Needham analyst reaffirms buy rating and price target on Vertex this morning
Needham & Company analyst Alan Carr weighed in on Vertex (NASDAQ: VRTX) following top-line results from a Phase 2 trial of ivacaftor in cystic fibrosis patients with residual function CFTR mutations.
"We note statistically significant, but modest absolute changes in FEV1 in the two-part trial (2.8% vs. 0.6% placebo [p=0.004] in 2-wk blinded Part 1 and 4.7% [p=0.0001] in 8-wk open-label Part 2)," Carr said. "Based on these results, the company plans to move forward with a Phase 3 trial after discussions with regulators around trial design. Results from the pivotal TRAFFIC and TRANSPORT trials are expected soon. These trials are testing ivacaftor/lumacaftor in homozygous F508del pts and are at the core of the company's CF strategy. We continue to expect a positive outcome and reiterate our BUY rating and $95 target."
Why is the FEV1 effect so small? Perhaps the short duration of the study or perhaps because the residual channels and not potentiated as much with ivacaftor? Still, it is amazing that with less than 3% improvement in FEV1 they got a p=0.0001.
Clearly ivacaftor works as a drug, the question is if lumacaftor does indeed work. We will know soon, I guess.
I fear that they released this data on a small phase II study ahead of the phase III data to provide some good news prior to "disappointing news" ... I hope to be wrong.