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Saturday, 04/02/2016 12:00:11 PM

Saturday, April 02, 2016 12:00:11 PM

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GNCA responds to Adam Feuerstein tweets

Thanks for your email. It’s important to understand the design of the trial and the totality of the data which we have announced since last May rather than to react to a tweet without context.

We enrolled 310 patients with a history of recurrent genital herpes into one of 7 dose groups, six active arms and placebo. The placebo patients were only followed for the first 28 days after completion of dosing as a comparator for safety and tolerability as originally specified in the trial protocol.

The primary endpoint of the trial was to evaluate the impact of these doses on viral shedding as measured by the change from baseline. Viral shedding is the most objective and efficient approach to demonstrate the anti-viral activity of GEN-003, particularly in a smaller trial, and is therefore a perfect endpoint to study for the purposes of efficiently identifying the best dose for late stage trials. Viral shedding rates were measured over four 28 day observation periods— first before dosing, to establish each subject’s baseline shedding rate, then immediately after the third dose, again at 6 months and finally at 12 months post dosing.

If you look at slide 7 of yesterday’s presentation, you will see the statistically significant and sustained reduction in viral shedding which we observed in this trial, including the placebo arm through 28 days, which does not change, as you would expect.

This clinical trial also included a number of secondary endpoints in order to explore the potential effect of GEN-003 on clinical disease.
These included the proportion of patients who were recurrence free at 6 and 12 months after the last dose, and the time from the last dose of GEN-003 to the next lesion outbreak. Reporting for these endpoints required the clinical trial site to confirm the genital lesion visually and by PCR test for HSV-2 DNA. We also collected data on the percentage of days that patients reported the presence of herpes genital lesions during the same observation periods we used for viral shedding

For these exploratory clinical endpoints, we do not have the benefit of a placebo arm at 6 or 12 months, but we believe we are seeing a sustained impact on clinical disease by these measures which is similar to the results using those endpoints from the Phase 3 trials for antiviral therapies (where we can also look at historic placebo rates). Of note is that the % lesion free data you see on Slide 8 is a likely Phase 3 endpoint for us.

As we announced in May last year at the post dose 3 time point, we saw an unexpected placebo response in the patient reported endpoint of genital lesion rate. We believe this was due to the fact that the trial was highly anticipated given the activity we had shown in our Phase 1/2a trial and that the randomization ratio of 6 active to 1 placebo may have contributed to patients underreporting their lesion events given an assumption they were on active drug. Whilst we do not have the benefit of placebo at 6 or 12 months, the fact that the active arms show such a consistent, sustained and statistically significant reduction in genital lesions through this trial gives us confidence that the effect we are seeing is real.

As we said on the call yesterday, this data improves GEN-003’s already-strong commercial profile and we are looking forward to reporting data from our ongoing Phase 2b trial later this year.

Kind regards


Sent: Thursday, March 31, 2016 6:37 PM
To: Jonathan Poole <>
Subject: The Street Bio analyst blast recent gen 3 data

He said since there was no 12 month placebo group that the data is junk. His tweet caused stock to tank in after hours.

User Actions
Adam FeuersteinVerified account?@adamfeuerstein
. @IraBidermanDDS The GEN-003 vs placebo lesion reduction data disclosed by $GNCA today (slides 9 & 10) look terrible. No difference.