Silo Pharma (Nasdaq: SILO), a developmental-stage psychedelic biopharmaceutical firm, announced today that it has begun a preclinical toxicity study of its novel time-released, dosage-controlled ketamine formulation, designated as SP-26, for the treatment of fibromyalgia.
About Silo Pharma
Silo Pharma is a biotechnology startup that wants to combine conventional medications with psychedelic research for people suffering from conditions like post-traumatic stress disorder (PTSD), Alzheimer’s disease, and other rare neurological diseases. Silo aims to discover assets that can be licensed and financed so that important research may be done, which the company believes will benefit patients and the healthcare sector.
Silo Pharma Z-Pod Ketamine Development Partnership with Zylö Therapeutics
Silo Pharma is developing the clinical development of ketamine using ZTI’s Z-pod technology in collaboration with joint venture partner Zylö Therapeutics, Inc. (ZTI). The Company has chosen to pursue fibromyalgia as a first indication based on preclinical research showing that the Z-pod can retain and deliver ketamine in a time-released manner.
SP-26 has yielded previous positive results in lessening neuropathic nerve pain. This safety evaluation study will provide the data needed to understand what the maximum tolerated dosage is, which will be useful for our future trials.
The SP-26 compound will now be put through a series of Safety Evaluation Studies using mini pigs in an ascending (descending) dosing regimen to test its tolerability. The study’s data is estimated to become available at the beginning of 2023.
Silo Pharma is diligently working with a regulatory partner to assemble an FDA Pre-Investigational New Drug (IND) package for SP-26, a never-before-seen topical formulation of ketamine that has been officially named SPC-26. This new drug candidate is being considered as a treatment for fibromyalgia and the Company intends to gain approval through a 505(b)(2)regulatory pathway.
Ketamine Treatment for Fibromyalgia
The Winter 2021 edition of The Ochsner Journal, a peer-reviewed quarterly medical journal, published an abstract titled Systematic Review of the Use of Intravenous Ketamine for Fibromyalgia.
The Ochsner Journal is a pioneering nonpredatory, open-access publishing initiative: the Journal does not charge authors any publication fees, and the complete text of every piece is freely available online and in print. The “platinum model” of open-access publishing is well-recognized in academic publishing.
Fibromyalgia is a complex disorder that affects 1% to 5% of the population and manifests as widespread chronic musculoskeletal pain without any physical or laboratory signs of a specific pathologic process.
Background
The mechanism is still being explored, but it suggests that central sensitization and disordered pain regulation at the spinal cord and supraspinal levels result in an imbalance between excitation and inhibition. This may then alter the central nervous system’s nociceptive processing.
Nociceptive hypersensitivity is a condition in which the brain and spinal cord are excessively sensitive to pain. The activity of the N-methyl-D-aspartate receptor (NMDAR)–mediated glutamatergic synaptic transmission in the spinal cord and brain causes it. The study of ketamine’s use as an intravenous medication to treat fibromyalgia has grown because it may reduce the induction of synaptic plasticity and maintenance of chronic pain states, making it an NMDAR antagonist.
Methods
The researchers conducted a literature search with the goals of investigating the impact of intravenous ketamine administration on pain relief, detecting unwanted effects, and emphasizing the necessity for clinical trials to evaluate ketamine infusion therapy protocols in patients with fibromyalgia.
The team used the keywords “fibromyalgia,” “chronic pain,” “ketamine,” “intravenous,” and “infusion” to find 7 articles including 118 people who satisfied the inclusion criteria.
Results
Clinical studies relatively recently discovered that there is a slight decrease in pain (for only a few hours after the ketamine infusion) when intravenous, low-dose ketamine infusions are administered. It’s most likely because of fibromyalgia patients’ central sensitization to nociception via NMDAR blockade.
According to case studies, administering a greater total amount of ketamine and continuing to administer it more frequently may be linked to better pain alleviation and longer-lasting analgesia. A second neurotransmitter release may be behind this result.
Conclusion
This systematic review found a dose-response relationship, suggesting that intravenous ketamine may help with fibromyalgia.
