A Shabby Pop-Sci Article on the Minicircle Trial of Follistatin Gene Therapy

Minicircle is working towards the upregulation of follistatin, an inhibitor of myostatin and thus an interesting target for improved muscle growth and treatment of sarcopenia. Follistatin and myostatin are well studied genes in this context, and there are any number of animal studies, as well as human trials of various approaches to myostatin inhibition. As I have long said, follistatin and myostatin are probably the most compelling, least risky genes to start working on if interested in gene therapy development. There is a great deal of animal and human data to support this work.

It is always annoying to see shabbily written popular science articles in which ignorance is brandished with a sort of pride. The author of today's article couldn't get Minicircle to comment on the details of their work, has no real idea as to what is going on under the hood, and so forges ahead with a mix of snark and commentary from various people who also don't know what Minicircle is doing, or the nature of their gene therapy approach.

I am a participant in the Minicircle follistatin trial. I've also signed a non-disclosure agreement, so don't ask me for details. The company has an interesting, novel technology for the delivery of gene therapies, and is undertaking a responsible, low-cost, first-in-human clinical trial outside the US with educated volunteer participants from the self-experimentation community. It consistently amazes me, the degree to which hostility is poured upon those who choose not to engage with the journalistic and regulatory priesthoods in exactly the approved fashion.

The present system of regulation, and the enormous costs it imposes on development and discovery, must change. We live in an era in which a prototype gene therapy can be safely assembled for a few thousand dollars in cost of goods. It cannot continue to be the case that development only progresses at a cost of tens of millions of dollars to reach initial human trials, and hundreds of millions to billions of dollars to allow the average person to be permitted to use a treatment.

This biohacking company is using a crypto city to test controversial gene therapies

Over the past few years, a parade of newly released gene therapies have consecutively claimed the title of most expensive drug in the world; the current honor goes to the $3.5 million hemophilia B treatment Hemgenix, launched in November 2022. Minicircle is taking something of a different tack. The startup, which is registered in Delaware, aims to fuse elements of the traditional drug testing path with the ethos of "biohackers" - medical mavericks who proudly dabble in self-experimentation and have long hailed the promise of DIY gene therapies

The eccentricities don't end there. Minicircle's trials are going ahead in Próspera, an aspiring libertarian paradise born from controversial legislation that has allowed international businesses to carve off bits of Honduras and establish their own micronations. It's a radical experiment that is allowing a private company to take on the role of the state. While much attention has been paid to the charter city's use of Bitcoin as legal tender, the partnership with Minicircle is an important milestone toward another goal - becoming a hotbed of medical innovation and a future hub of medical tourism.

It's against this unusual backdrop that Minicircle is trying to lead biohacking's charge into the mainstream, or at least somewhere near it-studying gene therapies that target familiar conditions like muscular disorders, HIV, low testosterone, and obesity, and doing so with the backing of tech moguls and under the purview of bespoke "innovation-friendly" regulation. It ultimately aims to democratize access to gene therapies, with an emphasis on discovering the right nucleic cocktail to promote longevity. 

Most scientists I spoke with are less than enthusiastic about Minicircle's undertaking, expressing skepticism about its methods and aims, while experts in medical ethics are concerned about how the trials will move forward - and what they could mean for the burgeoning and sometimes unscrupulous medical tourism industry.  These experts also say the red-tape-trimming stance of special economic zones like Próspera can set off alarm bells (though the charter city staunchly defends its regulations).

At least one prominent scientist sees a potential upside to growth in the biohacking space: George Church, a professor of genetics at Harvard Medical School who has previously consulted on biohacking endeavors, tells me he welcomes the evolution of biohacking self-experimentation into full-blown clinical trials. He isn't familiar with Minicircle's work specifically, but he says of the general premise, "As long as nothing goes wrong, it could herald a revolution in cost reduction." That, of course, is a big caveat.