On August 3, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, reported an amendment to the Company’s option for an exclusive license with Massachusetts General Hospital ("MGH") to include intellectual property ("IP") and technology related to the use of SYN-020 intestinal alkaline phosphatase ("IAP"), the Company’s proprietary recombinant version of bovine IAP, to inhibit liver fibrosis in select diseases, including nonalcoholic fatty liver disease ("NAFLD") (Press release, Synthetic Biologics, AUG 3, 2021, View Source [SID1234585629]).
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Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)
Synthetic Biologics previously announced an option agreement with MGH to negotiate an exclusive license to IP and technology for the use of SYN-020 to prevent and treat metabolic and inflammatory diseases associated with aging. The option agreement has now been expanded to include technology developed by MGH to use SYN-020 to inhibit liver fibrosis in select diseases, including NAFLD. If executed, the license agreement would further strengthen the SYN-020 portfolio and build upon the Company’s intention to pursue SYN-020 for the treatment of NAFLD, and, in particular, to slow the course of fibrosis associated with progressive disease.
"We are pleased to announce the expansion of our collaboration with Massachusetts’s General Hospital and share their enthusiasm for SYN-020’s potential to address diseases associated with liver fibrosis such as nonalcoholic fatty liver disease," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We continue to view SYN-020 as a potential platform therapeutic that has a remarkable opportunity to address a considerable unmet need for innovative new therapies targeting GI disorders stemming from immune and inflammatory responses."
Under the terms of the amended agreement, Synthetic Biologics is granted an option to negotiate an exclusive worldwide license with MGH to commercially develop SYN-020 to treat and prevent metabolic and inflammatory diseases associated with aging and fibrosis of the liver.
About SYN-020 Phase 1 SAD & MAD Clinical Trials
Synthetic Biologics recently announced the completion of patient dosing and observation of its Phase 1 single-ascending dose ("SAD") clinical trial of SYN-020 in 24 healthy adult volunteers. Results from this trial demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. No serious adverse events were reported. A second Phase 1 multiple-ascending dose ("MAD") clinical trial of SYN-020 in healthy adult volunteers is expected to commence during the third quarter of 2021 with topline results anticipated during the second quarter of 2022. Both Phase 1 SAD and MAD studies are intended to support the development of SYN-020 in multiple potential clinical indications, including celiac disease, radiation enteropathy, metabolic and inflammatory disorders associated with aging, and to inhibit fibrosis in select diseases, including NAFLD.
About SYN-020 Intestinal Alkaline Phosphatase (IAP)
SYN-020 is a recombinant bovine Intestinal Alkaline Phosphatase (IAP) formulated for oral delivery to the small intestine. The published literature indicates that IAP functions to diminish intestinal inflammation, tighten the gut barrier to diminish "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has the ability to produce SYN-020 at a scale and cost viable for clinical and commercial development. Synthetic Biologics is currently developing SYN-020 in multiple potential clinical indications, including celiac disease, nonalcoholic fatty liver disease (NAFLD), radiation enteritis, and indications to treat and prevent metabolic and inflammatory disorders associated with aging.