Roche/Sanofi treatment combo improves survival rates in COVID-19 – Study
A combination of drugs from Sanofi (NASDAQ:SNY) and Roche (OTCQX:RHHBY) has improved the survival rates and sped up the recovery in critically ill COVID-19 patients, Daily Mail reports, quoting the results of a study published online today.
Based on a trial involving 3,900 patients, the combo of Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) have reduced the mortality rates by 8.5 percentage points among patients hospitalized and severely ill with the disease. Both Actemra and Kevzara are Interleukin-6 (IL-6) receptor antagonists and approved for moderately to severely active rheumatoid arthritis.
The death rate has stood at 35.8% in a control group compared to 27.3% among patients receiving either tocilizumab or sarilumab, according to study data that are not yet peer-reviewed.
In the study run across 15 countries, the patients treated with either treatment have recovered swiftly, and were discharged from intensive care units around seven to 10 days earlier than those who did not get these drugs, said Anthony Gordon, a professor from Imperial College London who co-led the study.
Dynavax’s Hepatitis B vaccine shows encouraging action in ongoing hemodialysis trial
Dynavax (DVAX +7.0%) has announced final immunogenicity and interim safety results from ongoing trial evaluating Hepatitis B vaccine candidate, HEPLISAV-B in patients undergoing hemodialysis.
Immunogenicity data in 119 patients with end-stage renal disease undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis.
Interim safety data showed Hep-B vaccine candidate was well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.
The study is evaluating a new 4-dose regimen of HEPLISAV-B and is designed to evaluate the immunogenicity at study week 20 and safety over the 68-week study duration. Safety and effectiveness of HEPLISAV-B have not been established.
Itamar Medical sees Q4 revenue above consensus
Itamar Medical (NASDAQ:ITMR) +2% premarket, expects Q4 revenue in the range of $12.5M-$12.8M, reflecting growth of 28%-31% and above consensus of $11.71M; WatchPAT revenue of $12M-$12.3M, representing growth of 32%-35%; U.S. WatchPAT revenue of $10M-$10.3M, representing growth of 36% to 40%.
FY2020 revenue to grow ~31% to $40.8M-$41.1M vs. consensus of $39.78M.
“Following a strong Q3, we were pleased to see that trend continue into the fourth quarter, largely driven by our U.S. core sleep business from both existing customers as well as new customers nationwide. We continue to believe that the shift to home-based care has accelerated our plans of reaching many of the 80% undiagnosed patients estimated to have sleep apnea in the U.S. and other parts of the world,” said Gilad Glick, President and Chief Executive Officer of Itamar Medical.
Teva’s risperidone injection shows positive action in schizophrenia patients
Teva Pharmaceuticals (NYSE:TEVA) and MedinCell (OTCPK:MDCLF) announce positive results for study TV46000-CNS-30072 (the RISE study), a Phase 3 clinical trial designed to evaluate the efficacy of TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) as a treatment for patients with schizophrenia.
In the RISE study, patients treated with risperidone injection either monthly (q1M) (n=183) or once every two months (q2M) (n=179) experienced a statistically significant delay in time to relapse versus placebo (n=181), the study’s primary endpoint, with p<0.0001 for each comparison.
Both, q1M and q2M demonstrated a reduction of 80.0% and 62.5% in the risk to relapse compared to placebo, respectively. The safety profile is consistent with other risperidone formulations.
Sarepta plunges as DMD gene therapy treatment fails to meet primary endpoint
Sarepta Therapeutics (NASDAQ:SRPT) has announced top-line results from Part 1 of Study SRP-9001-102 (Study 102) evaluating, SRP-9001 in 41 patients with Duchenne muscular dystrophy (DMD). With company failing to meet the primary endpoint with statistical significance, the shares are trading -53.8% lower in the post-market.
SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene, to muscle tissue, needed for muscle membrane stability.
Patients treated with SRP-9001 showed an increase in NSAA total score (functional skills) compared to placebo at 48 weeks, though the study failed to achieve statistical significance on the primary functional endpoint of improvement in NSAA total score compared to placebo at 48 weeks post-treatment.
In participants aged 4-5 years, SRP-9001 demonstrated a statistically significant improvement in NSAA total score versus the age-matched placebo cohort, achieving a 4.3-point improvement from baseline, at 48 weeks.
