Flightpath Biosciences Begins Dosing of Hygromycin A in Phase I Trial

Flightpath Biosciences doses first healthy participants in phase I trial of hygromycin A for treating early Lyme disease

Overview

Flightpath Biosciences Inc, a clinical-stage life sciences company developing therapeutics to treat infectious diseases, has announced 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.

Awarenwss for Lyme Disease

• 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 US, 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.

Words from CEO: Flightpath Biosciences

• "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.""

Flightpath Biosciences: Behind the making of FP-100

• For the past 9 years, Flightpath Biosciences' co-founding Scientist, Kim Lewis, 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).

Advantages of FP-100

• "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.""

Words from Chairman: Flightpath

• "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.

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