CARA
The management of this company is a good example of why you cannot invest in a company just because they have a reasonably good drug (the IV version of the drug is actually approved for pruritis (in T2D), and several of the ph2s of the oral version in other indications have stat sig in primary endpoint). They have an extensive history of poor decisions.
The best ph2 was in Notalgia Paresthetica - hit strong stat sig in primary endpoint of itch reductions, altho secondaries, like sleep disturbance, were mininal efficacy, albeit likely for other reasons. Note that this was at a higher dose than in Atopic Dermatitis.
In the Atopic Dermatitis they did not hit stat sig at any dose and carried forward an intermediate dose, even though a higher dose got a substantially better result and side effects are not huge (constipation, excess urination in Notalgia Parathetica, which used higher dose).
They were pretty clear that their goal was biggest possible indication - hence ignoring the indication with much stronger ph2 results. (At least one of the conf calls was pretty interesting because the analysts were clearly probing with the message 'what in the world are you doing?')
I'll have to now re-assess for any on-going trials (they should have a ph3 on-going in non-dialysis dependent CKD - and their ph2 was partial success (met endpoint, but not for responder version FDA would want in ph3), since I've been ignoring it until the bad trials run their course.
BTW - amusingly they are the only biotech I've seen put out a PR on ESG Report.
