subslover
2月前
Silo Pharma Issues Letter to Shareholders Detailing Development Progress and Potential for Lead Assets Targeting PTSD and Chronic Pain
IND submission for intranasal SPC-15 treatment expected in 2025; Phase 1 clinical trial to follow upon approval
SP-26 ketamine implants nearing first animal studies
SARASOTA, FL, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” “we,” “us,” “our,” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today issued a letter to shareholders highlighting the Company’s progress and potential for its lead assets SPC-15 and SP-26 as treatments for mental health and chronic pain management, respectively. The letter, in its entirety, is reprinted below.
Dear fellow Silo Pharma shareholders,
Silo Pharma is gaining momentum along its path to first-in-human trials for lead candidate SPC-15, an intranasal prophylactic targeting PTSD and stress induced anxiety disorder. We are currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study and believe this will be the final data required before we submit an investigational new drug (IND) application to the FDA. I’m proud to report that we are getting closer to in-human trials.
In addition to SPC-15, we are advancing development of our SP-26 ketamine implant and continuing studies of our other investigational drugs. Each of these novel and potentially transformative therapies are tied to exclusive collaborations with world-class medical research partners, bringing valuable IP, assets and time-to-market advantages for Silo.
Through our ongoing commitment to developing novel therapeutics that address underserved conditions, Silo has created a robust platform of innovative solutions for mental health, chronic pain, and neurology.
SPC-15 | Intranasal PTSD Treatment
For our lead program, SPC-15, we completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in September 2024 regarding our development plan. The primary purpose of the meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 as we prepare for an expected IND submission in 2025, followed by a Phase 1 clinical trial in PTSD upon approval of our IND. This would be a significant milestone for Silo.
While the initial indications for SPC-15 are PTSD and stress, our pre-clinical data could also support a possible Phase 1 trial of SPC-15 as a treatment for eating disorders and anorexia. Additionally, promising results from another pre-clinical study showed that a dual-action approach of combining SPC-15, a 5-HT4R agonist, with an NMDA receptor (NMDAR) antagonist enhanced efficacy as compared to either agent alone for the treatment of major depressive disorder (MDD) and other severe stress-related conditions.
Columbia University, our collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.
SP-26 | Ketamine-Loaded Implants
We continued our progress in the development and formulation of our novel SP-26 ketamine implants targeting fibromyalgia and chronic pain during 2024, and animal testing is scheduled to begin in early 2025. The unique design and development of the subcutaneous insertion device is expected to support sustained relief of chronic pain using a viable alternative to highly addictive opioid treatments.
Preclinical research to date has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
We have initiated our first animal study to evaluate dosage, time release, and absorption of the drug, and we expect to share these results in early 2025.
Approval Pathways
If clinically successful, both SCP-15 and SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Under Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act (FDCA), drug developers can use publicly available data on active ingredients in a compound for a new drug application (NDA). This streamlined pathway allows for significantly shortened clinical timelines and reduced clinical development costs as compared to the conventional full NDA process.
We believe this strategy could simplify our clinical plans and allow for a faster approval process, potentially accelerating our delivery of effective solutions for patients with access to few, if any, proven therapeutics.
Market Trends
The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge unmet need for the treatment of these diseases, despite years of clinical research efforts across the pharmaceutical industry.1
For PTSD, there have been no new drug approvals in nearly 25 years for a condition that affects an estimated 3.9% of the world’s population.2 The Only FDA-approved drugs for fibromyalgia are two antidepressants and one anti-seizure medicine.3
Each of our neurology programs, SPC-14 for the treatment of Alzheimer’s disease and SPU-15 for the treatment of multiple sclerosis, address very large and growing markets. The Alzheimer’s disease treatment market shows projected growth to $30.8B in 2033, at 18.8% CAGR,4 and the global market for multiple sclerosis drugs is projected to grow to $38.9B by 2032, at a 7.9% CAGR.5
Creating Value
In closing, we believe our progress in 2024 sets us up for exciting developments and milestones for Silo in 2025. Our current balance sheet, with cash on hand and minimal debt, offers financial flexibility as we move forward with ongoing research and development of therapies with the potential to transform patient care.
