A promising antibody in the fight against Lyme disease

BOSTON A researcher at UMbad Medical School said Thursday that an additional $ 1 million investment in the search for a solution to prevent the spread of Lyme disease by ticks revealed an investment additional could move a laboratory-proven antibody for the protection of mice against Lyme disease. .

Like Lyme disease, a bacterial infection transmitted by ticks that can cause neurological problems if left untreated, has spread both in the number of cases and in the affected geography, the Dr. Mark Klempner of MbadBiologics Division of UMbad Medical School leads a development team "A New Approach" to Prevent Illness.

"This has really been a rising tide and worrying cases," he said, pointing out that the 35,000 to 40,000 reported annual cases of Lyme disease in the United States are "very under-reported" and should to get closer to 300,000 annual cases. Since the mid-1990s, he said, ticks likely to transmit Lyme disease have increased in concentration and spread from New England and the center of the Atlantic coast to the Highlands. Midwest.

The Klempner team received a $ 1 million credit from the current state budget and, together with the federal grants from the National Institutes of Health, developed a "pre-exposure prophylaxis" in which antibodies injected to a human could block the release of Lyme bacteria if the man is bitten by an infected tick.

"It's really based on a very simple idea that the bacteria, before coming to you, is stuck in the tick's gut" and has to make a complex journey through the tick before it's over. it can infect a human, he said Thursday at a briefing. "Our approach is to take advantage of this very complex path to allow bacteria to get out of the tick and get into you … a medicine that will circulate in you and that when the tick drinks it, the blood will contain something that will kill the bacteria in the midgut or to keep it out of the gut so that none of this can happen. "

The team performed an initial test on mice in which the antibodies were injected into the mice and then exposed to six ticks infected with Lyme disease. At doses as low as 5 mg per 2.5 kilos of body weight, the mice were found to be 100% protected against Lyme disease, Klempner said. The team also tested the preventive treatment on a monkey and was able to protect it from exposure to Lyme disease.

The development hit an obstacle, Klempner said, when his team realized that a simple injection of antibodies would not protect a human during the tick season.

"Our problem is that we have invented a drug that will only be there for a few weeks and yet your risk of exposure is several months, we usually say seven to eight months in our region," he said. he declares.

Researchers have found a way to modify antibody treatment and extend its usefulness up to three and a half times in mice, he added, but have not yet been able to test on humans to determine the lifetime of the antibodies. a human body.

That's where a new state investment would come in, according to John Erwin, vice-chancellor of government relations at UMbad Medical School. The school is asking for $ 800,000 in the fiscal year 2020 budget, he said, which, along with more than $ 2.1 million from the school, would help the school. Klempner team to test the safety and stability of its treatment, to prepare and file a new drug application with the Food and Drug Administration and to start conducting the first human trial.

Klempner said he hoped to obtain FDA approval to conduct modified studies for the second and third phases of the development of the treatment, which would be cheaper and would eventually bring the treatment to market faster. The second phase of the study, he said, would typically cost up to $ 50 million, but could be done for an amount close to $ 5 million if the FDA approves the test plan amended.

"If it is not the case, I will have to collaborate with major pharmaceutical companies – it's as simple as that," Klempner said. According to the most optimistic scenario, treatment could be available in about three and a half years.

If or when treatment becomes commercially available, the state could expect to recover its investment. Under the terms of the funding, Klempner and Erwin stated that MbadBiologics was required to make treatment available to Mbadachusetts residents at a lower cost and to reimburse public funds.

Although other states fund Lyme disease education efforts, Klempner said Mbadachusetts was the only one actively trying to find a solution.

"I do not know of any other state that funds the development of drugs," he said. "I think it's totally unique."

HNSS