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Clinical trial failure is one of the harshest realities in pharmaceutical R&D, which can "waste" a company's funds and may affect the development of pipelines in other indications, but most importantly, patients feel "cornered"
.
Typically, drug failure has the greatest impact in late clinical stages and near the end of the
trial.
Although the new drug has been relatively stable in the later stage, there is no guarantee that it can absolutely pass the
clinical trial and be marketed safely.
A review of 640 trials published by Contemporary Clinical trials Communications found that 54 percent of new therapies failed in phase III trials, 57 percent of them because of insufficient
efficacy.
Over the past few months, disappointing trial data has covered products from early to late development and targeted a range of different diseases
.
Here are five of the most impactful trial failures
.
1 AstraZeneca/Oxford COVID-19 nasal spray vaccine failed
1 AstraZeneca/Oxford COVID-19 nasal spray vaccine failed Drug developers have been actively looking for a next-generation COVID-19 vaccine to overcome some of the vaccine's limitations, and nasal sprays certainly offer new ideas
.
Nasal sprays not only allow the immune system to attack viruses where they enter the body, but they are also easier
to use.
At least 12 nasal spray COVID-19 vaccines are in development, with four vaccine candidates in Phase III trials
.
Several studies reported positive results, two of which received regulatory approval: one in China and the other in India
.
But this month, AstraZeneca and the University of Oxford said that nasal sprays for their ChAdOx1 adenovirus vector vaccine "failed to induce a consistent mucosal antibody response or a strong systemic response"
in a small phase I trial.
According to the researchers, the study is believed to be the first publication of data on adenovirus vector vaccines using "simple nasal sprays," which are easier to use
than Chinese-approved sprays that require complex spraying devices.
Previously, 24 countries reported that the vaccine was linked to rare blood clots, which led to a suspension of its use
.
Still, AstraZeneca made $4 billion on COVID-related products last year, but the company expects its sales to fall by at least 20 percent
in 2022.
AstraZeneca's hopes to revive its market position with a nasal spray vaccine are slim
.
Of course, work is underway
in the industry to develop nasal sprays using other technologies.
New York-based Codagenix says its COVI-VAC nasal spray vaccine could be approved
as early as next year.
2 Biohaven's Phase II trial of ALS drug failed
2 Biohaven's Phase II trial of ALS drug failed On September 29, Amylyx Pharmaceuticals' ALS drug, Relyvrio, was approved
by the FDA.
Amylyx was funded in part by the "Ice Bucket Challenge,"
which went viral online in 2014.
Relyvrio is the third drug
approved for the treatment of ALS.
But on the same day, Verdiperstat, an ALS drug from Biohaven, declared a phase III trial failed
.
Verdiperstat was introduced from AstraZeneca in 2018 and was being studied
with multiple experimental ALS drugs at Massachusetts General Hospital.
However, compared with placebo, the drug failed to make progress
in disease progression or survival.
In May, Biohaven struck a major deal with Pfizer, which acquired Biohaven's migraine products
for $11.
6 billion.
Biohaven has not said whether Verdiperstat will continue to be developed for other indications, but only one is currently in phase III clinical trials, a treatment for obsessive-compulsive disorder with data
scheduled to be reported later this year.
Just days after Biohaven's announcement, Clene Nanomedicine also reported that its ALS drug failed to meet the primary and secondary endpoints
in a phase II trial.
Clene Nanomedicine is currently looking for a strategic partner for the product to advance efficacy trials
at different doses.
3 Novartis anti-inflammatory drug "falls" in phase III for the third time
3 Novartis anti-inflammatory drug "falls" in phase III for the third time Novartis has an ambitious goal in the field of oncology, developing treatments that can prevent cancer in high-risk people, especially immune-targeted drugs
that regulate inflammation.
Novartis believes this could be the "next frontier" in treating cancer
.
However, efforts to use its anti-inflammatory rare disease drug called Canakinumab in cancer treatment have failed to achieve the desired results
.
