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.
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 Alder, Teva 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)|
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.