Improving the Lives of Bladder Disease Patients

September 27, 2019
Elaine Quilici
Pharmaceutical Executive

Dr. Chris Cutie, chief medical officer of TARIS Bio, discusses his focus on creating new therapies for the often-misunderstood bladder disease population.

Diseases of the bladder, including muscle-invasive bladder cancer and overactive bladder (OAB) can significantly compromise a patient’s quality of life. Current urology drugs seem to fall short when it comes to treating these conditions. Oral therapies for OAB have even been linked to increased risk of dementia.

TARIS Bio uses a local approach to treat the bladder and optimize efficacy without systemic toxicity. Here, Dr. Chris Cutie, chief medical officer of TARIS Bio, speaks to Pharm Exec about his journey from treating urology patients firsthand to working for a company that is focused on creating new therapies to improve the lives of an often-misunderstood population.

Pharm Exec: How did you go from being a urologic surgeon to a leader in the industry?

Chris Cutie: Being entrusted with the care of another in the operating room is both incredibly humbling and inspiring. Practicing as a urologist for several years afforded me the opportunity to intimately understand the issues patients suffering from urologic conditions face on a daily basis, from diagnosis through treatment to recovery. What makes urology such a unique specialty is the ability to remain present in the patient journey long after the initial surgery or treatment. While taking care of patients at the personal, individual level was tremendously rewarding, I knew that I would one day seek to treat patients at a population level and try to affect change across a variety of conditions.

After initially working with TARIS for over three years as a clinical advisor, I knew that this team was uniquely positioned to leverage cutting-edge science and efficient delivery systems to enable clinically meaningful benefits in patients with both benign and malignant genitourinary diseases.

It gives me great personal and professional satisfaction to work at TARIS Bio, a small, scrappy company singularly focused on the development of transformative treatment options for patients and their families. While I do miss the operating room and the life of a surgeon, I know that we will one day have a positive impact on many more patients than I could ever have hoped to personally come to know and treat.

PE: How are bladder cancer and OAB patients misunderstood, and how can that be rectified? What is your experience with these patients, and how are you partnering with them to advance treatment options?

CC: Bladder cancer is the fifth most common cancer in industrialized countries and affects roughly 2.7 million people globally. A large percentage of these patients are unfit for traditional treatment methods, such as bladder removal or chemotherapy, due to their underlying frailty and health issues. Unfortunately, many of these patients go on to only receive palliative care. They often never learn about clinical trials that may be available to them. Our ongoing clinical trials in bladder cancer provide hope for these individuals, who may wish to access these novel potential therapies and, in their own way, help advance the science of the field for other patients, both now and in the future.

Overactive bladder and incontinence have profound effects on patients, negatively impacting their quality of life and often resulting in behavioral modifications that may limit one’s ability to pursue activities that they may have previously found to be enjoyable and meaningful. Fearing a wet event or soiling of clothes, these folks avoid bicycle rides, walks in the park, sporting events, and family outings. They map toilet locations around them and avoid travel to new or unfamiliar places. Misconceptions around bladder dysfunction can often lead patients to feel embarrassed or stigmatized.

In one important study, the quality of life impairment among OAB patients was found to be third only to Alzheimer’s disease and stroke. For such a potentially treatable condition, these data are sobering.

We at TARIS aren’t working in this space every day just to affect an incremental improvement-we hope to provide them an opportunity to get their lives back, going back to the activities and lifestyles that they once found so fulfilling. At the end of the day, we’re working with these populations to design solutions that can extend and improve their quality of life.

PE: What are some issues with current bladder cancer and OAB treatment, and why is there need for improvement?

CC: Current treatments for both bladder cancer and OAB are often limited by significant systemic or local side effects.

For bladder cancer, curative intent therapies, including radical surgery, systemic chemotherapy, and radiotherapy, are often associated with morbidity, permanent life-altering treatment effects, and even death. As bladder cancer is typically diagnosed later in life, older, frail patients are especially vulnerable and susceptible to these treatment risks.

Today’s mainstay oral therapies for OAB are hampered by adverse events such as dry mouth, dry eye, constipation, blurred vision, and dizziness. Unfortunately, any modest improvement in efficacy is tied to an increase in side effects. This results in poor treatment compliance and low satisfaction with therapy, especially in patients with more substantial symptom burden. A majority of patients quit oral therapies within one year due to treatment dissatisfaction.

These agents also have been tied to an increased risk of permanent cognitive decline and dementia, which is especially concerning for a condition that becomes more prevalent with advancing age. One agent of a new class appears to have more manageable side effects, but unfortunately its efficacy is not terribly compelling.

More involved therapies include surgical implant of a neurostimulation device into the lower back, or multiple injections of botulinum toxin into the bladder wall via an endoscopic procedure. These approaches demonstrate improved efficacy, but are clearly more invasive and incur limiting adverse events as well. A substantial need exists for therapies with better efficacy, reduced adverse events, and improved patient convenience and compliance.

PE: How is TARIS’ approach to bladder cancer and OAB innovative?

CC: Historically, the bladder has been considered merely a storage organ with a basic fill/empty function. The bladder is in fact an intelligent organ with a surprisingly rich immune environment. We at TARIS have made terrific progress unlocking previously unrecognized epithelial biology within the bladder. We have also sought to optimize access to bladder disease targets with little to no systemic drug exposure. There may even be an opportunity in the future to utilize the bladder as an access point to the body’s broader immune system. Much work remains, but early glimpses at this potential are compelling.

At TARIS, we also excel in the ability to unlock novel and previously unknown drug properties that work with the bladder’s unique design and function. Our approach to local and continuous bladder treatment is simple to administer, well-tolerated, and ensures compliance to therapy. These treatments have the potential to revolutionize the management of benign and malignant genitourinary diseases.

PE: When do you expect these drugs will be available to patients, and how do you intend to market them?

CC: Both TAR-200 for the treatment of muscle-invasive bladder cancer and TAR-302 for OAB are heading into later stage development. We look forward to further exploring these drugs through robust clinical trials. If these products are ultimately approved by FDA, TARIS would look to build a specialty commercial organization to market to the concentrated prescriber base of urologists. The field is rapidly moving to large group practice structures, where co-located urologists cover multiple sub-specialties, including cancer and OAB. This model enables smaller, nimble companies like TARIS to work with physicians in a more direct and collaborative manner.

PE: Do you foresee any market access issues in getting these drugs to patients at an affordable price?

CC: It’s not a secret that the American healthcare system is very expensive. Everyone has a role to play in managing those costs. TARIS takes this commitment very seriously. Our best approach to address this issue is by focusing on the value we can deliver to patients: We target patients with serious and life-limiting diseases and develop therapies that aim to make drastic improvements in those patients’ lives. These improvements generally reduce overall costs of disease, by avoiding things like early mortality, repeat hospitalizations, lost work and caregiver time, and reduced quality of life.

If we’re doing our job well and advancing therapies that address these needs, we expect to be able to deliver benefit to patients at a price that patients, insurers, and the company can all feel good about.

 

Elaine Quilici is Pharmaceutical Executive's Senior Editor. She can be reached at equilici@mmhgroup.com