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Upcoming events – Migraine data for Amgen while Neurocrine looks to Tourette’s

Upcoming events – Migraine data for Amgen while Neurocrine looks to Tourette’s

Source EP Vantage
Company AmgenNeurocrine Biosciences 
Tags Analysis, Central Nervous System, Phase II, Phase III, Monoclonal Antibody, Free Content, Event - Open
Date September 09, 2016


Welcome to your weekly digest of approaching regulatory and clinical readouts. Phase III data are expected in the fourth quarter for Amgen ’s CGRP -targeting antibody erenumab  in episodic migraine, and with a marginally positive result already accomplished in the chronic form of the disease,  Amgen  needs to move fast to stay ahead of the competition.

And Neurocrine is expecting readouts from phase II trials of valbenazine  in Tourette’s syndrome. While this would add another string to  valbenazine ’s bow the main focus remains on its use in tardive  dyskinesia , where the big forecasts lie, and which could determine whether a partner will hop aboard.

Migraine

Amgen ’s erenumab , also known as AMG 334 , is in two phase III episodic migraine trials called Strive and Arise in 955 and 577 patients, respectively . Patients have four to 15 migraine days per month and fewer than 15 headache days per month.

Strive is testing once-monthly 70mg and 140mg subcutaneous erenumab  doses versus placebo. The Arise trial is again placebo controlled, but tests one dose of  erenumab  followed by an open-label phase. The primary outcome for both trials is change in mean monthly migraine days. Secondary measures include the proportion of subjects with at least 50% reduction from baseline in monthly migraine days.

Phase II results in the chronic form showed a small benefit, with the project cutting the number of monthly migraine days to about 11.4, just 2.4 days better than placebo. A high placebo response is not unusual in migraine trials, and Amgen  and its ex-US partner  Novartis  said the results were statistically significant, but at the time did not reveal the level of significance.

Although cross-study comparisons cannot really be relied on, a similar benefit has been reported from competitors AlderTeva  and Lilly  (Marginal migraine benefit puts Amgen and Novartis in pole position, 9 June, 2016).

Further data will be presented at the European Headache and Migraine Trust International Congress in Glasgow, UK, on September 15-18. The company has previously said it would file all the available chronic and episodic data in one package.

2022 worldwide sales of erenumab  are forecast to reach $475m, according to sellside consensus from  EvaluatePharma. With analysts pegging Teva ’s CGRP  inhibitor to be the big seller by 2022  Amgen  needs to play on its first-mover advantage.

CGRP  inhibitors in phase III development 
Project  Company  Approval expected  2022e sales ($m) 
TEV-48125   Teva   2018  1,069 
ALD403   Alder  Biopharmaceuticals   2018  993 
Galcanezumab   Eli Lilly   2017  484 
Erenumab /AMG  334  Amgen /Novartis  2017  475 

Tourette’s

Neurocrine’s valbenazine tosylate , previously called NBI-98854 , is now branded Ingrezza. Two phase II placebo-controlled trials, T-Forward and T-Force Green, are under way respectively  in adults and children with Tourette’s syndrome.

The studies are recruiting up to 90 subjects each, and data are expected before the end of the year. Two doses, given once daily for six weeks in the paediatric trial or eight weeks in the adult study, are being tested versus placebo. The primary endpoint is the severity of tic symptoms assessed by a global scale.

An open-label study for those completing the two trials has also been launched. Ingrezza is a VMAT2  inhibitor also in phase III for  tardive  dyskinesia , its more valuable indication. It is solely owned by Neurocrine, and has some hefty forecasts attached to it with 2022 sales expected to reach $1.3bn, according to EvaluatePharmaconsensus.

74% of 2022 forecasts are assigned to its dyskinesia  indication, which was recently filed with the FDA. With a breakthrough therapy designation attached approval could come as early as the second quarter of next year, and potential buyers will be watching with interest.

Project  Study  Trial ID 
Erenumab   Strive
Arise 
NCT02456740
NCT02483585 
Ingrezza  Adult trial
Paediatric
Open-label 
NCT02581865
NCT02679079
NCT02879578