Increase in GI-disease diagnoses nudges researchers to take action

At Johns Hopkins University, you can find innovative scientists who are researching solutions to common problems like an increasing population of individuals with chronic digestive diseases.

With five large research universities, it is no surprise that Maryland is a hub for brilliant minds. One of these research universities is Johns Hopkins University (JHU). At JHU, you can find innovative scientists, not only students but faculty, who are researching solutions to common problems like an increasing population of individuals with chronic digestive diseases.

Nearly 70 million Americans are affected by gastrointestinal (GI) diseases each year. Of those GI diseases, inflammatory bowel disease (IBD) is common. According to the Centers for Disease Control and Prevention (CDC), “an estimated 3.1 million adults (1.3%) in the United States have been diagnosed with inflammatory bowel disease, which includes Crohn’s disease and ulcerative colitis.”

Concerned about this increasing population, Diane Peters, DVM, Ph.D., M.S., assistant professor of pharmacology and molecular sciences at JHU and a member of the Johns Hopkins Drug Discovery Pharmacology Division at Johns Hopkins Medicine, took action.

With support from TEDCO’s Maryland Innovation Initiative (MII) and in partnership with the Crohn’s and Colitis Foundation, Peters is researching new treatment options for these individuals, including an orally administered drug she hopes will change the tide.

According to Peters, 40% of IBD patients are nonresponsive to drugs and existing treatments; this is why Peters is researching the viability of an orally administered gut-restrictive drug, (S)-IBD3540. The new drug inhibits the enzyme glutamate carboxypeptidase II (GCPII), which is dramatically up regulated in the GI system of IBD patients. By inhibiting this enzyme, researchers have seen an effective anti-inflammatory response in rodent models of IBD, eliminating constipation and resulting in normal GI function.

The MII program’s intent is to foster commercialization of innovative technologies through technology validation, market assessment and the creation of startup companies in Maryland from qualified universities.

Peters said, “With MII funding, we performed essential safety studies in rodents, demonstrating that at very high doses there are no adverse effects on GI structure and function in mice. This promising safety profile is encouraging as (S)-IBD3540’s moves toward clinical development.”

While this is the first time Peters has worked with the MII program, she is part of “The Slusher Lab,” a team of 25 medicinal chemists, assay developers, pharmacologists, toxicologists and pharmacokinetics/drug metabolism experts led by Barbara Slusher, Ph.D., M.A.S., director of the Johns Hopkins Drug Discovery Program and a professor of neurology. The team strives to identify novel drug targets that can be translated into new drug therapies for clinical development.

“We have been extremely successful in partnering with the program, moving research to clinical studies and determining which commercialization path is best,” said Slusher, who has supported multiple researchers from her team through the MII program.

Her experience moving ideas from lab to clinic and developing products for commercialization has been extremely helpful to researchers like Peters.

“Dr. Slusher recommended the MII program and, due to her past experience, she was able to provide insightful feedback. The TEDCO team offered a level of support higher than anticipated. There was continuous interaction throughout the duration of the project, which is different from other funding mechanisms. They provide more than funding – their expertise in commercialization was very helpful. They make you think differently,” said Peters.

“Young investigator” researching improvements to patient care

Meanwhile, another researcher at JHU is partnering with MII to bring the innovative research to use in the commercial market. Venkata Akshintala, M.B.B.S., a specialist in endoscopic medicine and an assistant professor of medicine at Johns Hopkins School of Medicine, seeks to use technology to address patients’ unmet needs, allowing for improved overall patient care. Currently, this research is leading him to improve patient care during and after colonoscopies.

Colonoscopies diagnose or evaluate GI disorders such as colon polyps, colon cancer, diverticulosis and IBD. According to the American College of Gastroenterology, colonoscopies allow imaging of abnormal findings as well as therapy or removal of lesions or precancerous polyps. However, when large polyps are removed patients may experience bleeding at the removal site.

Akshintala has participated in TEDCO’s MII program several times, including to determine the commercial viability of a gel he developed that would reduce the bleeding affecting many patients who undergo an endoscopy for polyps removal. The mucoadhesive gel contains epinephrine nanoparticles lasting as long as 72 hours, stopping the bleeding and allowing the wound to heal.

“MII not only helps with funding opportunities but provides guidance for success to ensure a product is commercially viable. It helps researchers reach patients in the real world. Research and innovation are very different. The ability to take research further to commercialization is what sets MII apart from other grants,” said Akshintala.

Arti Santhanam, Ph.D., executive director of MII, said, “The support and insight we offer in addition to our funding is especially crucial to first-time faculty entrepreneurs who may need more structure and guidance to think differently about the impact of their research. After researchers go through the MII program, they become more commercially minded and often want to come back to apply again for other projects.”

Akshintala refers to himself as a “young investigator” who researches all the time. He’s excited to work with TEDCO and the MII program again, this time to help patients suffering from pancreatitis.

According to Akshintala, 60,000 people suffer from pancreatitis each year and 15% of acute pancreatitis patients develop necrosis of the pancreas, resulting in necrotic debris surrounded by a wall of granulation tissue called “walled-off pancreas necrosis” (WOPN).

Patients with WOPN often develop infections within the necrotic debris that can make them sick. Due to the small, delicate space, several endoscopy sessions are required to remove the debris, which requires multiple trips and risks of additional complications. Akshintala has developed a safe chemical dissolution product to facilitate the breaking down and dissolution of the debris in one procedure.

“The technology validation and market assessments completed through the MII program help build confidence in emerging technologies and increase interest from investors. This is important to addressing the so-called ‘valley of death’ gap in funding between academic research grants, such as NIH and SBIR, and grants that support commercialization,” said Snell.

Santhanam added, “When we – the state of Maryland – show confidence in a company and a commitment to help it grow, we are able to help drive additional investments. Our purpose is to grow companies in Maryland and to be a trusted entity and good partner for other investors.”

TEDCO, the Maryland Technology Development Corporation, enhances economic empowerment growth through the fostering of an inclusive entrepreneurial innovation ecosystem. TEDCO identifies, invests in, and helps grow technology and life science-based companies in Maryland. Learn more at www.tedcomd.com.