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NNVC-USAMRIID EbolaCide Test - How Risky? —GP,

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leifsmith   Thursday, 12/18/14 07:55:25 PM
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Post # of 145447 
NNVC-USAMRIID EbolaCide Test - How Risky? —GP, author of this post is a co-founder & director of a biotech startup

EbolaCide is almost a zero risk proposition for NNVC. It’s got upside, and extremely limited downside: the opportunity cost is limited to the single digit number of weeks that working on it did anything to delay FluCide or MersCide coming to market. You could make an argument about revenue-foregone in the area under the curve, but that’s about it. You could also query whether critical corporate resources are being expended on EbolaCide which will prevent FluCide continuing. If the answer is “no,” it’s hard to see how this is high risk.

The reasons why EbolaCide is so low risk include:

1. The company is buffered by its pipeline. For any pharma (so this is the case with NNVC) with multiple drugs NEAR THE FRONT OF THE PIPELINE, and the RESOURCES TO BRING THOSE DRUGS THROUGH TESTING, if there were complete and total failure of any single drug it would not be a death knell. Disappointing, yes. Impact short term stock price, yes. Corporate doom, no. Bring out the next drug.

If you were to bet which of the two drugs - FluCide or EbolaCide - would most likely succeed, FluCide is the logical choice. FluCide is the drug that was worked on most carefully, and it's the one that is officially proceeding through formal tox. EbolaCide was brought out of mothballs in response to the crisis. It’s a rush job. Although knowledge about Ebola has grown in the last few years, the virus is complex and the general data on it is significantly less than for influenzas. Because of the lethality of Ebola, NNVC cannot do the robust exploration and testing that they were no doubt able to do with flu viruses.   Frankly, one would expect a better showing coming out of FluCide than out of Ebolacide II.

The highest risk factor is always Unknown Unknowns (called “unk unks” in aerospace). This is not like solving for X. An Unknown Unknown is something you don’t even know exists – it’s Q. It was an Unknown Unknown that led to impaired performance of the original EbolaCide compound. Could there be another Unknown Unknown that impacts Ebola II? Sure. Then it’s back to the lab to engineer another variant. It is only logical to expect a better showing coming out of FluCide than out of Ebolacide II. NNVC is going to do a lot of learning with Ebolacide II. If Ebolacide II is 99% effective, it’s possible that it won’t be reworked. But given what they will learn, an Ebolacide III would be even better.

2. Efficacy compared to competition. What is the alternative to EbolaCide? (Let's say we're playing by formal FDA rules, instead of being in an emergency situation in Africa.) If EbolaCide can show a statistical improvement over the established Ebola treatment, e.g., 1%, then FDA will approve it as a drug. And what is the name of the established Ebola treatment? Right now, there is nothing.

If EbolaCide cut the death rate by half in countries where no one gets intensive supportive care, this would be a big humanitarian win for lives saved and a big win for the company. If a 50%-effective EbolaCide could be produced in big enough quantities that a whole village or neighborhood could be treated even before people were symptomatic, this would go a long way to stamping out the epidemic.

Even established vaccines like measles don’t run 100% effective. Cubicin doesn’t win every time. If EbolaCide II shows any efficacy, NNVC has a first drug to market. The cides would have shown they do no harm in humans, and provide benefit even with a version that was whipped up quickly. If EbolaCide II delivers a 30-50% survival rate, then resources allowing, it will show up in a cocktail with other treatments, just like people putting together AIDs cocktails. EbolaCide II will have to share credit with the rest of the cocktail, just like right now intensive supportive care is part of the treatment mix in the US for Ebola and all other hemorrhagic fevers. Then NNVC can go back to the lab and do even better with EbolaCide III.

Worst Case scenarios:

1. Somebody else shows up with a vaccine or effective treatment before EbolaCide gets out there. Disappointing.

2. The only potential downside would be the nightmare scenario in which even though they did animal testing, a new drug takes an 80-90% mortality rate to 100%. Odds of this happening given what we know about tox are super low.

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