Overall, results from the phase III Valor trial testing Lyme disease vaccine PF-07307405 “strengthen confidence” in the candidate, according to partners Pfizer Inc. and Valneva SE, with the big pharma now looking toward regulatory submissions. Investors, however, focused on the fact that the study, which demonstrated more than 70% efficacy in preventing Lyme disease in individuals, ages 5 and older, failed to hit the statistical criterion for the first prespecified analysis.
En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
Lyme disease is a multisystemic zoonotic infection caused by Borrelia burgdorferi bacteria transmitted by ticks. Lyme disease is a public health problem because of its high incidence in North America and Europe and its increasing presence due to the impacts of climate change on vector distribution. Novel, effective vaccines to prevent the disease are, therefore, urgently needed.
The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.
Researchers from Purdue University and the National Institutes of Health (NIH) have identified a potential target for treating Lyme disease, a prevalent tick-borne illness of increasing concern worldwide. Current treatment for Lyme disease is based on long-term administration of broad-spectrum antibiotics, with significant costs and impact on patients’ quality of life.
Lyme disease, caused by the bacterium Borrelia burgdorferi, is the leading tick-borne infection. Between 10% and 35% of patients show post-antibiotic treatment Lyme disease syndrome, with symptoms including fatigue, cognitive issues, memory loss, neuropathy, joint pain, musculoskeletal pain, sleep issues, depression and others.
With its sights set on expanding the commercial launch of Xdemvy (lotilaner ophthalmic solution, 0.25%) to treat Demodex blepharitis in the U.S., Tarsus Pharmaceuticals Inc. has priced an underwritten public offering of common stock, selling 2.8 million shares for $32 each, taking the expected gross proceeds to about $100 million.
Immuno Technologies Inc. and affiliated organizations have published preclinical data on a novel parainfluenza virus 5 (PIV5)-vectored intranasal vaccine for Lyme disease.
Traditionally developed antibiotics generally act inhibiting essential bacterial enzymes. However, new strategies are urgently needed to discover novel antibiotics against bacterial infections, such as Lyme disease caused by Borrelia burgdorferi. The chaperone high-temperature protein G (HtpG) is a nonessential bacterial protein containing a desirable druggable domain.
Borrelia burgdorferi, one of the bacteria species causing Lyme disease, has a small genome and is therefore highly dependent on its hosts to obtain many necessary metabolites. Its small genome makes B. burgdorferi an attractive candidate for developing narrow-spectrum antibiotics targeting those essential genes. The use of narrow-spectrum antibiotics may reduce the risk of side effects and the spread of antimicrobial resistances compared with traditional, long-term antibiotic treatments.