Silo Pharma is committed to delivering compelling catalysts for value creation for our existing and future shareholders. We are enthusiastic about the future and grateful for your interest and continued support.
Sincerely,
Eric Weisblum
Chief Executive Officer
December 2024
About SPC-15
SPC-15 is a serotonin 5-HT4 receptor agonist designed to treat stress-induced disorders such as PTSD and anxiety. Delivered via an intranasal formulation, SPC-15 may qualify for the FDA’s streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process. Currently, Silo Pharma is collaborating with Columbia University on preclinical studies and holds exclusive rights to develop and commercialize SPC-15 globally.
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 and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
subslover
3月前
Silo Pharma Enters Joint Development Agreement for SP-26 Ketamine Implant Device Targeting Pain Management
Prototype development and feasibility testing underway for optimized subcutaneous delivery
SARASOTA, FL, Nov. 29, 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 a collaboration agreement with Kymanox for specialized design and development of a subcutaneous insertion device for SP-26, the Company’s ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain.
Under terms of the agreement, Kymanox will conduct an initial proof-of-concept design phase followed by full system prototype and feasibility testing to determine optimal insertion depth in tissue.
“Previous analytical testing and proof-of-concept extrusion trials have confirmed the optimal formulation for our SP-26 implants. Now we are advancing this program to develop a novel insertion device that is intended to be tested in continuing preclinical studies,” said Silo CEO Eric Weisblum. “We are pleased with the steady progress we are making with our proposed ketamine implants, which are being uniquely designed with a goal of providing sustained relief of chronic pain.”
Preclinical research to date has focused, in part, on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
In addition to the SP-26 agreement, Kymanox is Silo’s regulatory partner for SPC-15, a targeted prophylactic treatment for stress-induced affective disorders including PTSD.
About SP-26
Silo’s 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.
subslover
7月前
Silo Pharma Announces Partnership with Global CRO for Central Nervous System Homing Peptide
Silo to advance homing peptide development for initial indication in multiple sclerosis
SARASOTA, FL, Aug. 07, 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 that it has entered into an agreement with WuXi AppTec (Hong Kong) Limited, a leading global contract research organization (CRO), for a preclinical small animal study of SPU-16, a central nervous system (CNS) homing peptide targeting multiple sclerosis (MS). Silo Pharma is advancing the development of the SPU-16 liposomal homing peptide through a commercial evaluation license and option agreement with the University of Maryland, Baltimore (UMB).
The study will examine the organ/tissue specificity of the SPU-16 peptide in an experimental autoimmune encephalomyelitis (EAE) protocol, is the most commonly used experimental model for MS. The peptide’s proven ability to target inflamed epithelium suggests that it can be used as a targeted drug delivery tool to address inflammation in the spinal cord.
“We are excited to launch this new study of our novel CNS homing peptide under the management of WuXi AppTec, one of the largest CROs in Asia and globally,” said Silo CEO Eric Weisblum.1 “Designed to cross the blood-brain barrier and target damaged tissue and inflammation, SPU-16 has been shown to enhance the therapeutic effect of current and future therapeutics while decreasing the toxicity of the drugs. While we are currently investigating the peptide for MS, it could provide similar benefits for multiple neuroinflammatory pathologies.”
MS, a human inflammatory demyelinating disease, is one of the most widespread disabling neurological conditions of young adults.2 The global multiple sclerosis drugs market size is projected to grow at a compound annual growth rate (CAGR) of 7.9% from $21.2 billion in 2024 to $38.9 billion by 2032.3
subslover
8月前
Silo Pharma Secures Exclusive Global License for Alzheimer's Therapeutic
Agreement enhances Company’s intellectual property portfolio
SARASOTA, FL, July 16, 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 that it has entered into an exclusive global license agreement to further develop, manufacture, and commercialize its Alzheimer’s drug SPC-14. Silo intends to utilize the FDA’s streamlined 505(b)(2) pathway for SPC-14, which would shorten clinical timelines and reduce drug development costs.
