SAN DIEGO, Aug. 21, 2017 (GLOBE NEWSWIRE) -- MatriSys Bioscience, a leader in the field of microbiome-based therapeutics for the treatment of skin conditions, today announced that the first patient has been dosed in a Phase 2A clinical study of an investigational therapy in adults with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to examine the safety and effectiveness of a new therapy - a commensal lotion containing infection fighting bacteria, on decreasing or eliminating Staph. aureus found on the skin of AD patients.
This study is enrolling over 50 patients to evaluate the tolerability, safety and efficacy of a preparation of “universal” live biologic therapeutic Staphylococcus hominis strain A9 administered topically twice a day for 7 days to AD lesions. This Atopic Dermatitis Research Network (“ADRN”) led study is sponsored by the National Institute of Allergy and Infectious Diseases (identifier NCT03151148).
Atopic dermatitis, also known as atopic eczema, is a non-contagious, chronic inflammatory skin condition with a worldwide prevalence of 15-20% in children and 1-3% in adults. It is a serious disease characterized by painful itching, cutaneous dryness, widespread rash, and sleep-related problems. AD adversely affects everyday life in a majority of patients and causes significant distress to both patients and their families. Unlike healthy skin, the skin of AD patients is frequently colonized by Staphylococcus aureus (S. aureus). Colonization of S. aureus on AD skin is strongly linked to increased severity of the disease.
“As existing treatment options for AD have limited efficacy, we are looking forward to exploring the potential of this microbiome-based therapeutic for the treatment of 18 million Americans suffering from AD,” said Mark S. Wilson, CEO of MatriSys Bioscience. “This approach is a dramatic improvement over broad-spectrum antibiotics that destroy pathogenic bacteria but also kill the beneficial ones and allow harmful pathogens like S. aureus to colonize the skin more effectively, which often results in debilitating infections and additional antibiotic treatments. S. hominis A9 is a harmless commensal skin bacteria that produces potent anti-Staph. aureus antimicrobial peptides. Thus, by exploiting the properties of S. hominis A9, it is possible to specifically kill S. aureus while sparing the remaining beneficial microflora of the patient.”
Phase 2 Clinical Trial Design
UCSD Professor Richard L. Gallo and his colleagues have previously shown that application of a lotion containing rationally selected bacteria dramatically decreased S. aureus abundance in the lesions of AD patients. A previous, small Phase I clinical trial in which AD patient’s own bacteria with antimicrobial activity were grown and formulated in a skin lotion that was applied once to the forearm of the same patient, resulted in a dramatic decrease of S. aureus without damage to other beneficial bacteria. (Nakatsuji et al. Sci Transl Med. 2017 Feb 22;9(378).
The Phase 2 clinical trial announced today is double-blind, randomized, and placebo-controlled. Approximately 50 eligible atopic dermatitis patients at National Jewish Health General Clinical Research Center in Denver, CO, and the University of California in San Diego will be randomized (2:1) to be dosed with a lotion containing S. hominis A9 twice daily or placebo for 1 week. The primary efficacy endpoint measures are the count of serious and non-serious treatment emergent adverse events. The secondary outcome measures include the occurrence of at least one serious or non-serious treatment emergent adverse event, the eczema area and severity index (EASI) score, the scoring atopic dermatitis (SCORAD) score, and the pruritus visual analog scale (VAS) score. Additionally, change in the bacterial abundance of live Coagulase Negative Staphylococcal Species (CoNS) post one week of lotion treatment, and time to first recurrence of S. aureus are assessed. Other outcome measures also include identification of lesional and non- lesional skin microbiome by DNA sequencing, and microbiome transcriptome by RNA sequencing after 1 week of treatment. Participants will be followed through day 38 to asses for safety and disease status. For additional detail, please refer to https://clinicaltrials.gov/ct2/show/NCT03151148.
About MSB-01
MatriSys Bioscience is currently developing MSB-01 which is a commercially viable room-temperature stable topical formulation of freeze-dried S. hominis A9 bacteria in an anhydrous oil for application to the lesional skin of AD patients. The lyophilized bacteria are revived in the presence of skin moisture, and kill S. aureus that colonize the patients’ skin. MSB-01 is expected to enter clinical trials in mid 2018.
About MatriSys Bioscience
MatriSys Bioscience is a clinical stage Specialty Biopharmaceutical Company focused on developing and commercializing rational microbiome therapies for the top five dermatology and skin care conditions. Our foundational microbiome therapeutics platform is based on the pioneering work of Richard L. Gallo MD PhD, Distinguished Professor and Founding Chair, Department of Dermatology at the University of California, San Diego and the http://gallolab.ucsd.edu/. For more information, please visit http://www.matrisysbio.com/.