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Flightpath Biosciences Begins Human Clinical Testing of the World’s First Narrow-Spectrum Antibiotic Targeting Lyme Disease

DETROIT, Michigan, May 10th, 2024 — Flightpath Biosciences Inc., a clinical-stage life sciences company developing therapeutics to treat infectious diseases, announced today that the first healthy volunteer participants have been dosed in its Phase I clinical trial of FP-100 (hygromycin A), an orally-available, narrow-spectrum antimicrobial drug candidate. The single center, prospective, randomized, double-blind, placebo-controlled study of single-ascending doses and multiple-ascending doses of FP-100 administered orally will include a maximum of 72 healthy adult volunteers to evaluate the safety, tolerability and pharmacokinetic profile of the drug.

This announcement coincides with Lyme Awareness Month and is meant to provide the community-at-large with a long-awaited reason for optimism related to new treatment strategies. Lyme disease is the fastest-growing vector-borne illness in the U.S., with an estimated 476,000 new cases every year. Today, generic, broad-spectrum antibiotics are the standard-of-care for treating early Lyme disease. However, current treatments fail to achieve symptom resolution up to 20% of the time which can lead to long-term complications. Further, it is widely known that overuse of broad-spectrum antibiotics, can damage the human microbiome, cause gut dysbiosis and lead to immune dysregulation and, in some cases, cause chronic disease (Blaser et al). The repeated, large-scale use of broad-spectrum antibiotics leads to resistance in non-target bacteria, contributing to the Antimicrobial Resistance Crisis (AMR).

“While Flightpath’s primary goal in conducting this phase I trial of our lead drug candidate, FP-100, is to evaluate human safety, it is an important step forward as it launches the development of a first therapeutic candidate specifically developed to treat early Lyme disease”, said Matt Tindall, the company’s co-founder and Chief Executive Officer. “This is a watershed moment as it sets the example for how new therapeutic candidates begin to move toward the large unmet medical need in Lyme. If successful, this study would be followed by a phase II study of FP-100’s safety and efficacy in acute Lyme disease patients. These advances would not be possible without the ongoing financial support of our foundation partners, led by The Steven & Alexandra Cohen Foundation, Bay Area Lyme Foundation and Global Lyme Alliance.”

For the past 9 years, Flightpath Biosciences’ co-founding Scientist, Kim Lewis, PhD, Director of the Antimicrobial Discovery Center at Northeastern University, has sought to identify a compound acting selectively against a particularly destructive spirochetal pathogen, Borrelia burgdorferi. After screening for compounds specifically acting against this pathogen, Dr Lewis identified a compound, FP-100 (hygromycin A), that was highly selective against spirochetes, including B. burgdorferi, but did not harm healthy gut bacteria. As a result, he and his collaborators believe this selective antibiotic holds the promise of providing a better therapeutic for Lyme disease. The unique mechanism of selectivity of this drug represents a potential breakthrough in targeted treatment options for the disease (Cell, Leimer et al).

“Unfortunately, when Lyme patients take broad-spectrum antibiotics, the drugs can wipe out good bacteria in the body’s sensitive gut microbiome, leading to other serious symptoms” said Dr Lewis. “With FP-100 we are seeking to change the treatment paradigm and hopefully yield better long-term outcomes with a selective approach to treating the disease.”

Promising Opportunities for Additional Impact with FP-100

“In addition to this exciting advance in Lyme disease, our team and collaborators have conducted multiple proof-of-concept studies against the driver-pathogens in alternate disease areas (e.g. syphilis, oral health, women’s health and cancer) and we now have ample evidence that FP-100 could be a ‘pipeline-in-a-pill’, blockbuster drug,” said Mark de Souza, co-founder and Flightpath’s Executive Chairman. “As a result, we continue to add to our world-class team and Scientific Advisory Board and are seeking additional development partnerships. As an example, last year, the Company announced a landmark Collaboration Agreement with the ADA Forsyth Institute to develop FP-100 to treat periodontal disease. Stay tuned.”

For more information on Flightpath’s phase I clinical study, please visit the ANZCTR website.

Flightpath Biosciences forward looking statements

This written announcement contains forward-looking statements, identified by the use of words such as “believes,” “expects,” “may,” “will,” “should”, “potential,” “anticipates,” “plans” or “intends” and similar expressions. Such forward-looking statements involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in this announcement. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of and future demand for Flightpath Biosciences’ products and the impact of competitive products and pricing. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Flightpath Biosciences does not intend to update this information.

About Steven & Alexandra Cohen Foundation

The Steven & Alexandra Cohen Foundation is committed to inspiring philanthropy and community service by creating awareness, offering guidance, and leading by example to show the world what giving can do. The Foundation’s grants support nonprofit organizations based in the United States that either help people in need or solve complex problems. The Foundation also spearheads grassroots campaigns to encourage others to give.

About Flightpath Biosciences, Inc

Flightpath Biosciences, Inc is a private, clinical-stage life sciences company. The company’s lead drug candidate, FP-100, is an orally-bioavailable, narrow-spectrum bactericidal compound with selective activity against Borrelia burgdorferi (e.g. Lyme disease) and Treponemes (e.g. syphilis and gum disease) as well as known pathogenic strains of Fusobacterium nucleatum (e.g. bacteria implicated in CRC, OSCC and various women’s health issues – endometriosis, infertility, pre-term birth and stillbirth), with limited impact on the gut microbiome. As such, in addition to Lyme disease, FP-100 is being developed as a “pipeline-in-a-product” in multiple diseases and therapeutic areas. Headquartered in Detroit, MI, Flightpath is building a world-class biotechnology company by combining an experienced team with innovative targeted therapeutic approaches and scientific rigor to address the significant and growing infectious disease challenges impacting society.

For more information, visit www.flightpath.bio and follow us on LinkedIn. 

CONTACTS

Media Relations:

Lindsy Swift
Director of Marketing and Communications
Global Lyme Alliance
203-883-6834
marketing@gla.org

For Non-Clinical Inquiries Regarding Investor Relations, Business Development & Partnerships:

Matt Tindall
CEO
info@flightpath.bio

 

 

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