Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced the completion of enrollment in two phase III studies evaluating its next-generation corrector, VX-659, in combination with tezacaftor and Kalydeco (ivacaftor) for treating cystic fibrosis ("CF"). While one study is evaluating the triple combination regimen in patients with one F508del mutation and one minimal function mutation, the other study is in patients with two F508del mutations.
Top-line data from these studies are expected in the fourth quarter of 2018. Apart from VX-659, Vertex is also evaluating another next-generation corrector, VX-445, in combination with tezacaftor and Kalydeco in two more phase III studies in CF patients with similar mutations like VX-659. The studies are currently enrolling patients and the process is expected to be completed in the fourth quarter of this year. The company expects to announce top-line data on VX-445 in the first quarter of 2019.
The company has plans to compare the efficacy of both the triple combination regimens and will select the best regimen based on the interim analysis of these studies. Interim analysis will evaluate the primary endpoint of ppFEV1, a measure of lung function, at four weeks and safety of the regimens over 12 weeks.
A new drug application for the best regimen is expected to be submitted by mid-2019 for CF patients with one F508del mutation and one minimal function mutation.
So far this year, Vertex’s shares have gained 20.1% against the industry’s decline of 4.9%.
Vertex has three drugs in its CF portfolio, Kalydeco, Orkambi and Symdeko. Symdeko was launched in February and has allowed the company to address a significantly larger CF patient population in the United States. The drug has shown strong uptake since its launch.
Kalydeco sales grew by almost a third in the first six months of 2018 compared with the year- ago period. However, Orkambi has witnessed modest growth as it faces few obstacles in some European countries related to reimbursement agreements. Total product sales from these three drugs were $1.4 billion in the first half. The company expects full-year sales to be in the range of $2.9 to $3 billion.
The successful development of either of these two triple combination regimens is expected to be favorable for the company’s growth going forward. Both these triple combination regimens are of significant importance to the company’s progress in CF segment as they are capable to treat almost 90% of CF patients. This will significantly increase the eligible patient population for Vertex’s CF drugs, thereby boosting top-line growth for Vertex, if successful.
We remind investors that Galapagos NV (GLPG - Free Report) and its partner AbbVie (ABBV - Free Report) announced disappointing data from the phase II study of their CF candidate, GLPG2737, in June. GLPG2737 in combination with Orkambi had lower improvement as measured by ppFEV1 compared to VX-659 and VX-445 triple combinations. This had a favorable impact on Vertex as GLPG2737 gives the company a clear leadership in the development of CF treatments.
Meanwhile, Corbus Pharmaceuticals Holdings, Inc. (CRBP - Free Report) is also developing a CF candidate, lenabasum, in a mid-stage study.
Vertex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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