Blog: SYNTHETIC BIOLOGICS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

Item 7.01. Regulation FD Disclosure.

On May 10, 2022, Synthetic Biologics, Inc. (the “Company”) issued a press
release announcing positive safety data from its Phase 1, placebo-controlled,
double-blind multiple ascending dose (MAD) clinical trial of SYN-020 intestinal
alkaline phosphatase (IAP). 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. Each cohort included six subjects who received SYN-020 and two who received
placebo. Analyses of preliminary data demonstrated that SYN-020 maintained a
favorable safety profile and was well-tolerated across all dose levels. There
were a few treatment-related adverse events, and all were mild (grade 1) and
resolved without medical intervention. 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. No adverse event led to
discontinuation of the study drug and there were no serious adverse
events. SYN-020 levels were below the limit of quantitation in all plasma
samples at all timepoints during the study.

The information in this Item 7.01 and in the press release furnished as Exhibit
99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)
of the Securities Act of 1933, as amended and shall not be incorporated by
reference into any filing with the U.S. Securities and Exchange Commission made
by the Company, whether made before or after the date hereof, regardless of any
general incorporation language in such filing.

The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K
includes “safe harbor” language pursuant to the Private Securities Litigation
Reform Act of 1995, as amended, indicating that certain statements contained
therein are “forward-looking” rather than historical.


Item 8.01.  Other Events.


On May 10, 2022, the Company issued a press release announcing positive safety
data from its Phase 1, placebo-controlled, double-blind multiple ascending dose
(MAD) clinical trial of SYN-020 intestinal alkaline phosphatase (IAP). 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. Each cohort included six subjects who
received SYN-020 and two who received placebo. Analyses of preliminary data
demonstrated that SYN-020 maintained a favorable safety profile and was
well-tolerated across all dose levels. There were a few treatment-related
adverse events, and all were mild (grade 1) and resolved without medical
intervention. 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. No adverse event led to discontinuation of the study drug and there
were no serious adverse events. SYN-020 levels were below the limit of
quantitation in all plasma samples at all timepoints during the study.

Item 9.01. Financial Statements and Exhibits.




 (d) Exhibits.




Exhibit
 Number    Description
  99.1       Press Release issued by Synthetic Biologics, Inc., dated May 10, 2022
  104      Cover Page Interactive Data File (embedded within the XBRL document)

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