SARASOTA, FL - Silo Pharma Inc. (NASDAQ:SILO), a biopharmaceutical company, has initiated steps towards clinical trials for its PTSD treatment, SPC-15, by submitting a pre-Investigational New Drug (pre-IND) briefing package and requesting a meeting with the U.S. Food and Drug Administration (FDA).
This action follows recent non-GLP small animal studies that suggest SPC-15's potential effectiveness in treating post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder through intranasal administration.
The company's CEO, Eric Weisblum, expressed confidence in the preclinical work and the supportive published data, which he believes will underpin the development strategy and initial clinical trial designs. Silo Pharma anticipates that the FDA's feedback will be instrumental as they prepare for human trials.
SPC-15, which targets the serotonin 4 (5-HT4) receptor, represents a different approach compared to the two existing FDA-approved PTSD treatments that focus on the depressive aspects of the condition. Silo Pharma's treatment aims to enhance stress resilience, particularly in populations at high risk. If successful in clinical trials, SPC-15 could be eligible for the FDA’s 505(b)(2) regulatory pathway, which allows for a more streamlined drug approval process.
Upcoming stages in the development of SPC-15 include a progressive intellectual and neurological deterioration (PIND) study and a good laboratory practice (GLP) study, both scheduled for the second half of 2024. These are necessary precursors to an Investigational New Drug (IND) application with the FDA.
Silo Pharma is collaborating with Columbia University under a sponsored research agreement and expects to secure an exclusive license to develop, manufacture, and commercialize SPC-15 globally. Finalization of this license agreement is anticipated in the first half of 2024.
Silo Pharma's portfolio also includes SP-26, a time-release ketamine-loaded implant for fibromyalgia and chronic pain, as well as preclinical programs targeting Alzheimer’s disease and multiple sclerosis. The company's research and development efforts involve partnerships with academic institutions such as Columbia University and the University of Maryland, Baltimore.
This report is based on a press release statement. Silo Pharma's forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. The company does not undertake any obligation to update these statements in the event of new information or future developments.
In other recent news, Silo Pharma has made significant strides in its research and development efforts. The biopharmaceutical company has reported promising results from a study on a new drug formulation for depression treatment, conducted in collaboration with Columbia University. The innovative formulation targets previously unexplored biochemical pathways related to mood regulation, potentially improving mood stability and extending remission periods for depression patients.
In line with its focus on developing groundbreaking therapies, Silo Pharma has completed the pre-clinical development of SPC-15, a program for PTSD, and is preparing for a pre-investigational New Drug Application to the FDA. The company has also secured licenses for Alzheimer's disease therapeutic, SPC-14, and PTSD treatment, SPC-15, from Columbia University, which are expected to be finalized in the first half of 2024.
Furthermore, Silo Pharma will participate in an FDA-sponsored public meeting to discuss the use of ketamine in emerging therapeutic areas. The company is currently developing several drug candidates that feature ketamine as a primary therapeutic agent, including SP-26, a time-release ketamine-loaded implant for pain relief. These developments underscore Silo Pharma's commitment to exploring novel formulations and delivery systems for drugs that address conditions with limited treatment options.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.