Welcome to our dedicated page for Silo Pharma news (Ticker: SILO), a resource for investors and traders seeking the latest updates and insights on Silo Pharma stock.
Overview
Silo Pharma Inc. is a developmental stage biopharmaceutical company that develops innovative therapeutics by merging traditional formulations with advanced psychedelic research. The company is dedicated to addressing underserved conditions including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. Through its unique approach, Silo Pharma focuses on both traditional and psychedelic treatment modalities to provide novel solutions where unmet medical needs persist.
Therapeutic Programs and Drug Delivery Systems
Silo Pharma is actively progressing a broad portfolio of therapeutic programs, each aimed at targeting specific medical indications:
- SPC-15: An intranasal serotonin 5-HT4 receptor agonist designed for treating post-traumatic stress disorder (PTSD) and stress-induced anxiety disorders. Leveraging biomarker-driven research, SPC-15 utilizes a non-invasive delivery method for rapid therapeutic onset.
- SP-26: A ketamine-based, time-release polymer implant developed to manage chronic pain conditions such as fibromyalgia. This innovative implant is designed to provide consistent, dosage-controlled pain relief through a minimally invasive subcutaneous procedure.
- Additional programs include preclinical assets targeting CNS disorders such as Alzheimer’s disease and multiple sclerosis, which further underscore the company’s comprehensive approach to neurological challenges.
Research Collaborations and Intellectual Property
Silo Pharma conducts its research and development through strategic collaborations with world-class medical research partners and universities. By partnering with renowned institutions, the company ensures robust scientific validation and leverages cutting-edge research in its clinical development pathways. An important component of its business model is a focused intellectual property strategy that reinforces patent protection for its lead assets, thereby safeguarding its innovations in drug delivery and therapeutic formulations.
Innovation in Drug Formulations and Delivery
At the core of Silo Pharma's strategy is the development of novel drug delivery systems. Its innovative approach encompasses:
- The use of intranasal formulations which provide a convenient and rapid therapeutic option for stress-related disorders.
- Advanced polymer-based implants ensuring sustained and controlled drug release, which is critical for chronic conditions such as fibromyalgia.
- Exploration of dual-action pharmacological approaches combining different receptor targets to enhance therapeutic efficacy without compromising safety.
Market Position and Operational Philosophy
Although Silo Pharma operates at a developmental stage, its scientifically rigorous and research-driven approach places it strategically within the biopharmaceutical industry. The company prioritizes collaborations with leading research institutions and maintains a strong emphasis on ensuring that its technologies meet regulatory safety profiles. This methodical progression from preclinical research through to clinical evaluation highlights its commitment to developing treatments that have the potential to transform patient care in areas with limited therapeutic options.
Commitment to Research Excellence
Silo Pharma is anchored on principles of expertise, authoritativeness, and trustworthiness. Its research is designed to resolve significant medical challenges with precise, mechanism-based therapies. By continuously enhancing its array of novel formulations and robust drug delivery systems, the company exemplifies a balanced approach, integrating rigorous scientific research with practical therapeutic solutions.
Silo Pharma (Nasdaq: SILO) has announced a significant milestone in the development of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). The company has initiated first dosing in an IND-enabling GLP-compliant toxicology and toxicokinetics study.
Following a successful pre-IND meeting with the FDA in September 2024, Silo is pursuing the 505(b)(2) regulatory pathway for SPC-15's approval. This pathway is designed to potentially reduce clinical development timelines and costs. The current studies, if successful, will provide the final preclinical data required for submitting an IND application and advancing to first-in-human clinical trials.
Silo Pharma (Nasdaq: SILO) has secured a new U.S. patent (projected number 12,239,614) for its lead asset SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The patent, titled 'Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females,' will be issued on March 4, 2025.
This patent builds upon previously issued U.S. Patent 11,491,120 from November 2022, adding new claims and strengthening the company's intellectual property portfolio. The development supports Silo's collaborative research with Columbia University and advances their efforts toward clinical trials for SPC-15.
Silo Pharma (NASDAQ: SILO) has filed a new provisional patent application with the USPTO for its lead asset SPC-15, expanding its intellectual property portfolio. The patent covers a dual-action method and composition for treating stress-induced psychiatric disorders.
A preclinical study demonstrated that the combination of SPC-15, a serotonin type IV receptor (5-HT4R) agonist, with an N-methyl-D-aspartate receptor (NMDAR) antagonist showed significant improvements in behavioral outcomes and reduced severe stress-induced conditions. This technology was originally licensed through a collaboration with Columbia University.
