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18:39 EST Amgen presents end-of-treatment data from Phase 2 OCEAN(a)-DOSE study - Amgen presented end-of-treatment data from its Phase 2 OCEAN(a)-DOSE study of investigational olpasiran in adults with elevated lipoprotein(a) levels and a history of atherosclerotic cardiovascular disease. The study was designed to assess safety, tolerability and optimal dose of olpasiran in adults with established ASCVD to reduce Lp(a). OCEAN(a)-DOSE is a multicenter, randomized, double-blind, placebo-controlled dose-finding study of olpasiran in 281 patients with established ASCVD and Lp(a) levels greater than150 nmol/L. Patients were randomized to one of four doses of olpasiran or placebo, given subcutaneously. Across cohorts, the median baseline Lp(a) concentration was 260.3 nmol/L. Patients who received 75 mg or higher every 12 weeks had a 95% or greater reduction in Lp(a) compared to placebo at week 36. At these doses, more than 98% of patients achieved an Lp(a) level of 125 nmol/L or less at week 36. Overall, the rates of adverse events were similar in the olpasiran and placebo arms. The most common treatment-related adverse events were injection site reactions, primarily pain. At week 36, Lp(a) increased by a mean of 3.6% in the placebo arm, whereas there were substantial reductions of Lp(a) levels in all of the olpasiran arms. Placebo-adjusted mean percent reductions were 70.5% for 10 mg every 12 weeks, 97.4% for 75 mg every 12 weeks, 101.1% for 225 mg every 12 weeks and 100.5% for 225 mg every 24 weeks.

16:42 EST iRhythm announces new health economic analysis of mSToPS study - iRhythm Technologies announced a new health economic analysis of the mSToPS study, presented at the American Heart Association's 2022 Scientific Sessions event. The study, titled "Cost-Effectiveness of AF Screening with Two-Week Patch Monitors: The mHealth Screening to Prevent Strokes Study," evaluated the cost-effectiveness of screening for atrial fibrillation with Zio XT. The analysis found that systematic screening for AFib in an at-risk population with the iRhythm Zio XT patch provided high value from a health economic perspective. mSToPS was a landmark direct-to-participant randomized clinical trial combined with a prospective matched observational cohort study. The study, published in the Journal of the American Medical Association in 2018 and conducted at the Scripps Research Translational Institute in partnership with Aetna and Janssen Pharmaceuticals, found that Zio XT-based screening was associated with increased detection of AFib, greater use of outpatient cardiology care, and a higher rate of initiation of stroke prevention therapy. A three-year follow-up analysis of the mSToPS study, published in PLOS One in 2021, found that screening with Zio XT was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort.

16:35 EST Intercept announces two analyses assessing potential of OCA in PBC - Intercept Pharmaceuticals announced that results from two analyses assessing the potential of obeticholic acid, or OCA, to improve outcomes for patients with primary biliary cholangitis, or PBC, including death, liver transplant and hepatic decompensation, will be presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases. The "Efficacy of Obeticholic Acid (OCA) vs. Placebo and External Control (EC) on Clinical Outcomes in Primary Biliary Cholangitis (PBC)" analysis assessed the effect of OCA treatment on time to first occurrence of PBC disease progression, liver transplant or death of OCA-treated subjects in the Phase 3b/4 COBALT trial compared to placebo and compared to a non-OCA-treated external control group created from the Komodo Health U.S. claims database. COBALT was a randomized, double-blind, placebo-controlled confirmatory trial designed to assess efficacy and safety of OCA in patients with advanced PBC. As previously disclosed, the study was terminated in December 2021, before it was fully enrolled, for lack of feasibility. The placebo-controlled analysis of COBALT showed no statistically significant difference in either the Original Primary Composite Endpoint or the FDA Expanded Primary Endpoint, which also included additional liver-related events. In anticipation of feasibility challenges, the COBALT analysis plan included an EC group as a second comparator arm. The EC group, created from Komodo Health claims database, had to meet COBALT inclusion and exclusion criteria and were weighted using propensity score-derived standardized morbidity ratios. The EC group was comparable to OCA-treated patients in COBALT on all measured baseline variables. Endpoints in this comparison were the same as in the primary analysis of the COBALT trial to the extent possible; however certain variables, such as MELD, were not available in the Komodo database and thus not included. Results from the EC group as-treated analysis showed statistical significance in both the original and the FDA-expanded primary endpoints comparing the OCA-treated subjects in COBALT with the non-OCA-treated patients in EC: From the Original Primary Composite Endpoint: 17 events occurred in subjects in the COBALT OCA arm and 35 in patients from the non-OCA-treated EC arm, reflecting a 61% reduction in risk of events at any time during follow-up. From the FDA Expanded Primary Endpoint: 28 events occurred in subjects in the COBALT OCA arm and 46 in patients from the non-OCA-treated EC arm, reflecting a 52% reduction in risk of events at any time during follow-up. HEROES-US leveraged the Komodo Health database in a fully real-world study to assess the potential benefits of OCA treatment on death, liver transplant and hospitalization for hepatic decompensation in PBC patients with compensated liver disease. The study looked at a pre-defined group of patients with PBC who were treated with OCA and a comparable group of PBC patients who were eligible, but who were not treated with OCA. Characteristics of patients who initiated treatment with OCA were SMR-weighted to OCA-eligible patients not treated with OCA. A statistically significant and clinically meaningful reduction in all-cause death, liver transplant, or hospitalization for hepatic decompensation was seen among OCA-treated patients compared to the control group who were not treated with OCA. Treatment with OCA resulted in a 63% reduction in relative risk for death, liver transplant and hospitalization for hepatic decompensation. Results were consistent with those observed for comparable endpoints in the POISE trial open-label extension vs. Global PBC patient registry external controls, and the COBALT trial vs. Komodo EC.

