Timing is everything in drug development and medicine.
French biotech Valneva is hoping now is the time for a Lyme disease vaccine as it embarks upon its first clinical trials.
On December 9, the company announced it had received a green light from the U.S. FDA to pursue its investigational new drug (IND) application, as well as approval of a Clinical Trial Application (CTA) in Europe. Valneva will now begin a Phase 1 safety and tolerability study with 180 patients in the U.S. and Belgium.
It sounds promising, but there’s a catch. We have been here before.
SmithKline Beecham, now part of GlaxoSmithKline, ushered a Lyme disease vaccine to the market in 1998. Known as LYMErix, the product was pulled in 2002. According to the company, the withdrawal was due to poor sales.
Strangely enough, there was — and still is — a great need for a vaccine.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
An estimated 30,000 Lyme disease cases are reported to the CDC every year, but the department estimates the true number of infections to be closer 300,000. The disease has become more prevalent in recent years, clustering in the northeast of the country. A further 85,000 cases occur annually in Europe.
The disease is caused by the bacterium Borrelia burgdorferi, which is passed to humans through the bite of infected blacklegged ticks. Standard symptoms include fatigue, dizziness, swelling, joint and nerve pain, and a characteristic “bullseye” skin rash called erythema migrans.
Debates have raged for years about whether some patients develop a chronic form of the disease, with fatigue and joint pain that persists for more than six months after treatment with antibiotics. The existence of this post-treatment Lyme disease syndrome (PTLDS) is an important part of the picture when calculating the impact of the disease.
As far as prevention, the CDC provides recommendations for limiting exposure to ticks, but there’s only so much that can be done against an ever-present threat.
Valneva’s vaccine could offer a second layer of protection. In preclinical trials using mice, it conferred resistance to the majority of Borrelia species that are hazardous to humans. Is that enough?
Despite showing efficacy in large clinical trials, sales of LYMErix in 2002 were dismal and declining when the company pulled the plug. It had entered a market situation that was more complex than supply and demand.
After the FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) was in charge of setting the guidelines for who should be vaccinated. Their decision was very conservative, acknowledging the minor harm patients encounter with a short term bout of the disease.
The vaccine wasn’t directly ‘recommended’ for anyone, even those in high-risk areas. At its most prescriptive, the ACIP said the vaccine “should be considered.”
As an elective vaccine, the manufacturer didn’t have protection against consumer lawsuits. And many claimed they had side effects. One Philadelphia law firm filed a class action suit with over 100 names.
Word got out about the side effects and sales declined further.
In 2002, researchers at Children’s Hospital Boston and Harvard School of Public Health published a paper detailing the misinformation and confusion that surrounded the first vaccine: The Lyme vaccine: a cautionary tale. It’s something the Valneva team should probably read.
Photo: jwilkinson, Getty Images
