"Our ultimate goal is to shift the paradigm of treating Lyme disease from uncertainty, misunderstanding, and helplessness, to one of clarity."—Scott Santarella

In an effort to move beyond anecdotal evidence to sound scientific validation in the Lyme treatment equation, Global Lyme Alliance (GLA) announced today that it is expanding its research efforts to include the first in a series of clinical studies to determine the effectiveness of non-validated, physician-developed Lyme treatment regimens.

At the request of a small group of motivated patients, GLA is taking the bold step towards validating community-based, physician-developed, Lyme disease treatment regimens by using the rigorous evidence-based clinical research process. “There’s a high level of ambiguity surrounding the multitude of treatment options being offered to patients throughout the Lyme community; as such, GLA is committed to evaluating, through established scientific assessment, the efficacy of these patient care approaches,” said Timothy Sellati, Ph.D., GLA’s Chief Scientific Officer (CSO).

GLA’s first study will focus on the treatment regimen developed by Joseph Jemsek, M.D., the founder of the Jemsek Specialty Clinic of Washington D.C. Dr. Jemsek was chosen for his willingness to put his “Jemsek Protocol®” to the test following a thorough evaluation by GLA of several patients who experienced positive results from working with the physician.

“I am honored to be selected by GLA to be a part of their first study,” said Dr. Joseph Jemsek. “ I am confident in the treatment regimen I have developed to help patients suffering from this insidious disease and look forward to putting it through the extensive scientific assessment detailed in the clinical study.”

Through this initiative, a range of microbiological, immunological, genetic and metabolic assays will be conducted to distinguish patients who experience varying degrees of clinical improvement vs. those who do not along with a series of quality of life assessments. Within the patient population that responds favorably, changes in specific biomarkers may offer insights on why the Jemsek Protocol works. “By collaborating with multiple prestigious academic partners, our hope is that at the end of this study we’ll identify biological-based indicators of treatment success that can be broadly used in evaluating other treatment options being pursued by Lyme patients suffering from persistent symptoms,” said Dr. Sellati.

To support this and GLA’s growing pipeline of studies GLA’s CSO has assembled a team of experts in clinical project development and management, regulatory compliance, biostatistics and Lyme disease nursing. These individuals as well as the GLA’s bio- and data-repositories will ensure the integrity of the clinical study process, the collected data and biospecimens.

“Our ultimate goal is to shift the paradigm of treating Lyme disease from uncertainty, misunderstanding, and helplessness, to one of clarity. Our Lyme community has expressed frustration with the slow progress in Lyme research, lack of treatment options and specifically, the lack of scientific buy-in on community-based treatment regimens. We listened to their concerns and are committed to supporting research that impacts the Lyme community today,” said Scott Santarella, GLA’s CEO. “We have to put all the science we can behind this disease, including the disparate treatments being offered to patients. The Lyme community deserves more.”

Lyme disease is the most common vector-borne illness in the U.S., and its incidence is growing rapidly. More than 427,000 people in the U.S. are newly diagnosed each year. Moreover, up to 20% of those who are diagnosed and treated early with standard-of-care antibiotics continue to suffer from a variety of symptoms. A recent GLA study estimated that more than two million patients could suffer from post-treatment Lyme disease by 2020. GLA is committed to better understanding treatment options to help patients.

For questions about GLA call 203-969-1333 or visit GLA.org. For questions regarding the clinical study contact 833-GLA-LYME (833-452-5963).

About Global Lyme Alliance

Global Lyme Alliance is the leading 501(c)(3) organization dedicated to conquering Lyme and other tick-borne diseases through research, education, awareness, and patient services. GLA has gained national prominence for funding some of the most urgent and promising research in the field, while expanding education and awareness programs for the general public and physicians. We support those around the globe in need of information about tick-borne diseases, finding a Lyme treating physician, and with the first Lyme-specific peer-to-peer mentor support program. Learn more at GLA.org.