09:28 EST Intellia presents interim data from cardiomyopathy arm of Phase 1 study of '2001 - Intellia Therapeutics (NTLA) presented additional interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an investigational, in vivo CRISPR/Cas9 genome editing therapy in development as a single-dose treatment for transthyretin amyloidosis in collaboration with Regeneron Pharmaceuticals (REGN). Results were presented in a Late-Breaking Science oral presentation at the American Heart Association Scientific Sessions 2022, held November 5 - 7 in Chicago, Illinois. The interim data from the dose-escalation portion of the Phase 1 study include 12 adult patients with ATTR amyloidosis with cardiomyopathy with New York Heart Association Class I - III heart failure. The data presented were as of a data cutoff date of August 25, 2022. Single doses of 0.7 mg/kg and 1.0 mg/kg of NTLA-2001 were administered via a single intravenous infusion, and the change from baseline in serum transthyretin protein concentration was measured for each patient. Administration of NTLA-2001 led to deep and durable reductions in serum TTR by day 28. These deep reductions in serum TTR were sustained through the observation period, with patient follow-up ranging from four to six months. These data highlight NTLA-2001's potential as a one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein in people with ATTR-CM. At both dose levels, NTLA-2001 was generally well tolerated. As previously reported, two of 12 patients reported transient infusion reactions, which were the only observed treatment-related adverse events. One patient in the 0.7 mg/kg dose NYHA Class III cohort experienced a Grade 3 infusion-related reaction, which resolved without clinical sequalae. Per the study protocol, this group was subsequently expanded from three to six patients to further characterize safety at this dose level. No additional patients in the 0.7 mg/kg dose NYHA Class III cohort reported a treatment-related adverse event. No clinically significant laboratory abnormalities were observed at either dose level. The Phase 1 study, run by Intellia as the program's development and commercialization lead as part of a multi-target collaboration with Regeneron, is evaluating NTLA-2001 in patients with either ATTR-CM or hereditary ATTR amyloidosis with polyneuropathy. Dosing at 55 mg, the fixed dose corresponding to 0.7 mg/kg, is ongoing in Part 2, the dose-expansion portion of the study. Intellia remains on track to complete, by the end of this year, planned enrollment of both arms of the Phase 1 study that will inform the dose selection for subsequent pivotal studies.

09:21 EST Lexicon presents post hoc analysis of results from SCORED Phase 3 outcomes trial - Lexicon Pharmaceuticals announced that a new post hoc analysis of results from the SCORED Phase 3 outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the American Society of Nephrology Kidney Week 2022 annual scientific meeting in Orlando, Florida. The presence of albuminuria in patients with or without diabetes is associated with an increased risk for adverse renal and cardiovascular outcomes. Urine albumin-to-creatinine ratio is commonly used as a surrogate to assess kidney risk. SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke. SCORED achieved its primary endpoint, with overall tolerability similar to placebo. Results were presented at the Late-Breaking Science Session of the American Heart Association Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine in an article titled: "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease."