Tag: clinical trials

Categories : Mental Health New Compounds and TreatmentsTags :

Neurocrine’s Anticipated Schizophrenia Drug Flops in Clinical Trial

On By ModernMedia

Pharmaeceutical company Neurocrine’s anticipated schizophrenia drug, luvadaxistat, failed to have an impact on negative symptoms in a key clinical trial, but still showed promising cognitive benefits.

Neurocrine Biosciences had licensed seven of Takeda’s psychiatry drugs last year for over $2 billion. Luvadaxistat was the furthest along, having entered Phase 2 testing in 2017.

The experimental drug is supposed to help schizophrenia patients cope with “negative symptoms”—a range of difficult-to-treat conditions such as lack of motivation, trouble communicating and limited emotion. The drug is designed to block an enzyme that degrades a certain kind of amino acid important for brain function.

However, according to results from a mid-stage study, in comparison to placebo, patients treated with the drug didn’t perform significantly better, as measured by a scale that assesses the severity of negative symptoms.

While there was excitement around the science behind luvadaxistat, Wall Street analysts lost much of their optimism in the programme last month, after Concert Pharmaceuticals halted development of CTP-692, an experimental drug based on the same mechanism, after trials also saw disappointing results. 

Nevertheless, there remains a path ahead for luvadaxistat as Neurocrine is setting up to analyse the drug’s efficacy for cognitive benefits, as it appears that these results at least were in line with scientific predictions.

Source: BioPharma Dive

Categories : COVID VaccinesTags :

Questions Raised over Oxford’s Unusual Vaccine Regimen

On By ModernMedia

The recent announcement of the Oxford’s and AstraZeneca’s vaccine trial being 70% effective up to 90% effective has raised some pointed questions.

The trial had two treatment arms, one receiving two full doses of the AZD1222 vaccine and a half dose plus a full dose, with the doses being administered 28 days apart. The “half dose then full dose”  treatment arm reported the 90% protection. The problem was that the trial was never meant to have such an arm. 

It was noticed that some participants were only receiving a half dose because they were experiencing fewer effects than expected such as arm pain and headache. This was subsequently corrected so that they would still receive the full dose on the second administration.

Of particular concern is that the “90% effectiveness” is based on a much smaller subset of the trial participants, with a correspondingly higher statistical uncertainty. So much so that there is statistical overlap with their lower effectiveness of 62% quoted for the two full doses. Furthermore, the participants were from the initial stages of the vaccine trial, where they were aged 18-55 and therefore have little applicability to the results of the main trial which included older age groups as well. 

The details of exactly why the half-measure doses came to be administered in the first place have not been revealed by Oxford or AstraZeneca. Meanwhile in the US, a Phase III of the trial is being rolled out with 40 000 participants, and the “half dose then full dose” regimen may be included – however, uncertainty about it and whether it isn’t a statistical fluke will have to be cleared up first.

Source: Ars Technica