Canakinumab has been approved for the treatment of 3 rare and unique types of periodic fever syndromes
.
In August, Novartis said Canakinumab failed in its third trial against non-small cell lung cancer (NSCLC), which was recently being tested
to prevent tumor recurrence after surgery.
This is
Canakinumab's third failed phase III trial.
In 2018, the FDA refused to approve Canakinumab's application for a new indication as a preventive treatment for certain heart diseases, and now Novartis also seems to be deadlocked
in expanding the drug's use in NSCLC.
Analysts at Jefferies had predicted that expanding the approval could boost Canakinumab's sales to $2 billion
.
The company is conducting another trial of the drug against lung cancer, and an oncologist recently told Bloomberg that Canakinumab's anti-inflammatory properties could still make it a "good model"
for cancer prevention targeting the right patient population.
4 Intercept suffered another setback against the NASH pipeline
4 Intercept suffered another setback against the NASH pipeline Nonalcoholic steatohepatitis (NASH) is considered a "graveyard of drug development" and has long failed to make significant progress
.
This huge market of about $35 billion has prompted a race to develop the first approved drug
.
NASH is a metabolic disorder, usually due to obesity (rather than alcohol intake), which can lead to scarring, cirrhosis, and even liver failure
.
Intercept Pharmaceuticals' Obecholic acid drug, Ocaliva, is being trialed for several indications related to NASH and was previously approved for biliary cirrhosis
.
For more than a year, Intercept has been in communication
with the FDA about pushing for Ocaliva approval for patients with liver fibrosis caused by NASH.
Recently, the company's failed trial in patients with compensated cirrhosis caused by NASH has further complicated drug development in the field
.
M.
, President of R&D and Chief Medical Officer of Intercept Michelle Berrey said: "Achieving statistical significance in the histological endpoint of compensated cirrhosis due to NASH in clinical trials is a very high threshold
.
”
, President of R&D and Chief Medical Officer of Intercept Michelle Berrey said:
On September 30, the Intercept announced that Ocaliva had failed to meet the primary endpoint
in the Reverse trial.
The company said in a statement that the results will not affect Ocaliva's NDA program for liver fibrosis, which has positive
Phase III results.
The Intercept plans to file an NDA
by the end of the year.
Several other companies, including Novo Nordisk, Alnylam and its partners Regeneron and Akero Therapeutics, also have NASH projects
.
5 Relmada depression medication missed the primary endpoint
5 Relmada depression medication missed the primary endpoint In recent years, the field of research and development of new psychedelics-based drugs for depression has been revitalized, such as Johnson & Johnson's ketamine nasal spray Spravato and Axsome Therapeutics' Auvelity, the latter of which was approved in August as the first fast-acting oral drug
for the treatment of major depressive disorder.
Relmada Therapeutics has also been working on the indication of REL-1017
.
A novel NMDA receptor (NMDAR) antagonist, REL-1017 (dexmethadone), blocks the "hyperactive NDMAR channel.
"
If the drug succeeds, Relmada thinks this "new approach" could provide another option for a quick treatment for
depression.
However, Relmada announced this month that a phase III study of REL-1017 for major depressive disorder (MDD) failed to meet its primary endpoint
at the end of the four-week course of treatment due to a higher-than-expected placebo response.
News of the failed trial caused the company's stock price to plummet nearly 80 percent
.
Relmada is now pinning its hopes on the performance of REL-1017, the company's only significant product, and in two other phase III trials, REL-1017 will be tested
alongside other depression medications.
Relmada said the positive results of these studies may be enough to file an application
with the FDA.
However, any failure could spell doom for Relmada, whose other development projects include "psilocybin and its derivatives"
acquired through acquisitions.
There are still few promising drug candidates for depression
.
An analysis late last year showed that there are only nine drug candidates for phase II or III trials that have a positive effect on depression, and innovation is still needed in the field
.
References:
References: References:1、5 impactful drug trial failures from the last year； pharmavoice
1、5 impactful drug trial failures from the last year； pharmavoice
