Silo Pharma Achieves New Milestone for SP-26 Therapeutic -Initiates IND Enabling Study of Topical Ketamine Formulation
November 11 2022 - 7:15AM
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a
developmental stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research, today announced
initial dosing in its IND-enabling study of SP-26, its novel
time-released, topical formulation of ketamine.
The objective of this safety evaluation study, conducted by
Experimur, a Frontage Company, is to evaluate the tolerability of
the SP-26 compound to establish a maximum tolerated dose. The new
drug is intended to treat fibromyalgia, a chronic condition causing
widespread musculoskeletal pain accompanied by memory issues, sleep
problems and fatigue.
Eric Weisblum, Chief Executive Officer of Silo Pharma, stated,
“Our team is excited about this milestone in our collaboration
with our joint venture partner Zylö Therapeutics,
headquartered in South Carolina. Together we have developed a
delivery method for a new ketamine formulation that has shown in
pre-clinical studies to hold and distribute the drug in a
time-released fashion and reduce neuropathic nerve pain. This
IND-enabling study coupled with our existing data brings us another
step closer to testing in human patients.”
Silo Pharma recently began working with a regulatory partner to
prepare a pre-Investigational new drug (IND) package submission to
the U.S. Food and Drug Administration (FDA). The Company intends to
pursue the 505(b)(2) regulatory pathway for SP-26.
Silo cites that according to Fortune Business Insights, the
market for fibromyalgia treatments was valued at US$764 million in
2020 and will be worth US$1.4 billion in 2027 with a compound
annual growth rate (CAGR) of 9.2 per cent over the next five
years.1
About Silo Pharma Silo Pharma. Inc. is a
development-stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research for people
suffering from indications such as PTSD, Alzheimer’s disease, and
other rare neurological disorders. Silo’s mission is to identify
assets to license and fund the research which we believe will be
transformative to the well-being of patients and the healthcare
industry. For more information, visit www.silopharma.com.
Forward-Looking Statements All statements other
than statements of historical fact in this announcement are
forward-looking statements that involve known and unknown risks and
uncertainties and are based on current expectations and projections
about future events and financial trends that the Company believes
may affect its financial condition, results of operations, business
strategy, and financial needs. Investors can identify these
forward-looking statements by words or phrases such as "may,"
"will," "expect," "anticipate," "aim," "estimate," "intend,"
"plan," "believe," "potential," "continue," "is/are likely to" or
other similar expressions. The Company undertakes no obligation to
update forward-looking statements to reflect subsequent occurring
events or circumstances, or changes in its expectations, except as
may be required by law. Although the Company believes that the
expectations expressed in these forward-looking statements are
reasonable, it cannot assure you that such expectations will turn
out to be correct, and the Company cautions investors that actual
results may differ materially from the anticipated results and
encourages investors to review other factors that may affect its
future results in the Company's filings with the SEC.
Contact 800-705-0120investors@silopharma.com
1 Fortune Business Insights; Fibromyalgia Treatment Market
Size, Share and Trends. September 2022.
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