Abivax stops phase 2b/3 miR-AGE Covid-19 trial due to lack of efficacy

 Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company modulating the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that it is halting the miR-AGE phase 2b/3 clinical trial in high-risk Covid-19 patients after the independent Data Safety and Monitoring Board (DSMB) recommendation for lack of efficacy.

The multinational miR-AGE ABX464 phase 2b/3 clinical trial (ABX464-401), has already recruited 500 high-risk Covid-19 patients out of the planned 1,034 and has been declared "Research National Priority" by the French government in December 2020. The study has a robust randomized, double-blind and placebo-controlled design to test whether ABX464 could prevent the development of severe Covid-19 disease in the participants. The DSMB recommendation is based on a planned, interim analysis evaluating data of 305 high-risk Covid-19 patients who completed the study period. The comparison of the data generated in the patient group treated with ABX464 versus the placebo group, did not show a difference in the rate of severe disease between the placebo group and the ABX464 group. Importantly, ABX464 was well tolerated and safe in these high-risk Covid-19 patients.

Eric Cua, M.D., infectious disease specialist at the University Hospital Center (CHU) of Nice and principal coordinator of the miR-AGE trial in France, said: The very well designed and conducted miR-AGE study aimed at preventing severe acute disease characterized by hyperinflammation and cytokine storm. Thanks to the robust study design, we can rely on the outcome of the interim analysis that showed the futility of the trial. The analysis also confirms the good safety of ABX464. The low rate of severe disease in this high-risk population was unexpected, however, it is good news about the prognosis of high risk Covid-19 patients with the current standard of care and with emerging variants."

https://www.pharmiweb.com/press-release/2021-03-05/abivax-follows-dsmb-recommendation-to-stop-the-phase-2b3-mir-age-covid-19-clinical-trial-due-to-lac

EU regulator advises on use of Lilly's COVID-19 antibody cocktail

 Europe's medicines regulator said on Friday Eli Lilly and Co's antibody drug combination can be used to treat COVID-19 patients who do not require oxygen support and are at high risk of progressing to severe illness.

The recommendation can now be used as guidance in individual European nations on the possible use of the combination of bamlanivimab and etesevimab, before a broader approval is given, the European Medicines Agency (EMA) said. (https://bit.ly/3kMpkZr)

The medicines in the cocktail, given via a drip, belong to a class of drugs known as monoclonal antibodies, which are synthetically manufactured copies of infection-fighting proteins produced naturally by the human body.

The EMA said while results indicated the combination reduced the amount of virus present in the back of the nose and throat, there was some uncertainty around the benefits of using bamlanivimab alone. However, the regulator did not rule out the monotherapy as a possible option.

"In terms of safety, most side effects reported were mild or moderate; however, reactions related to the infusion (including allergic reactions) are likely and should be monitored for," the EMA said.

The results also indicated that the combination and monotherapy led to fewer coronavirus-related medical visits.

The combination was granted U.S. emergency use authorisation last month after a late-stage trial showed the therapies together helped cut the risk of hospitalisation and death in COVID-19 patients by 70%.

The EMA's advice on Lilly's therapy follows similar guidance on Regeneron Pharmaceuticals Inc's antibody treatment last month. The European regulator is currently reviewing a COVID-19 antibody drug from South Korea's Celltrion.

https://finance.yahoo.com/news/1-eu-regulator-advises-lillys-172954536.html

Phase 2 Underway for Innovation Pharma’s Brilacidin for COVID-19

 Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reports that eight sites are now participating in the Company’s international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19.

The trial is now posted on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04784897), which shows seven sites as recruiting and enrolling patients. An eighth site is also now enrolling in addition, and the Company has informed clinicaltrials.gov of the change in status. Fifteen patients have already been dosed in the trial. More sites are coming online, which is expected to further accelerate enrollment and treatment. 

The trial doesn’t exclude any variants of SARS-CoV-2, the virus responsible for COVID-19. Virulent coronavirus strains have scoured different countries around the world recently, including highly contagious versions, such as P1 and B.1.1.7. Brazil this week reported that COVID -19 daily deaths reached a new high due to P1. According to Russian news agency Tass, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company’s COVID-19 clinical trial. The Company is interested to see what information, if any, might be gleaned from the trial regarding variants considering laboratory studies have indicated Brilacidin to have strong pan-coronavirus treatment potential, remaining unaffected by viral mutations.

https://www.biospace.com/article/releases/recruitment-and-enrollment-underway-at-eight-sites-for-innovation-pharma-s-phase-2-clinical-trial-of-brilacidin-for-covid-19/

NextCure upped to Buy from Hold by Truist

 Target $19

https://finviz.com/quote.ashx?t=NXTC

Second Sight Gets FDA Approval for Argus 2s Retinal Prosthesis

 Second Sight Medical Products (NASDAQ:EYES) a leading developer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, today announced U.S. Food and Drug Administration (FDA) has approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development.

In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.

“We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system,” said Matthew Pfeffer, acting CEO of Second Sight.

A decision on when or if to begin production of the newly approved hardware is pending completion of Second Sight’s planned business combination with Pixium Vision, which currently is in progress. Should the business combination be completed, the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development.

https://www.biospace.com/article/releases/second-sight-medical-products-inc-receives-fda-approval-for-the-argus-2s-retinal-prosthesis-system/

Chardan Upgrades Seres Therapeutics to Buy From Neutral,

 

Adjusts Price Target to $30 From $27.50

https://www.marketscreener.com/quote/stock/SERES-THERAPEUTICS-INC-22619573/news/Seres-Therapeutics-nbsp-Chardan-Upgrades-Seres-Therapeutics-to-Buy-From-Neutral-Adjusts-Price-Tar-32615363/

Oxford study indicates AstraZeneca effective against Brazil variant

 

Preliminary data from a study conducted at the University of Oxford indicates that the COVID-19 vaccine developed by AstraZeneca PLC is effective against the P1, or Brazilian, variant, a source with knowledge of the study told Reuters on Friday.

The data indicates that the vaccine will not need to be modified in order to protect against the variant, which is believed to have originated in the Amazonian city of Manaus, said the source, who requested anonymity as the results have not yet been made public.

The source did not provide the exact efficacy of the vaccine against the variant. They said the full results of the study should be released soon, possibly in March.

Early results indicated the AstraZeneca vaccine was less effective against the South African variant, which is similar to P1. South Africa subsequently paused the use of the vaccine in the country.

The information comes as a small-sample study suggested the COVID-19 vaccine developed by China's Sinovac may not work effectively against the Brazilian variant.

Responding to a request for comment, Fiocruz, which sent the samples that formed the basis of the study, told Reuters it did not have any information on the study, as it was being led by AstraZeneca and the University of Oxford.

Representatives for AstraZeneca and the University of Oxford did not immediately respond to requests for comment.

Brazil is currently confronting a brutal and long-lasting second wave of the coronavirus, hitting a daily record of 1,910 deaths on Wednesday.

The P1 variant is among the factors that epidemiologists believe is contributing to a rise in cases and deaths, and there has been concern in the scientific community about the variant's resistance to vaccines.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Exclusive-Oxford-study-indicates-AstraZeneca-effective-against-Brazil-variant-source-says-32615424/