Placebo responders in three Amtiza trials were: 18.9%, 15.4%, 13%
We can only wonder how the Linzess trials were rigged to produce placebo responders percentages that were so low.
Oops I realized I copied the data for the Amtiza IBS trial. The percent of placebo responders in the CIC trial was even higher.
Edited from the DailyMed NIH website:
14.2 Opioid-induced Constipation
The efficacy of Amitiza in the treatment of opioid-induced constipation in patients receiving opioid therapy for chronic, non-cancer-related pain was assessed in three randomized, double-blinded, placebo-controlled studies.
The proportion of patients in Study 1 qualifying as an “overall responder” was 27.1% in the group receiving Amitiza 24 mcg twice daily compared to 18.9% of patients receiving placebo twice daily (treatment difference = 8.2%; p-value = 0.03).
The proportion of patients in Study 2 qualifying as an “overall responder,” as prespecified in Study 1, was 24.3% in the group receiving Amitiza compared to 15.4% of patients receiving placebo.
The proportion of patients in Study 3 qualifying as an “overall responder,” as prespecified in Study 1, was 15.3% in the patients receiving Amitiza compared to 13.0% of patients receiving placebo.
Then why was the percent of placebo responders in Amtiza trials closer to that in the plecanatide trial?
Amtiza placebo responder rate was 10.1%. The placebo responder rate in the Linzess trial was too low. Something smells rotten.
An analysis of two phase III, randomized trials comparing lubiprostone 8 µg twice daily versus placebo for 12 weeks included 1,171 patients who met Rome II criteria for IBS-C. Study subjects recorded their symptoms in an electronic diary. The primary endpoint for this study was the percentage of subjects whose symptoms were at least moderately relieved for all 4 weeks in a month, or significantly relieved for 2 weeks in a month. A patient was considered an ‘overall responder’ if they were monthly responders for at least 2 of the 3 months. The lubiprostone arm had a significantly greater percentage of overall responders compared with placebo (17.9% versus 10.1%, p = 0.001).
Could it be that subjects in the Linzess trial were aware they were receiving placebo, therefore eliminating the "placebo effect" that is typically a factor? Is that why the percent of placebo responders were atypically so low in the Linzess trial?
There are ways to structure a trial to limit the placebo effect. Unless you dissect each trial in detail, you cannot make the blind comparison you're postulating.
Ted Radio Hour for July 31 web cast is entitled Fighting Cancer. A speaker comments on the importance of systems biology and targeted therapy in the treatment of cancer.
I owned Trius Therapeutics when it was bought by Cubist after phase III, but before FDA approval. This is from the write-up on FierceBiotech.
Cubist splurges on Trius and Optimer buyouts to spur antibiotics growth
July 30, 2013 | By Ryan McBride
Cubist has agreed to scoop up San Diego-based Trius for $13.50 per share in cash or $707 million and a contingent value right for each share worth up to $2 based on commercial milestones, making the deal worth a total of $818 million. The buyout deal, which the boards of both companies have approved, features Trius's experimental antibiotic tedizolid phosphate. The antibiotic candidate has succeeded in a slate of late-stage studies, and regulatory filings for approval are expected in the second half of 2013.
Boehringer Ingelheim has agreed to hand over as much as $730 million to South Korean drugmaker Hanmi Pharmaceutical in exchange for the rights to a midstage treatment for lung cancer, betting the drug can stand out in a crowded field.
Under the deal, Boehringer is paying $50 million up front to partner up on Hanmi's HM61713, promising up to $680 million more if the drug clears certain clinical and commercial milestones.
The oral treatment is a kinase inhibitor that targets EGFR, a receptor that plays a role in cell growth and, when mutated, can lead to cancer. EGFR is a well-worn path in oncology, a target shared by Roche's ($RHHBY) Tarceva and Boehringer's own Gilotrif, among many others.
Endo International (NASDAQ:ENDP) prices its public offering of 24,024,025 ordinary shares at $83.25 per share. Underwriters over-allotment is an additional 3,603,603 shares. Closing date is June 10. Net proceeds will help fund its Par Pharmaceuticals acquisition.
I would be REALLY excited if NTEC had a once daily pill formulation. Unfortunately the phase III trial uses twice daily and three times daily doses.
Anyone else looking at NTEC? They are doing an IPO Monday. They have what looks like a relatively safe bet on a formulation of levodopa for better GI uptake - ready for phase III. For comparison, look at NDRM. NDRM has done very well this year. They are working on a subcutaneous levodopa pump, also ready for phase III. However, all of the NDRM indications are for patients failing on oral levodopa, so it would appear than NTEC might be worth a look???
It's trading like a stock now, following oil up and down. Seems the time to buy would be when oil bottoms... if you're smart enough to be able to pick the bottom. I've read lender pain starts sometime next year when defaults start to mount up if oil price stays below production cost.
From the recent press release:
Synergy plans to announce top-line data results from the second phase 3 CIC trial with plecanatide in the first half of 3Q 2015. The company plans to file its first new drug application (NDA) with plecanatide in the CIC indication in the fourth quarter of this year.
Big, you should want MACK to break about the 200day. It's a gift. Regardless what happens now, the price will be the same when the FDA approval arrives.
I'm seeing a perfect storm. The support trend line, the 200day ma and the last major resistance point are almost all lined up together. It looks like that number is around 10.75. Once it breaks that, there's no support until it reaches the high 8's. This is a gift that longs have been waiting for. Unlike Jan, we know why the price is falling this time and it has little bearing on the outlook for MACK... so it's a free pass to buy... agree?
Hard to believe Ironwood would have rejected this offer. Is this even in the realm of possibilities for SGYP:
LONDON (Alliance News) - Shares in Ironwood Pharmaceuticals Inc were trading higher in the US on Thursday after rumours the company has become an acquisition target and has been approached by European suitors, including Shire PLC, the Daily Mail reports.
The paper said Ironwood has rejected cash offers thought to be in the region of USD30 per share, which would value the company at around USD3.7 billion.
In the July issue of Master Investor magazine, Jim Mellon sees SGYP as a buyout candidate that wants to be bought. He has met with the management previously and has been recommending SGYP for months.