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The Company recently consummated the acquisition of VCN Biosciences, S.L. (NYSE American: SYN) is a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. 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. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. SYN-020 is a recombinant bovine IAP formulated for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation, tighten the gut barrier to mitigate “leaky gut,” and promote a healthy microbiome. We are very encouraged by these positive Phase 1 results and look forward to SYN-020’s clinical advancement.” “We will continue to explore the therapeutic potential of SYN-020 across indications including celiac disease, NAFLD, age-related metabolic and inflammatory diseases. Shallcross, Chief Executive Officer of Synthetic Biologics. “SYN-020 is a promising, versatile asset that has the potential to become a multi-indication therapeutic capable of addressing a considerable market opportunity and unmet need for innovative, new therapies targeting disorders stemming from gastrointestinal (GI) inflammation,” said Steven A.
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This latter group of age-related clinical indications is supported by the Company’s collaboration with Massachusetts General Hospital. The Company is continuing to evaluate potential lead indications, which may include celiac disease, nonalcoholic fatty liver disease (NAFLD), and radiation enteropathy as well as indications to treat and prevent metabolic and inflammatory disorders associated with aging. Additional analyses, including fecal levels of SYN-020 and anti-drug antibody levels are on-going.īoth the previously reported Phase 1 single ascending dose (SAD) study and the current MAD study are intended to support the development of SYN-020 in multiple clinical indications. SYN-020 levels were below the limit of quantitation in all plasma samples at all timepoints during the study. No adverse event led to discontinuation of the study drug and there were no serious adverse events. The most common adverse event, constipation, occurred in three out of 24 subjects in the treatment arm and in one out of eight subjects in the placebo arm. There were a few treatment-related adverse events, and all were mild (grade 1) and resolved without medical intervention. Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile and was well-tolerated across all dose levels. Each cohort included six subjects who received SYN-020 and two who received placebo. The Phase 1 MAD study enrolled 32 healthy adult volunteers into four cohorts with SYN-020 administered orally in doses ranging from 5 mg to 75 mg twice daily for 14 days with a follow-up evaluation at day 35.
#Positive syn trial#
(NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced positive safety data from its Phase 1, placebo-controlled, double-blind multiple ascending dose (MAD) clinical trial of SYN-020 intestinal alkaline phosphatase (IAP).
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ROCKVILLE, Md., (GLOBE NEWSWIRE) - Synthetic Biologics, Inc. Orally administered SYN-020 observed to be well tolerated across all doses in healthy volunteers.