GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.
Mayo Clinic is collaborating with APT to conduct a clinical trial using PhageBankTM investigational therapy to address the significant unmet need for alternative treatments for chronic infections following joint replacement (referred to as “periprosthetic joint infections,” or “PJIs”). Proceeds from the convertible note are designated to initiate the trial.
“Prosthetic joint infection is a potential complication of joint replacement implantation that can be very serious and lead to loss of life or limb. As we face a growing public health threat from drug-resistant bacterial infections, we need more research to assess phage therapy’s potential to help people with these infections and save lives,” said Gina Suh, M.D., infectious diseases specialist and one of the experts at Mayo Clinic leading the research collaboration with APT.
APT has supported Mayo Clinic physicians in the treatment of multiple patients with end-stage chronic PJIs under emergency use approvals by the US Food and Drug Administration (FDA). In each case, the patient faced serious challenges due to chronic and refractory infections unresponsive to commercially approved therapies following knee replacement implantations. Use of APT’s PhageBank in lieu of surgery is often referred to as the “Haverty Protocol,” in recognition of John Haverty, the first PJI patient treated with investigational PhageBank therapy at Mayo Clinic. The research is published in the July issue of Clinical Infectious Diseases (CID).
APT anticipates initiating the PJI trial at Mayo Clinic in the fall of 2020. If successful, the company anticipates potential commercial availability in 2023. Based on an international survey of hospital payers and doctors, conducted by Triangle Insights Group, it is estimated that APT’s PhageBank treatment of PJI represents a commercial market of more than $900 million per year.
“APT is pleased that Mayo Clinic recognizes the value of phage therapy and its role in treating chronic PJI infection. Current standard of care can cost up to $400k per patient and often results in five-year mortality rates comparable to those of colon cancer,” said Greg Merril, co-founder and chief executive officer, Adaptive Phage Therapeutics.
Last month, APT announced a collaboration with Mayo Clinic to advance and commercialize a phage susceptibility test (PST) to be offered as a laboratory developed test for worldwide commercial availability by Mayo Clinic Laboratories. PST will enable rapid identiﬁcation of patient-speciﬁc precision therapy for challenging bacterial infections.
Mayo Clinic and Dr. Suh have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
About Antimicrobial Resistance (AMR)
According to the Centers for Disease Control, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result.1 The World Health Organization estimates that superbugs will kill up to 10 million people globally each year by 2050.2 Thirty-five percent of common human bacterial infections are already resistant to currently available medicines in some high-income countries.3
According to the World Health Organization, there is a US $100 trillion potential cost in terms of lost global production between now and 2050.4 The indirect costs of drug-resistant infections to the individual and society from morbidity, disability, premature deaths and reduced effective labor supply are estimated to cause a decrease in the global economic output of 1–3% by 2030, with estimated losses ranging from US $1 trillion to US $3.4 trillion annually if no action is taken.5
About Periprosthetic Joint Infections (PJI)
Periprosthetic joint infections (PJIs), are infections involving a joint prosthesis and adjacent tissue, which develop following a joint replacement implantation. PJIs have been projected to occur in approximately two percent of joint replacement surgeries performed. Risk factors for PJI include co-morbidities of obesity, diabetes or rheumatoid arthritis, among others. PJI is known to occur more frequently in revision surgeries, and the majority of PJIs occur within one year of surgery. The economic impact to the healthcare industry is projected to reach more than $1.62 billion in 2020. PJIs are painful and create a tremendous burden for individual patients.9
Bacteriophage (“phage”) are viruses that host on bacteria. Phage have evolved to become the most prolific killers of bacteria on earth. Phage have been used for clinical applications since their initial discovery at the beginning of the twentieth century. The ability of phage to replicate exponentially and kill bacteria suggests that they could play a vital role in our armamentarium for the treatment of infectious diseases.8 There are an estimated 10 phage for each bacteria on earth, and each phage strain has evolved to eradicate a narrow range of bacteria. The introduction of penicillin in the 1940s displaced interest in commercial development of phage. With the growing crisis of bacterial resistance to antibiotics, there has been renewed interest in phage therapy.
PhageBank is an ever-expanding collection of genetically diverse, carefully screened, and purified phage that are collectively broad spectrum, negating the effects of bacterial resistance that increasingly diminish the effectiveness of antibiotics. In 2017, APT acquired world-wide exclusive commercial rights to PhageBank from the biodefense program of the U.S. Department of Defense. APT is advancing the technology through innovation in bioinformatics, rapid phage-bacteria matching and phage purification methods in an approach capable of providing a precision-matched therapy based upon the diagnosis of a specific bacterial pathogen.
About Adaptive Phage Therapeutics (APT)
APT is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 23 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.
8 The prospect for bacteriophage therapy in Western medicine. Merril, Scholl, Adhya -Nature Reviews Drug Discovery, 2003