Pfizer says pivotal trial for Clostridioides difficile shot did not meet main goal

Jeenah Moon/Getty Images News

Pfizer (NYSE:PFE) is trading lower in the pre-market Tuesday after the company announced that its pivotal Phase 3 study for Clostridioides difficile vaccine candidate (PF-06425090) did not meet the primary endpoint in the prevention of the infection.

However, in terms of secondary endpoints, the experimental vaccine has demonstrated its potential in reducing the duration and severity of the disease, Pfizer (PFE) said, adding that the company is currently evaluating the next steps of the program.

The vaccine was found to be well tolerated with a favorable safety profile in the CLOVER trial that involved nearly 17,500 adults aged 50 years and older.

The subjects received three doses of the C. difficile vaccine (n=8,766) or placebo (n=8,769) at 0, 1, and 6 months.

In terms of people who sought medical attention for CDI, the case split between the vaccine and placebo stood at 0-11, indicating 100% vaccine efficacy.

The median and mean CDI duration for vaccine and placebo reached 1 versus 4 days and 3 versus 16 days, implying a 75% and 80% reduction in disease episode, respectively in vaccinated people.

“We are encouraged by the promising potential benefit observed against more severe C. difficile infection, as a large portion of cases lead to extended diarrhea episodes that can require hospitalization,” noted Kathrin Jansen, Senior Vice President and Head of Vaccine Research & Development of Pfizer (PFE).

Clostridioides difficile infection is a potentially fatal condition linked to diarrhea.

Read: In December, a Phase 3 trial run by Summit Therapeutics (NASDAQ:SMMT) for an experimental medicine for CDI failed to meet the primary endpoint.

Comments

[cntrofatttn]

The comments and news regarding the covid vaccine shots for 5-11 yos are not that significant for PFE as loads of countries are already buying their new covid pill Paxlovid. Germany alone has bought 1.000.000 packages for this year. I guess this medication will be their bestseller for 2022 and if some other medications make the trial phases and enter the market... even better. For the patients and PFE. I have a serious condition myself and I'm always pretty thankful if there comes new (perhaps better) medication on the market that can help me and other patients. If it doesn't it was at least a try. Every body reacts different. Just my humble opinion. Stay healthy everyone!

[Meghan Griffith]

I live with a hard to tolerate disease called chrones disease. It will kill a person that doesn't have the mental capacity to adapt. A person will die from eating and not changing their habits. Self pity is going to kill a person faster. Chrones, is not genetic, I believe it to be a systematic byproduct of poison in our foods and the uncleanliness of others. Also, surviving very bad injuries to spine and neck areas has been something that western and eastern medicine has discovered well before modern hospitalization.

I study vedic medicine. A lot of what I deal with needs organic herbs, spices, less preservatives in my food, no wheat or dairy products can touch any of my food because wheat and diary grow harmful bacteria in my stomach and then my pancreas and gallbladder won't break it down. The symptoms are similar to cancer but it's survivable. If you don't change the disease kills you faster.

I deal with lose of appetite, my mind has to be told to decide and eat to survive most days. Because, I have to prepare the food I eat most days, but there are plenty of ready to eat options, like fruit, and veg, and potatoes or sushi. I grow marijuana as well, really good marijuana. And I'm working on making the strains the most organic they can be, all grown with homemade soils, fertilizer, ect. Marijuana helps a person like me make upy mind, I spend less time being distracted by my loss of appetite. Also, a decent iron added vitamin helps. And Maybe hit the gym, the workout will help your mind feel better. Gets anger out, frustration and anger are lessened by a nice workout.

[biogenius]

The vaccine is potentially approvable if the indication is for Covid.

[anyguy]

@biogenius Yes, but will a booster shot be available?

[VoiceofSanitySometimes]

@biogenius

Bad news from Pfizer on the covid front. Shots for 5-11 yos are a bust (12% efficacy, which may not even be statistically significant given the sample size), and the efficacy for 12-15 yos is dropping like a rock. Not surprising if you understand how these shots work...

[biogenius]

@anyguy
That is funny. One shot of the vaccine for CDI has the same efficacy as 3 shots of Covid vaccine for Omicron.