This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Vertex: More Evidence Cystic Fibrosis Combo Therapy Improves Lung Function

Lung function was assessed by FEV1, which measures the amount of air a patient can forcibly exhale in one second. FEV1 is the measure of clinical benefit accepted by FDA and European regulators for the approval of new cystic fibrosis drugs.

Cystic fibrosis is a progressive disease that causes patients to typically lose about 1-2% of their lung function each year. Yet in Vertex's phase II study, the loss of lung function was accelerated in all patients in the first stage of the study.

From the start of the study through day 28, placebo patients lost almost 1% of their lung function but patients treated with high dose VX-809 alone lost almost 3% of their lung function in the same time period. In other words, VX-809-treated patients were faring worse than placebo.

In the second 28-day stage of the study, the lung function of placebo patients deteriorated by a further 2.5% but patients treated with Kalydeco added to high dose VX-809 rebounded dramatically with an improvement in lung function of 6.1%.

Further evidence supporting the synergistic benefit of combining high dose VX-809 and Kalydeco was seen in the study's responder analysis. In the first 28 days of the study, 10% of cystic fibrosis patients treated with the high dose of VX-809 experienced an improvement in lung function of 5% or more. But when Kalydeco was added to VX-809 in the second 28 days of the study, the percentage of 5% or greater lung function improvers grew to 55%.

Likewise, 5% of high dose VX-809 patients recorded a 10% improvement in lung function during the study's first stage, increasing to 25% when Kalydeco was added to VX-809 in the study's second stage.

Vertex did not disclose responder analyses for patients treated with low- and mid-dose VX-809 plus Kalydeco.

Wall Street expectations for the final results from the phase II study of VX-809 and Kalydeco appear to be largely met, based on a survey of institutional investors recently conducted by ISI Group bio-pharma analyst Mark Schoenebaum.

The 119 investors surveyed, on average, expected to see a 6.7% improvement in placebo-adjusted lung function from the high dose VX-809 arm of the study. This is precisely what Vertex delivered.
2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
VRTX $83.00 -1.59%
AAPL $93.64 -0.11%
FB $118.57 0.84%
GOOG $698.21 0.75%
TSLA $241.80 0.43%


Chart of I:DJI
DOW 17,891.16 +117.52 0.66%
S&P 500 2,081.43 +16.13 0.78%
NASDAQ 4,817.5940 +42.2360 0.88%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs