Macro Tsimmis

intelligently hedged investment

Vertex (VRTX) update #5

Posted by intelledgement on Wed, 09 Jan 08

We were actually hoping to be writing this update last month, and focusing on the details for Phase 3 trials of Vertex’s (VRTX) protease inhibitor telaprevir, but obviously it is taking the company longer than expected to iron out the details with the FDA. Management did issue a press release this morning, however…actually, now yesterday morning…and here is a summary of their 2008 outlook.

The main focus remains Phase 3 for telaprevir. Management have submitted a Phase 3 trial design to the FDA, and anticipate discussing it with FDA officials later this month. The design includes 8- and 12-week regimens of telaprevir dosing as part of a 24-week treatment with all patients getting interferon and ribavirin for the full 24 weeks, plus a control arm of patients who get SOC treatment (interferon and ribavirin) for 48 weeks. They promise an update by 11 February. In the meantime, Vertex’s ROW partner, Tibotec (a subsidiary of Johnson & Johnson/JNJ), are developing a design for Phase 3 trials in Europe.

Also in the cards for 2008 is progress on VX-500, the company’s “next generation” HCV protease inhibitor. Vertex has initiated dosing in a Phase 1a clinical trial evaluating single, escalating doses of VX-500 in healthy volunteers. Pending results from the Phase 1a trial, management expect to initiate in mid-2008 a Phase 1b trial of VX-500 in HCV patients.

Additionally, another next-generation investigational HCV protease inhibitor is expected to advance from research and enter clinical development in 2008.

Also on the radar screen are a couple of cystic fibrosis (CF) candidate drugs. Vertex is conducting a randomized, double-blind, placebo-controlled Phase 2a trial of VX-770, an investigational potentiator compound for the treatment of CF. In the trial, VX-770 is being dosed as an oral therapy in patients with CF. Pending results from the Phase 2a trial, Vertex plans to advance VX-770 into a larger Phase 2b trial.

The company has also initiated dosing in a Phase 1a trial for VX-809, an investigational corrector compound for the treatment of CF. The trial will evaluate single and multiple doses of VX-809 in healthy volunteers. Pending results from the Phase 1a trial, Vertex expects to initiate a subsequent Phase 1b trial in patients with CF in mid-2008.

Bottom line, we are growing increasingly concerned about the delay in the Phase 3 telaprevir trial. This announcement is a notable comedown from management’s previous optimism that the Phase 3 trial would start—or at least be announced—by the end of 2007. If the delay in the start of the trial is substantial, having the results available in time to gain an FDA decision on approval by 2010 is going to be problematic. This bears close watching.


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