Silo Pharma initiates a pharmacokinetic study for SP-26, a non-opioid treatment for chronic pain and fibromyalgia.
Quiver AI Summary
Silo Pharma, Inc. has announced the start of a pharmacokinetic and tolerability study for its novel, non-opioid extended-release pain therapeutic, SP-26, in collaboration with AmplifyBio. The study will examine the pharmacokinetics of a dissolvable ketamine-based injectable implant in a minipig model over three weeks. This research is a significant milestone as SP-26 is intended to safely manage chronic pain and fibromyalgia through self-administration. The company has previously conducted various studies on SP-26 and is optimistic about its potential for regulatory approval via the FDA's streamlined pathway. Silo Pharma's broader mission includes developing innovative treatments for conditions such as stress-induced psychiatric disorders and chronic pain.
Potential Positives
- Initiation of a pharmacokinetic and tolerability study for SP-26 represents a key preclinical milestone for Silo Pharma, showcasing progress in their product development pipeline.
- SP-26 aims to offer a non-opioid treatment option for chronic pain and fibromyalgia, addressing an important need in the healthcare market.
- The potential for SP-26 to qualify for the FDA’s streamlined 505(b)(2) regulatory pathway could expedite its approval process if clinically successful.
Potential Negatives
- The press release does not provide any concrete results or data from the studies conducted, which may leave investors questioning the efficacy and progress of SP-26.
- The statement includes several forward-looking statements that contain numerous risks and uncertainties, signaling potential volatility in the company's future performance.
- The fact that the study mentioned is non-GLP (Good Laboratory Practices) may raise concerns about the reliability and credibility of the research results.
FAQ
What is Silo Pharma's new pain therapeutic SP-26?
SP-26 is a dissolvable ketamine-based injectable implant designed for chronic pain and fibromyalgia treatment.
What study is Silo Pharma conducting for SP-26?
Silo Pharma has initiated a pharmacokinetic and tolerability study in minipigs to evaluate SP-26's performance.
What is the goal of the SP-26 study?
The study aims to assess the absorption, distribution, metabolism, and excretion of the extended-release ketamine implants.
How will SP-26 be administered?
SP-26 is designed as a self-administered subcutaneous implant for regulated dosage and time release of ketamine.
What potential advantages does SP-26 have over traditional pain medications?
SP-26 is a non-opioid therapy, which may reduce risks associated with opioid use in chronic pain management.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SILO Insider Trading Activity
$SILO insiders have traded $SILO stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $SILO stock by insiders over the last 6 months:
- ERIC WEISBLUM (CEO and President) has traded it 3 times. They made 3 purchases, buying 7,500 shares and 0 sales.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SILO Hedge Fund Activity
We have seen 6 institutional investors add shares of $SILO stock to their portfolio, and 7 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RENAISSANCE TECHNOLOGIES LLC added 227,006 shares (+inf%) to their portfolio in Q3 2024
- FINANCIAL ADVOCATES INVESTMENT MANAGEMENT removed 23,938 shares (-100.0%) from their portfolio in Q3 2024
- VIRTU FINANCIAL LLC removed 16,233 shares (-38.8%) from their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC added 14,582 shares (+90.1%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC added 14,373 shares (+inf%) to their portfolio in Q3 2024
- FEDERATION DES CAISSES DESJARDINS DU QUEBEC added 6,000 shares (+inf%) to their portfolio in Q3 2024
- TOWER RESEARCH CAPITAL LLC (TRC) removed 2,602 shares (-39.1%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Key preclinical milestone for novel, non-opioid extended-release pain therapeutic
SARASOTA, FL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the initiation of a pharmacokinetic (PK) and tolerability study in partnership with its contract research organization (CRO), AmplifyBio. The study is designed to assess the pharmacokinetics of Silo’s dissolvable ketamine-based injectable implant, SP-26, in a minipig model. SP-26 is being developed as a self-administered, non-opioid therapeutic aimed at treating chronic pain and fibromyalgia.
The non-GLP study, set to span three weeks, will investigate the absorption, distribution, metabolism, and excretion (ADME) of extended-release ketamine hydrochloride implants. Two distinct polymer formulations will be tested at varying dose levels.
“So far this year we have conducted several studies of our SP-26 ketamine implants including analytical testing and small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests, with what we believe are encouraging results,” said Silo CEO Eric Weisblum. “The advancement of this program into animal studies is an important milestone achievement as we work to bring a safe and effective and to our knowledge, first-of-its-kind ketamine treatment for those living with chronic pain.”
“AmplifyBio is honored to support Silo Pharma in this critical safety milestone for SP-26. We understand and take seriously the trust put in us to execute the PK study efficiently and with excellence,” said Jerry Hacker, EVP, and Chief Commercial Officer for
AmplifyBio
.
About SP-26
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with universities and independent laboratories. For more information, visit
www.silopharma.com
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Facebook
.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this news release, whether as a result of new information, future events, or otherwise, after the date of this news release or to reflect the occurrence of unanticipated events except as required by law.
Contact
800-705-0120
investors@silopharma.com
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