Today’s Daily Dose brings you news about Akero’s big day; Immunovant’s Thyroid Eye Disease trial results; Court ruling in Amarin’s patent suit related to Vascepa, Savara’s update on its ongoing clinical trials in light of the coronavirus crisis; Johnson & Johnson’s progress in its COVID-19 vaccine program.
Akero Therapeutics Inc. (AKRO) is all set to announce results from the ongoing phase IIa study of its investigational drug AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis, or NASH, on Tuesday, March 31, 2020, before the market opens.
The phase IIa study, dubbed BALANCED, is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating AKR-001 in biopsy-confirmed patients with NASH.
The trial involves 80 patients who are randomized to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20.
The primary efficacy endpoint for the study is an absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include the change from baseline in ALT (alanine transaminase, a liver enzyme) at 12 weeks, the number of patients who had a decrease of more than 2 points in the NAFLD activity score at 24 weeks and safety and tolerability measures.
AKRO closed Monday’s trading at $17.18, up 6.58%.
Shares of Amarin Corporation plc (AMRN) slumped more than 60 percent in extended trading on Monday, after the Company lost the patent suit, which it had filed against generic competitors Dr. Reddy’s and Hikma Pharmaceuticals.
Dr. Reddy’s and Hikma Pharmaceuticals had filed abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA capsule franchise.
Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of cardiovascular events.
The drug brought in annual sales of $427 million for Amarin in 2019 compared to $228 million in 2018. According to the Company, Vascepa is said to have patent coverage until 2030.
Commenting on the court ruling, John F. Thero, president and chief executive officer of Amarin said, “Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of VASCEPA in the United States.”
AMRN closed Monday’s trading at $13.58, up 2.57%. In after-hours, the stock fell 66.86% to $4.50.
Axsome Therapeutics Inc.’s (AXSM) phase III trial of AXS-05 in treatment-resistant depression, dubbed STRIDE 1, has failed to reach statistical significance in the primary endpoint, i.e. the MADRS change from baseline to End of Study (6 weeks).
MADRS or Montgomery-Åsberg Depression Rating Scale is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. (Source: ClinicalTrials.gov).
However, the trial met key secondary endpoints demonstrating rapid and statistically significant improvements in depressive symptoms on MADRS versus active comparator at Weeks 1, 2, and overall.
The Company also announced that it is on track to file an NDA in the fourth quarter for AXS-05 in the treatment of major depressive disorder.
Data readout from INTERCEPT Phase 3 trial of AXS-07 in the early treatment of migraine is expected very soon while that from ADVANCE-1 Phase 2/3 trial of AXS-05 in Alzheimer’s disease agitation is expected in the early second quarter.
AXSM closed Monday’s trading at $57.58, down 8.99%.
Biohaven Pharmaceutical Holding Company Ltd.’s (BHVN) pivotal clinical trial evaluating oral Rimegepant 75 mg for the preventive treatment of migraine in both episodic and chronic migraine patients has yielded positive topline results.
The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with oral Rimegepant compared with placebo.
In February of this year, oral Rimegepant 75 mg was approved by the FDA for the acute treatment of migraine in adults. The drug, under brand name NURTEC ODT, was launched on March 12, 2020.
BHVN closed Monday’s trading at $33.31, down 5.58%.
Shares of Immunovant Inc. (IMVT) jumped more than 20 percent on Monday, following encouraging initial results from its ongoing phase IIa study of IMVT-1401 in patients with Thyroid Eye Disease, also known as Graves’ ophthalmopathy.
The trial, dubbed ASCEND GO-1, involved seven adult patients with moderate-to-severe active Thyroid Eye Disease who were treated with two weekly 680mg subcutaneous doses of IMVT-1401 followed by four weekly 340mg subcutaneous doses of IMVT-1401.
According to the initial results, the mean reduction in total IgG levels from baseline to end of treatment was 65%. As evaluated at the end of treatment, four out of the seven patients improved by 2 or more than 2 points on the Clinical Activity Score. Of six patients with baseline diplopia (double vision), 4 patients (67%) demonstrated improvement in diplopia, noted the Company.
IMVT-1401 was safe and generally well-tolerated with no serious adverse events.
Horizon Therapeutics’ (HZNP) Tepezza, approved in January of this year, is the first and only drug for the treatment of adults with thyroid eye disease.
IMVT closed Monday’s trading at $16.55, up 23.14%.
Johnson & Johnson (JNJ) has selected a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020.
The Company expects to initiate phase I human clinical studies of its lead vaccine candidate at the latest by September 2020. The first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process, JNJ noted.
Through a landmark new partnership, BARDA and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.
JNJ closed Monday’s trading at $133.01, up 8.00%.
Reata Pharmaceuticals’ (RETA) phase III study of bardoxolone methyl in patients with connective tissue disease-associated pulmonary arterial hypertension, dubbed CATALYST, and the open-label extension study of bardoxolone in patients with PAH, dubbed RANGER, are being closed.
The decision to stop the CATALYST trial is based on the initial review of available efficacy data provided by the Data and Safety Monitoring Board (DSMB), which suggested that the study is unlikely to meet the primary endpoint of improvement in six-minute walk distance compared to placebo at Week 24.
The Company has temporarily paused enrollment of new patients in the Phase 3 FALCON trial of bardoxolone in patients with autosomal dominant polycystic kidney disease.
However, the phase III CARDINAL trial of bardoxolone in patients with chronic kidney disease caused by Alport syndrome is fully enrolled and ongoing.
RETA closed Monday’s trading at $161.88, up 7.93%.
Savara Inc. (SVRA) has terminated enrollment in its AVAIL and ENCORE studies due to the ongoing COVID-19 pandemic.
AVAIL is a phase III study evaluating AeroVanc in people living with cystic fibrosis who have methicillin-resistant Staphylococcus aureus (MRSA) lung infection. Total target enrollment was 200 patients. A total of 188 patients have been enrolled. Topline results from the study are still expected in early 2021.
ENCORE is a phase IIa study evaluating Molgradex in nontuberculous mycobacterial lung infection in people living with cystic fibrosis. Total target enrollment was approximately 30 patients and 14 patients are currently enrolled.
SVRA closed Monday’s trading at $2.35, up 9.30%. In after-hours, the stock was down 7.66% at $2.17.
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