“In our view, our exclusive license for SPC-14 gives us the potential to meet a large unmet medical need. If approved, we believe SPC-14 could bring hope and relief for many families and patients. Early pre-clinical studies have shown stress reduction and cognitive improvement,” said Silo CEO Eric Weisblum.
Silo Pharma recently announced a similar exclusive license agreement for its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
The global Alzheimer’s disease therapeutics market size is forecasted to exceed $30.8 billion by 2033, with a CAGR of 18.8% from 2024 to 2033 1 . Rising prevalence of the disease in the expanding elderly population and advancements in neurological research are expected to drive market growth.
subslover
2年前
Silo Pharma Reaches Positive Milestone with Nasal Formulation of SPC-15 For Anxiety, PTSD, and Stress-Related Disorders
Study data to determine potential delivery partners
ENGLEWOOD CLIFFS, NJ, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that it has advanced the formulation development for its therapeutic drug, SPC-15. The liquid nasal formulation will be used in SPC-15’s novel protocol intended for treatment and prevention of anxiety, PTSD, and other stress related disorders. The formulation development was in accordance with the Company’s sponsored research agreement and option with Columbia University. Linearity, accuracy, and repeatability were achieved in the feasibility study.
“The progress of our feasibility study investigating dose strengths of SPC-15 is a significant advancement in our development work with this pipeline candidate,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Results of the feasibility study will determine our selection of the manufacturing processes, and we are currently in discussions with potential delivery partners. We may also use the feasibility data for upcoming studies related to our SPC-14 therapeutic targeting Alzheimer’s disease.”
In May 2023, Silo Pharma was awarded a U.S. Patent titled “Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders,” with claims protecting the key technology behind SPC-15 and further drug discovery.
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
Garbage2Gucci
2年前
$SILO gaining traction on news #PTSD #Anxiety
Silo Pharma Commences Formulation for SPC-15 Targeting Anxiety and PTSD Stress-Related Disorders
https://finance.yahoo.com/news/silo-pharma-commences-formulation-spc-130000596.html
Data to Support Alzheimer’s Study
ENGLEWOOD CLIFFS, NJ, April 19, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq:SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that it has commenced development of a novel formulation as a targeted prophylactic treatment, designated as SPC-15, intended for stress, anxiety, and PTSD.
Development of the drug formulation is pursuant to the Company’s sponsored research agreement with Columbia University. Preclinical studies in the field suggest that SPC-15 could be a promising therapeutic target for the treatment of cognitive impairment, PTSD, and stress-related disorders.
“We are advancing our development of SPC-15 through this formulation and feasibility study investigating dose strengths and delivery,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “The SPC-15 treatment protocol predicts levels of severity or progression of stress-related disorders and their metabolomic biomarkers’ response to pharmacological treatments. Based on our own research to date coupled with published preclinical data, we believe SPC-15 could have a profound impact on treating stress and anxiety disorders including PTSD, we will further use this data to help us with our upcoming studies related to SPC-14 Alzheimer’s asset.”
Targeted by SPC-15, anxiety, PTSD, and other stress-related disorders are becoming more frequent in Americans aged 18+. According to the World Health Organization in 2019, 300+ million people were living with an anxiety disorder, and according to the National Center for PTSD, around 12 million adults in the U.S. alone are reported to have PTSD., According to Fortune Business Insights, the global treatment market size for anxiety disorders and depression is projected to reach $13.0 billion in 2027.
Silo Pharma was recently granted a U.S. patent covering SPC-15 as a method for the treatment and prevention of stress-induced affective disorders in females.
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
800-705-0120
investors@silopharma.com
World Health Organization; Mental disorders. June 2022.
U.S. Department of Veterans Affairs, PTSD: National Center for PTSD; How Common Is PTSD in Adults?
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