There are a few questions that seem to come up with almost every extended conversation about Kimer Med and what we're doing. This isn't meant to be an investor disclosure document, or anything like that; it's just an informal discussion of where our thinking is, based on what we know today:
Why now?
- It's been 9 years since Rider's 2011 PLoS ONE paper about DRACO.
- No one else has done anything significant with DRACO since then.
- Rider's MIT/LL patents on DRACO effectively prevented work like this until recently, when they were abandoned.
Why us?
- We strongly believe in the vision and promise of broad-spectrum antiviral technology, and that this work is important.
- We have the entrepreneurial experience needed to run a company.
- We have the scientific background needed to understand Rider's work in depth, and to work with experts to specify and manage in vitro and in vivo testing.
- We have the project management experience needed to select, drive and manage pre-clinical trial testing.
- We see a path from where we are now to a product that could be used in humans, pets and livestock.
Why “VTose”? Why don’t you just keep calling it “DRACO”?
- As defined by Rider, "DRACO" is actually his name for a family of compounds, not just one.
- DRACO is Rider's thing, done a certain way. We will certainly end up doing some or perhaps many things differently, and don't want to claim to be something we're not.
- We want our own trade name for a single compound that will also reflect our investigations, effort and innovations.
How long will it take to bring VTose to market?
- There are hundreds of moving parts that feed into an answer: everything from which viruses we end up testing against to which tests we run, which labs we use, what our results look like, and so on. Plus funding, of course!
- If we end up with enough funding, our preference would be to focus on Clinical Trials first and foremost.
- With less-than-optimal funding, we are planning to work with veterinary specialists in New Zealand, and other vets internationally, to treat one or more viral diseases in pets and/or livestock. This will allow us to bring a product to market sooner than would otherwise be possible, but might also slightly delay a product for humans.
- The average time to bring a new drug to the end of Phase 3 trials and to a New Drug Application in the US is roughly 6 to 7 years. We believe we can do better.
How long until Phase 1 clinical trials?
- This is basically the "near term" version of the question above, so the same issues apply.
- With enough funding, a relatively narrow focus, and no significant distractions, we believe it's possible to complete pre-clinical trial testing and analysis and an Investigational New Drug (IND) application in 18 to 24 months.
- Having said that, we don't know what we don't know. Surprises and roadblocks are possible.
How much will it cost?
- Very similar story to schedule: lots of moving parts, many of which are the same as the ones that affect schedule.
- Even the pace of funding affects total cost. A slower pace will both take longer and cost more.
- We believe there's lots of room for cost (and schedule) improvements and optimizations compared to the conventional Contract Research Organization (CRO) path that's often used for pharmaceutical development.
- One of the reasons we chose New Zealand for the company's headquarters is that the regulatory environment is such that it will help with both cost and schedule.
- The average cost to bring a new drug from Phase 1 through Phase 3 trials in the US is about $37M. We believe we can do better.
How much do you need in the short term?
- It would take about $1M to fund a narrow but decently paced pre-clinical trial program over the next year.
- However, we could also put a lot more than that to good use.
- Budget and schedule numbers like these always come with lots of caveats.
- One of the many things affected by funding is which viruses we end up targeting. We know DRACO was effective against 15 different viruses. Based on the way it works, we believe VTose will be effective against even more. The breadth of our testing will be directly determined by funding.