3 Controversial Peptides, 3 Experimental Applications

As the FDA prepares to weigh in on the bulk manufacture of our favorite experimental peptides, we decided to gather our own questions about the compounds

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Peptide bouquet, anyone?

On July 23, the FDA’s Pharmacy Compounding Advisory Committee will meet to discuss whether seven experimental peptides should be added to the 503A Bulk Drug Substances list of compounds permitted for specialized manufacture by compounding pharmacies.

Many of us in the wellness and longevity worlds – including the Secretary of Health and Human Services himself – have been known to chafe against the glacial pace of randomized controlled trials and what often feels like the monopolization by a handful of pharmaceutical manufacturers of treatments that could improve the lives of many. And while it would be naïve to assume that power and profit aren’t at stake in matters of politics and industry, it’s also naïve to assume that’s all that’s at stake. Also on the table is the nature of scientific fact and the empirical quest for the truth.

Regardless of where you stand when it comes to the clinical application of peptide therapies (and if you’re reading this newsletter, we can probably guess where you stand), it’s still important to remember that the pathway to broader peptide access will always be through good data. If you are invested in peptide research and rooting for their widespread clinical availability, then you should be rooting for more research funding and more randomized controlled trials, which are the experimental gold standard when it comes to determining the safety and efficacy of pharmaceutical drugs.

Join me, if you will, in accomplishing a rare feat of human intellect: holding two conflicting data points in your head at once. For instance, it can be true that peptides are powerful compounds and that anecdotal reports of their efficacy could be inflated by the placebo effect, as we reported last month. It can be true that there are plenty of brilliant clinicians working to bring alternative therapies to patients who’d benefit and there are clinicians who are little more than snake oil salesmen, which we’ve also reported on here at Peptide Partners Corner.

As discussion of peptides heats up in the media, it’s critical that “early adopters” (aka those of us who arrived at our interest in peptides years or even decades ago) maintain fidelity to science. Not even the most powerful drug is a miracle drug, and there’s no data set on the planet completely free of error. Reconciling your views on your favorite peptides to align with scientific findings isn’t “cope” – it’s rationalism.

And it’s in the spirit of rationalism that we’re mulling over potential experimental applications for the seven peptides currently up for debate by the FDA’s Pharmacy Compounding Advisory Committee. (And who better to speculate about good data than the peptide distributor currently leading the league in independently certified, third party-tested research peptides?)

We’ll the first 3 on the FDA’s list this week, and the remaining 4 next week. Here’s what we’d like to know about the experimental properties of BPC-157, KPV, and TB-500.

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1. BPC-157 – Angiogenesis

BPC-157 is a pentadecapeptide synthesized from a protein naturally found in human gastric juice. Its use among athletes for wound healing and musculoskeletal recovery has led to its massive popularity in the gray market and direct-to-consumer sales worlds. In 2022, the World Anti-Doping Agency (WADA) banned it from both competition and training due to its lack of human clinical approval. On July 23, the FDA will be assessing BPC-157 for its potential use in treating ulcerative colitis.

Meanwhile, researchers have observed that BPC-157 increases the production of compounds that promote angiogenesis, or the “process of new capillaries forming out of preexisting blood vessels in your body.” BPC-157’s angiogenic properties are what have made it so attractive to athletes needing to rebuild healthy tissue after injury. It’s also what has researchers concerned about long-term carcinogenesis.

A long-term study isolating BPC-157’s angiogenic properties would shed major light on this issue. Questions to answer: What are the tissue-rebuilding advantages in the short and long-term? Are there immunological risks associated with long-term therapeutic use?

2. KPV - Immunity & infection

KPV is an anti-inflammatory tripeptide produced by “the pituitary gland and various peripheral tissues.” The FDA will be assessing KPV for potential uses in wound healing and various inflammatory conditions.

Researchers who investigated KPV’s anti-inflammatory effect in epithelial and immune cells in mice noticed a “reduction in colitis indicated by a decrease in pro-inflammatory cytokine expression.” They also noticed an expression of di/tripeptide transporter Pept1 – a transporter of KPV – at the membranes of macrophages, or large white blood cells that act as the body’s defense and cleanup crew.

To better understand KPV, we need more studies that explore its potential role in fighting chronic, active infections. Questions to answer: Could KPV strengthen a weakened immune system? Would it help or harm a patient suffering from an autoimmune disorder vs. an external pathogen?

3. TB-500 – Cardiovascular angiogenesis

TB-500 is a synthetic heptapeptide designed to mimic naturally occurring Thymosin Beta-4, a protein involved in tissue repair. The FDA will be assessing TB-500 for potential applications in wound healing.

Like BPC-157, TB-500 is known for its angiogenic properties and has been used by athletes for wound healing and musculoskeletal recovery. It’s also been classified a “performance-enhancing drug” by the WADA and banned from professional athletics.

A 2021 study investigating the potential anti-aging benefits of Thymosin Beta-4 identified TB-4’s expression in the “endocardial, coronary endothelial, and epicardial cells” of developing mouse embryos as well as the mature hearts of adult mice. Another study confirmed the presence of TB-4 in the early fetal human heart, indicating that TB-4 promotes cardiac cell growth and angiogenesis.

This has staggering implications for synthetic TB-4 analog TB-500. A peptide capable of enhancing cell proliferation and repair in the cardiovascular system could positively transform the field of biogerontology. But is TB-500 safe in the long-term? How can we be sure a therapy that promotes cell growth in the short-term wouldn’t risk disruption of the immune system and carcinogenesis in the long-term?

We need studies that focus on TB-500’s effects on the cardiovascular system – long-term studies that measure changes in gene expression on the cellular level instead of observable phenotype alone. Questions to answer: Can TB-500 improve physical endurance and resilience through cardiac angiogenesis? Are there immunological risks associated with long-term therapeutic use?

Stay tuned next week for our thoughts on MOTs-C, Emideltide, Semax, and Epitalon.

Have thoughts of your own? Comment below!