Silo Pharma Inc Stock Price, News & Analysis

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.

Silo Pharma (SILO) announced positive results from sterilization and dissolution tests of its SP-26 ketamine-loaded implant for fibromyalgia and chronic pain. The tests, conducted under a development agreement with Sever Pharma Solutions, showed the implant achieved over 80% drug release over a 7-day period with consistent delivery. The implants demonstrated minimal variation in physical properties, indicating safety and stability. The company plans to proceed with animal studies to evaluate the efficacy of these dose-controlled, time-release implants for fibromyalgia and chronic pain treatment.

Silo Pharma (Nasdaq: SILO) has completed a pre-IND meeting with the FDA regarding SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorder. The company proposed a 505(b)(2) regulatory pathway for approval, which could shorten clinical timelines and reduce development costs. The FDA provided written responses, giving Silo a clear path to advance SPC-15 into human trials.

Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study before submitting an IND for a potential first-in-human clinical trial. Pre-clinical data suggests SPC-15 has additive benefits for combating stress-induced pathophysiology. Silo has an exclusive license from Columbia University to develop, manufacture, and commercialize SPC-15 worldwide.

Silo Pharma (NASDAQ: SILO) has expanded its development agreement with Sever Pharma Solutions for its novel ketamine-based injectable implant, SP-26, targeting chronic pain and fibromyalgia. The collaboration aims to scale-up extrusion processes and continue analytical testing for this non-opioid treatment. SP-26 is a dissolvable ketamine-loaded implant designed for time-released, dose-controlled delivery.

CEO Eric Weisblum expressed satisfaction with the ongoing partnership, highlighting that Sever Pharma has been instrumental in earlier production and delivery system validation. This expanded agreement is expected to bring Silo closer to selecting the optimal final dosage and formulation for animal studies. If clinically successful, SP-26 could potentially qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval, potentially expediting its market entry.