying elements of proven technologies to treat well-characterized pathology. We believe this approach decreases translational risk and speeds development in a way that can get breakthrough therapies to patients sooner.
In line with this strategy, our lead candidate treatment for OA combines the only disease modifying therapeutic, which has shown efficacy in placebo-controlled trials, with the most highly characterized gene delivery vector. Using a therapeutic that has demonstrated the ability to increase cartilage thickness, delay joint replacement, and impact progression of pain in placebo controlled trials, greatly derisks our development pathway and reduces clinical trial design complexity. Similarly, using gene therapy vectors and genetic sequences which have been extensively evaluated for intra-articular delivery and in human clinical studies, reduces the technical project risk enabling more rapid advancement of the therapeutic to the clinic.
What advice would you like to give to budding entrepreneurs and enthusiasts who desire to engage in the Rheumatology sector and ease the lives of patients?
Both the rheumatology sector and the general field of musculoskeletal diseases have been leading the charge of innovation. Starting with regenerative bone morphogenic proteins and more recently with the advancement of the chondro-regenerative FGF18 into late-stage clinical studies. However, the field is still ripe for innovation ranging from specific treatments targeting the underlying pathology of rheumatoid arthritis to the regeneration of cartilage, subchondral bone, and the greater joint capsule in osteoarthritis. Our advice to entrepreneurs is to relentlessly push forward the boundaries of regenerative medicine, targeted, disease modifying, and patient-focused – there is no shortage of diseases to cure!
How do you envision scaling the company’s services and operations in 2023 and beyond?
2023 will be an important year in the company’s growth cycle as we are planning to complete our Series A round financing. This financing will not only enable the advancement of our lead candidate gene therapy for Osteoarthritis through IND approval and allow for the initiation of first-in-human studies, but will provide Remedium with the resources to bring our novel approach to a broad range of clinical indications ripe for disruptive innovation.