Disease atlas
Where the diseases we work on actually occur. Nineteen points across eleven pathogen groups, plus our own two sites.
This map shows disease burden, not clinical activity. Every one of our twenty-seven trial sites is in the United States, because all twelve studies are first-in-human studies in healthy adult volunteers. The gap between where a disease is and where its medicine is being tested is one of the central awkwardnesses of this field, and it is discussed further down this page rather than left implied.
Why the medicines are tested thousands of miles from the diseases
A Phase 1 study asks two questions: is a dose tolerated, and what does the body do to the drug. Neither question requires a participant to have the disease, and for most of these diseases it would be indefensible to wait for one. Marburg virus disease kills a large majority of those it infects within about a fortnight. There is no window in which a first-in-human safety study could ethically or practically be run at the bedside of a person with it.
So the safety and pharmacokinetic work happens in healthy volunteers in the United States, and the evidence that a medicine actually works has to come from somewhere else. For most of these programmes that somewhere else is the FDA Animal Rule, 21 CFR 314 Subpart I, which permits efficacy to be established in well-characterised animal models when a human efficacy trial is neither ethical nor feasible. It is a demanding standard and it is not a shortcut. It requires the animal model to be understood well enough to predict the human response, which is a much harder thing to demonstrate than it sounds.
Three programmes are exceptions. Hantavirus cardiopulmonary syndrome, melioidosis and the mpox indication of BX-1140 all produce enough annual cases that a randomised controlled trial can realistically be enrolled, so those will go the conventional 505(b)(1) route. Where a randomised trial is possible we will run one, because it is better evidence.
None of this resolves the underlying problem, which is that the people who would benefit most from these medicines live in places that have the least influence over whether they get made. We do not have a satisfying answer to that. The partnering and preparedness page describes the funding mechanisms that partly compensate for it, and they only partly do.
What is on the map
| Group | Disease | Where | Candidate |
|---|---|---|---|
| Henipavirus | Nipah virus infection | Bangladesh, eastern India, Kerala | BX-101 Nipavir |
| Filovirus | Marburg virus disease | Equatorial Africa | BX-204 Marburavir |
| Filovirus | Sudan ebolavirus disease | Uganda, South Sudan | BX-806 Sudanavir |
| Bunyavirus | Crimean–Congo haemorrhagic fever | Turkey, the Balkans, the Caucasus, Central Asia | BX-412 Cehafex |
| Arenavirus | Lassa fever | Nigeria and the West African Lassa belt | BX-515 Lassivar |
| Arenavirus | South American haemorrhagic fevers | Argentina, Bolivia, Venezuela, Brazil | BX-1265 Arenavir |
| Lyssavirus | Symptomatic rabies encephalomyelitis | Worldwide; the largest burden in South Asia | BX-620 Rabivex |
| Hantavirus | Hantavirus cardiopulmonary syndrome | Andean South America; the American south-west | BX-733 Hantrelvir |
| Orthopoxvirus | Clade I mpox | The Congo Basin | BX-1140 Poxavir |
| Phlebovirus | Severe Rift Valley fever | East Africa, the Arabian Peninsula | BX-1330 Riftavir |
| Prion | Sporadic and genetic Creutzfeldt–Jakob disease | Worldwide, roughly one to two cases per million per year | BX-308 Prionex |
| Bacterial | Melioidosis | North-east Thailand, northern Australia, South Asia | BX-1620 Meliovex |
Creutzfeldt–Jakob disease has no geographic reservoir and the point placed for it in central Europe is arbitrary. It is on the map only so that the programme is not silently absent.
What it does not show
Absence of a point does not mean absence of risk. Several of these pathogens have reservoir ranges considerably wider than their recorded human case distribution, and recorded case distribution is itself a function of how hard anybody has looked. The Crimean–Congo haemorrhagic fever range in particular is expanding with the range of the Hyalomma tick, and the map here is a snapshot of a moving boundary.
The outlines are drawn coarsely on purpose. This is an orientation device, not a survey, and a reader who needs precise geographic epidemiology should go to the primary sources rather than to a diagram on a company website.
Ten therapeutic areas, twelve candidates, twelve studies
The therapeutic areas page describes each disease and why it was chosen. The study finder lists every trial, its design and its recruitment status.