If patients from the 30mcg and 75mcg dose cohorts of the SAD trial are happy to roll over into the open label extension trial it will mean data can be collected for 6 patients receiving multiple doses of 30mcg and a further 6 patients receiving multiple doses of 75mcg. So potentially, double the repeat dose patient data.
The other thing that’s exciting, if my understanding is correct, is that we could now see second dose 75mcg administered as early as within the next few weeks. The 75mcg dose SAD cohort had all received their dose by mid-May. If the second dose is to be administered as close as possible to 12 weeks after the SAD trial dose (as stated in this announcement), that means the 75mcg SAD group should receive their second dose by early August.
As things stood, the 75 mcg MAD cohort couldn’t commence dosing until after the 4 week safety review following the second dosing of the 35mcg cohort (dosing is at 8 week intervals). So second dosing at 75mcg in the MAD trial had been many months away.
It’s in this repeat high dose group that any adverse events and clearer signs of efficacy are likely to be seen, imo.
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