Próspera, a charter city on Roatán island in Honduras, hosts two biotechs working to combat ageing through gene therapy, as the organisation behind the city advertises its “flexible” regulatory jurisdiction to attract more developers.
In 2021, Minicircle set up a clinical site in Próspera to study the cognitive and health benefits with its circular RNA therapy in a Phase I trial (NCT07216781), in addition to a site in Austin, Texas, where it is headquartered. Last year, the longevity-focused biotech Unlimited Bio got incorporated in the city. Its CEO Ivan Morgunov told Pharmaceutical Technology that Próspera’s lax regulations foster the company’s lofty goal to create a regimen of gene therapies and other treatments aimed at addressing what he sees as the problem of human ageing.
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However, industry experts are not yet convinced. Fellow gene therapy developers question both the scientific plausibility of fighting ageing through combinatorial gene therapies and whether ageing can be pathologised at all. At the same time, it is unknown if such biotechs can gather data acceptable to regulatory agencies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and for such activities to go beyond medical tourism.
Lack of regulatory scrutiny is a key driver
Unlimited is preparing to conduct its first clinical trial in Próspera to study a combined regimen of plasmid gene therapies targeting two proteins; VEGF (vascular endothelial factor), which is involved in forming new blood vessels; and follistatin, an inhibitor of the myostatin gene, which limits muscle growth.
“Próspera is a unique place where we can do such things on healthy individuals,” says Morgunov.
In 2017, Próspera was incorporated as one of three zones for employment and economic development (ZEDEs) in Honduras by the city’s CEO Erick Brimen, a Venezuelan wealth fund manager. The city is now home to more than 300 companies from construction businesses to cryptocurrency startups, enticed by the promise of “a regulatory system designed for entrepreneurs to build better, cheaper, and faster than anywhere else in the world”, according to Próspera’s website.
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By GlobalDataAccording to Thibault Serlet, co-founder of think tank Startup Societies Foundation and former consultant for several charter city projects, charter cities such as Próspera are a relatively new concept, which look to push the business-friendly boundaries of special economic zones (SEZs). Serlet also previously worked as an assistant to Brimen.
Serlet says that at their core, SEZs provide companies with three things: secure property rights, reliable rule of law, and attractive tax structures. For example, the city offers business tax rates as low as 1%. Crucially for biopharma developers, he notes that Próspera offers a more permissive regulatory environment that in major economies such as the US, the EU, and China.
The concept of SEZs is not new. Serlet estimates there are around 5,000 SEZs operating worldwide today, many of which play key roles in supply of the pharmaceutical industry. He points to Costa Rica’s Green Park as an example of an SEZ and pharmaceutical manufacturing hub.
Morgunov plans to make use of this lax environment to market Unlimited’s therapy directly after a Phase I and Phase II study. One component of Unlimited’s investigational combination therapy, the VEGF gene therapy designed to “build new capillaries”, gained approval in Russia to treat lower limb ischemia in 2011. Due to this, Morgunov says Unlimited was able to bring the drug to market in Próspera as a monotherapy within six months of the company’s incorporation.
“If you go to the FDA or EMA, I don’t believe that these agencies would approve [these therapies with] human data from Próspera,” Morgunov states. This is especially true, he says, for preventative therapies that are not aimed at widely recognised diseases as with Unlimited’s gene therapy for ageing. This is key to the charter city’s appeal, says Serlet, as SEZs thrive when companies perceive regulation elsewhere as being too overbearing.
But other gene therapy developers question if agencies such as the FDA impose regulations that are too strict. Miguel Forte, CEO of cell therapy biotech Kiji Therapeutics and president of the International Society for Cell & Gene Therapy, says “it’s a balance”. He says European regulators, for example, need to improve speed and flexibility, but overall agencies are moving in the right direction.
Forte notes a recent paper by the FDA’s director of the Center for Biologics Evaluation and Research Dr Vinay Prasad, which laid out a plan for the FDA to approve rare disease cell therapy platforms that could be used for patients in a bespoke fashion. The policy outlines scenarios where companies could gain approval for personalised therapies, including situations where they could use platform data from similar products for approvals.
Lubor Gaal, CFO of circular RNA developer Circio, agrees that the FDA is making cell and gene therapies (CGTs) easier to develop, accepting smaller-scale studies for rare disease approvals. However, he does not expect regulations to relax significantly soon for broad, non-rare indications.
Like Morgunov, Serlet says there are questions on whether agencies such as the FDA would accept data gathered in Próspera to approve gene therapies. Perhaps more likely than serving as a staging ground for international approvals, Serlet suggests the charter city may act more as a medical tourism destination. One of the most highly publicised individuals associated with Minicircle was the anti-ageing activist Brian Johnson who visited Próspera to purchase treatment from the company. Morgunov also admits that most of Unlimited’s patients come from outside Honduras.
The right way to target ageing remains unknown
Unlimited expects to begin dosing participants in a Phase I/II trial for its VEGF/follistatin regimen in January 2026, administering a two month-long course, with a data readout by April 2026, according to Morgunov. He adds that healthy participants over 45 years old will be enrolled and efficacy will be measured via age-related biomarkers.
The trial will serve as Unlimited’s entry into the semifinals of XPrize Healthspan, a competition driven by a non-profit with a prize of $101m for the winner who can create an innovative therapy to support healthy ageing. The competition has set out the endpoints used to assess efficacy, which include VO₂ max, six-minute walk distance, and leg push weight, along with cognitive and immune function tests. If Unlimited validates its combination approach, Morgunov says the company will build a one-year protocol of gene therapies and other treatments.
Combining gene therapies in this way, “sounds like science fiction,” to Gaal, who says: “A single gene therapy is already very complicated and complex and has a lot of issues.”
Forte says complexity inherently does not rule out combinations outright. He notes that advances in AI modelling may offer a means to analyse and mitigate potentially adverse interactions between gene therapies.
Still, the field remains uncertain on the best way to address ageing.
“Age is not a disease,” states Gaal. Some drug developers have made progress into studying interlinked metabolic disorders, like with glucagon-like peptide-1 receptor agonists (GLP-1RAs), but Gaal says any similar efforts are a long way off from ‘curing’ ageing.
Moreover, ageing is a multifactorial programme rather than a disease with a definable, singular mechanism, says Forte. He warns that there is much to be understood on how ageing can be targeted, and in the meantime there is a risk of ”playing with fire before we know how to control fire”. Contrasting Morgunov’s optimism, Forte advocates for continued research into ageing within well-controlled regulatory environments.