The company has also recently filed a separate expanded provisional patent application focusing on chronic, combinatorial targeting of NMDARs and 5-HT4Rs to extend behavioral effects against stress-induced perseverative behavior and hyponeophagia.
Silo Pharma (NASDAQ: SILO) reported positive initial results from its ongoing study of SP-26, a novel ketamine extended-release rod implant designed for chronic pain and fibromyalgia treatment. The non-GLP small animal testing, which began in December 2024, showed no serious side effects or discomfort following implantation in early January 2025.
The SP-26 implant is being developed as a self-administered, non-opioid therapeutic. The study is currently in the final stages of Absorption, Distribution, Metabolism, and Excretion (ADME) testing, with final safety and pharmacokinetic reports expected in March 2025.
Silo Pharma (NASDAQ: SILO) has filed a provisional patent application with the USPTO for its lead asset SPC-15, targeting treatments for stress-induced psychiatric disorders, including PTSD. The patent covers the chronic, combinatorial targeting of N-methyl-D-aspartate receptors (NMDARs) and serotonin type IV receptors (5-HT4Rs) to extend behavioral effects against stress-induced perseverative behavior and hyponeophagia.
This filing enhances Silo's intellectual property portfolio for SPC-15 technology, which was originally licensed through a collaboration with Columbia University. The exclusive agreement grants Silo global rights to develop, manufacture, and commercialize SPC-15.
Silo Pharma (NASDAQ: SILO) has received a Notice of Allowance from the USPTO for patent application 17/954,864, titled 'Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females.' This patent, expected to be formally issued within 90 days, will strengthen protection for SPC-15, the company's lead asset targeting post-traumatic stress disorder (PTSD) through intranasal delivery.
The patent includes new claims to U.S. Patent 11,491,120, which was issued to Silo in February 2023. The company holds an exclusive license agreement with Columbia University for global development, manufacturing, and commercialization rights of SPC-15, including extensive issued patents and pending IP patent applications.
Silo Pharma (NASDAQ: SILO) has issued a shareholder letter highlighting progress on its lead assets. The company plans to submit an IND application for SPC-15, an intranasal PTSD treatment, in 2025, followed by Phase 1 clinical trials. SPC-15 has shown promising pre-clinical results for PTSD, stress, and potentially eating disorders.
The company is also advancing SP-26, a ketamine implant for fibromyalgia and chronic pain, with animal testing scheduled for early 2025. Both drugs could qualify for the FDA's streamlined 505(b)(2) regulatory pathway, potentially accelerating approval timelines.
Silo has exclusive global rights to commercialize SPC-15 through a collaboration with Columbia University. The company reports a strong balance sheet with minimal debt as it advances its development programs.
Silo Pharma (NASDAQ: SILO) has initiated a pharmacokinetic (PK) and tolerability study for SP-26, its dissolvable ketamine-based injectable implant targeting chronic pain and fibromyalgia. The three-week non-GLP study, conducted in partnership with AmplifyBio, will evaluate the absorption, distribution, metabolism, and excretion of extended-release ketamine hydrochloride implants in a minipig model. Two different polymer formulations will be tested at various dose levels.
This milestone follows several previous studies including analytical testing, proof-of-concept extrusion trials, manufacturing evaluation, and sterilization tests. SP-26 is being developed as a self-administered, non-opioid therapeutic and aims to be a first-of-its-kind ketamine treatment for chronic pain.
Silo Pharma (SILO) has entered a collaboration agreement with Kymanox to develop a subcutaneous insertion device for SP-26, their ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain. The agreement includes initial proof-of-concept design followed by prototype development and feasibility testing to determine optimal tissue insertion depth. Previous testing has confirmed the optimal formulation for SP-26 implants. The company aims to develop SP-26 as a potential first-in-class at-home injectable ketamine-based therapeutic, with preclinical research focusing on FDA safety requirements. Kymanox also serves as Silo's regulatory partner for SPC-15, a treatment for stress-induced affective disorders including PTSD.
Silo Pharma (NASDAQ: SILO) announced positive preclinical study results for SPC-15, a novel dual-action treatment targeting stress-related disorders. The study combined SPC-15, a 5-HT4R agonist, with an NMDAR antagonist, demonstrating enhanced efficacy in treating stress-induced behaviors compared to single-agent treatments. The research showed significant improvements in behavioral outcomes related to severe stress-induced conditions in animal models. The company is developing SPC-15 as an intranasal prophylactic treatment for PTSD and plans to submit an IND for first-in-human trials.
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