Lyme disease plagues the country but one 100+ year nonprofit research unit, UMass Medical School’s MassBiologics, seeks to change that. By intensely focusing on the demise of Lyme disease with a seasonal preventative treatment, the organization now readies for a clinical trial hopefully this year to evaluate the new Lyme pre-exposure prophylaxis (Lyme PrEP).
Lyme Disease: A Real Problem
A bacterial illness that can cause fever, fatigue, joint pain and skin rash—not to mention more serious joint and nervous system complications—Lyme disease is the most common vector-borne disease (transmitted via mosquitoes, ticks or fleas) in the United States. In recent years up to 30,000 cases are reported per year according to the Centers for Disease Control and Prevention (CDC). But agencies such as the Environmental Protection Agency (EPA) think the number could be far greater.
Enter Lyme PrEP
Led by Dr. Mark Klempner, executive vice chancellor for MassBiologics—governed by UMass Medical School—a research team at this 100+ year old nonprofit dedicated to public health, is committed to developing and delivering to market a treatment for Lyme disease. Known as Lyme pre-exposure prophylaxis (Lyme PrEP) this novel therapy may hopefully take out Lyme disease for good. The experimental treatment is nearly ready for Phase I clinical trials—with a goal of initiating a Phase I clinical trial in 2020.
A success clinical program could lead to actual market availability by 2022 as reported by Brittany Flaherty of STAT in 2019. An actual clinical trial dates is close reports Jessica Bartlett with the Boston Business Journal. Bartlett reports that the researchers are fundraising for the work to move closer to market.
Clinical Research Costs
Last year they secured $1 million based on an appropriation from the Massachusetts state budget.
Lyme PrEP is a specific human monoclonal antibody that defends against Lyme disease. However, it isn’t quite a vaccine in that it exploits a protein that specifically targets and blocks the Lyme-causing bacteria in the tick after it bites an inoculated host. In this way it delivers a single defense antibody, reported Dr. Mark Klempner to STAT. In 2019, UMMS sought $800,000 in the fiscal 2020 state budget to add to $2.1 million in funding to enable lead investigator, Mark Klempner and team to set up a clinical trial to gest the safety and stability of the treatment, author an Investigational New Drug (IND) application for FDA approval to conduct clinical trials in humans.
Who is MassBiologics?
Boston-based MassBiologics ,a nonprofit vaccine manufacturer overseen by the medical school, is the actual developer of Lyme PrEP. Representing the only nonprofit FDA-licensed manufacturer of vaccines in the United States, they have been active for over 100 years working to improve public health through applied research, development and production of biologic products, including vaccines, plasma derivatives and most recently, monoclonal antibodies. They currently make Teanus and Diphtheria Toxoids, Adsorbed (Td) vaccine and distribute nationwide. MassBiologics is overseen by the University of Massachusetts Medical School (UMMS) and the two collaborate ongoing in research for the development of products that benefit patients.
Mark Klempner, MD, Executive Vice Chancellor
Call to Action: For those interested in finding a way to stop Lyme disease, this imminent clinical trial represents an important milestone in that process. Learn how to support the nonprofit MassBiologics.Source: Boston Business Journal