• Silo Pharma recently provided an update on an ongoing study delving into the potential use of SP-26 as an alternative treatment for fibromyalgia
• The study, which is being carried out in conjunction with Experimur, has looked into the feasibility of using a time-released, dosage-controlled formulation of ketamine as a suitable treatment for the chronic medical condition
• Since its founding, Silo Pharma has rapidly gained a reputation for its innovative approach towards seeking solutions to address a variety of underserved medical conditions

Silo Pharma (NASDAQ: SILO), a developmental stage biopharmaceutical company focused around merging traditional therapeutics with psychedelic research, recently announced that it had achieved a positive outcome for its toxicology study of SP-26, its novel time-released, dosage-controlled formulation of ketamine. The results come after Silo Pharma had previously revealed that it was working on the preparation of a pre-Investigational New Drug (“IND”) package and meeting request with the US Food and Drug Administration (“FDA”) for a novel formulation of ketamine destined towards the treatment of fibromyalgia (https://ibn.fm/X5GM4).

At the time, Eric Weisblum, Silo Pharma’s Chief Executive Officer had remarked on the company’s efforts, “We are confident that our highly constructive pre-clinical work on SP-26 will offer strong support for our pre-IND package as we seek to advance our time-released ketamine delivery system into the clinic” (https://ibn.fm/tHFlD).

Fibromyalgia is a chronic condition causing pain to the connective tissues through the body including muscles, ligaments and tendons. Musculoskeletal pain is often accompanied by sleep difficulties, fatigue, mood disorders and problems with memory and concentration. Despite having over four million Americans living with fibromyalgia, there is relatively little known about this condition, and no apparent physical cause has been identified thus far. As of 2020, the FDA had approved three drugs specifically for treating fibromyalgia, however these have primarily been destined towards the treatment of specific symptoms, such as depression or nerve pain, rather than acting as a more holistic treatment (https://ibn.fm/k1mMN).

Now and in collaboration with Experimur, a Frontage Laboratories company, Silo Pharma have provided an update as to their efforts in producing a ketamine-based treatment for fibromyalgia. The company detailed in a recent announcement that it had tested SP-26 in a toxicology and tolerability study in mini pigs using an ascending (descending) dosing regimen. The study was carried out in adherence to the bioanalytical methods required to perform toxicology studies by the U.S. Food and Drug Administration (“FDA”) in advance of initiating clinical studies for SP-26.

“Today’s positive results are an important step as we move closer to achieving all needed components to plan human trials of SP-26.” remarked Weisblum. “We are advancing our work with our regulatory partners to prepare a Pre-Investigational New Drug (‘IND’) package for SP-26 and intend to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.”

Originally founded in 2010, Silo Pharma has rapidly earned a reputation in recent years for its ground-breaking research into conditions such as post-traumatic stress disorder (“PTSD”), fibromyalgia, Alzheimer’s disease, Parkinson’s disease, and other rare neurological disorders. In addition to its recent research into potential fibromyalgia treatment alternatives, Silo Pharma have also been involved in a number of studies designed to develop innovative solutions for previously underserved conditions, including exploring the use of a prophylactic treatment for drug-resistant depression and delving into the effects of psilocybin on inflammation, among several other initiatives.

For more information, visit the company’s website at www.SiloPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to SILO are available in the company’s newsroom at https://ibn.fm/SILO

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