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trial failure

Sage Therapeutics' depression drug falls short at Phase 3

Sage Therapeutics has announced that its candidate SAGE-217 flopped in Phase 3 trials investigating its efficacy in symptom reduction for major depressive disorder (MDD) in adult patients.

The drug failed to meet its primary endpoint of significant reduction from baseline in MDD symptoms, as measured on the 17-item Hamilton Rating Scale for Depression (HAM-D) after 15 days of treatment.

Halozyme culls staff by 55% following Phase 3 metastatic pancreas cancer failure

Halozyme Therapeutics has announced it is to cull its workforce by more than half in the wake of the news that its investigational candidate PEGPH20 failed at Phase 3 in the first-line treatment of metastatic pancreas cancer.

The company revealed that the candidate failed to present median overall survival benefit when combined with gemcitabine and Abraxane (nab-paclitaxel) compared to gemcitabine and Abraxane alone, presenting only 11.2 months benefit compared to 11.5 months. As a result, further development in the study is to be terminated.

Catalyst's lead candidate Firdapse falls short in Congenital Myasthenic Syndromes

Catalyst Pharmaceuticals has made it known that its lead product Firdapse (Amifampridine Phosphate) fell short of its primary endpoint in the symptomatic treatment of genetically confirmed Congenital Myasthenic Syndromes (CMS) in patients over the age of two years old.

In what was the first trial of its kind in genetically confirmed CMS patients, individual patient improvements were observed but ultimately meet its goal of subject global impression – the study’s primary endpoint – or its secondary endpoint of muscle function measure, across all tested subtypes.

Acceleron terminates drug candidate following facioscapulohumeral muscular dystrophy failure

Acceleron Pharma has seen its stock fall by almost 4% after it unveiled new Phase 2 data confirming that its investigational therapy ACE-083 failed to meet its functional secondary endpoints in the treatment of facioscapulohumeral muscular dystrophy (FSHD).

The trial results showed that the therapy actually successfully achieved its primary endpoint, demonstrating a robust, statistically significant increase in mean total muscle volume, but this failed to translate into statistically significant improvement in functional tests.

Pfizer's Lyrica fails at Phase 3 in treating primary generalised tonic-clonic (PGTC) seizures

Pfizer has unveiled new Phase 3 data on the effectiveness of Lyrica (pregabalin) in the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients between the ages of five and 65 years old, revealing that the therapy failed to meet its primary endpoint.

Specifically, Pfizer announced that use of the drug did not lead to a statistically significant reduction in seizure frequency compared to placebo in testing of 219 participants. However, the manufacturer did note that the drug’s safety profile was consistent with previous findings.

AbbVie terminates Phase 3 brain cancer study after Depatux-M shows no benefit

AbbVie has terminated a Phase 3 study of the efficacy of Depatux-M (depatuxizumab mafodotin) in the treatment of newly diagnosed glioblastoma (GBM) in patients whose tumours have epidermal growth factor receptor (EGFR) amplification, after it was identified in an interim analysis that the therapy presented no survival benefit to patients.

Boehringer's Pradaxa fails to meet Phase 3 endpoint in preventing recurrent stroke

Boehringer has announced that Pradaxa (dabigatran etexilate mesylate) has failed to meet its primary endpoint in its Phase 3 study, proving unable to show superiority over acetylsalicylic acid (ASA) in preventing recurrent stroke in patients with embolic stroke of undetermined source (ESUS).

The drug particularly failed to present a statistically significant difference in the risk of recurrent stroke. The manufacturer did, however, note that after one year of treatment, a trend emerged showing Pradaxa to improve this very metric over ASA.

BMS blockbuster Opdivo falls short at Phase 3 in MGMT-unmethylated glioblastoma multiforme

Bristol-Myers Squibb’s blockbuster immunotherapy Opdivo (nivolumab) has hit a hurdle, failing its primary endpoint in a Phase 3 trial investigating its efficacy in the treatment of newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme (GBM).

Data from the trial revealed that the drug, when used in combination with radiation, did not sufficiently improve overall survival (OS). However, Opdivo’s safety profile was found to be consistent with previous studies.

Allergy Therapeutics' adjuvanted birch allergoid drug shocks with Phase 3 failure

UK-based biotech firm Allergy Therapeutics has been left disappointed after it became evident that its adjuvanted birch allergoid product failed its primary endpoint in the treatment of birch-pollen induced seasonal allergic rhinitis.

Newly revealed Phase 3 data indicated that the drug “did not show a statistically significant difference between active and placebo arms”, with trial participants failing to achieve an adequate combined symptom medication score averaged over the peak birch pollen season.

Lilly's Lartruvo/chemo combo surprises with Phase 3 failure in soft tissue carcinoma

Eli Lilly has reluctantly pulled back the curtain on new Phase 3 data for its platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody Lartruvo (olaratumab), revealing that the therapy failed to present clinical benefit in the treatment of advanced or metastatic soft tissue sarcoma (STS) when used in combination with standard of care chemotherapy drug doxorubicin, compared to doxorubicin alone.

The ANNOUNCE study sought to determine the overall survival (OS) benefit of the combination – it’s primary endpoint.

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