Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new interim data from the Phase 2a trial (NCT04003103) in adults evaluating the safety, tolerability and pharmacokinetics (PK) of the once-monthly oral islatravir tablet -- the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) -- for pre-exposure prophylaxis (PrEP). Interim findings demonstrate that once-monthly oral islatravir achieved the pre-specified efficacy PK threshold for PrEP at both of the two doses studied (60 mg and 120 mg). In the interim analysis using blinded data, both monthly doses of islatravir were found to have an acceptable tolerability profile. These data are shared as a late-breaking oral presentation during the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021) and featured in the official press conference of HIVR4P 2021.
Tuesday, January 26, 2021
CFO: J&J to release Covid vaccine data ‘soon’
J&J is expected to release data from its phase three trial testing its Covid-19 vaccine as early as this week.
U.S. officials and Wall Street analysts are eagerly anticipating the federal authorization of J&J’s vaccine, which could happen as early as next month. Unlike Pfizer’s and Moderna’s authorized vaccines, which require two doses given about three to four weeks apart, J&J’s requires only one dose. That means patients will not have to come back for another dose, simplifying logistics for health-care providers.
J&J Chief Financial Officer Joseph Wolk told CNBC on Tuesday the company expects the phase three trial data to be “robust.” He said it’s possible there may be differences in results for people tested in places like South Africa, where there is a new, highly contagious strain of the virus.
Moderna said Monday it is working on a booster shot to guard against the strain found in South Africa after it found its current vaccine appeared to be less effective.
“It’s going to be very inclusive in terms of having certain ethnicities [such as] Blacks, Hispanics and the elderly,” Wolk said on “Squawk Box.” “Because it’s so diverse because of the geographic representation that could provide a lot of insights.”
https://www.cnbc.com/2021/01/26/johnson-johnson-jnj-earnings-q4-2020.html
FDA accepts Vertex bid to expand CF med treatment to children 6-11
-FDA grants Priority Review of the application and sets a PDUFA target action date of June 8, 2021-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) to expand the use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 8, 2021. The submission was supported by data from a global Phase 3 study of TRIKAFTA in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation.
https://finance.yahoo.com/news/vertex-announces-u-fda-acceptance-133000339.html
Vir Phase 1 Data: Hepatitis B Surface Antigen Declines
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced initial topline data from its ongoing trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.
VIR-3434 is an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a T cell vaccine, in this case, against HBV. The XX2 vaccinal mutation, which has the potential to transform standard antibodies into T cell vaccines, has also been incorporated into one of Vir’s investigational COVID-19 monoclonal antibodies, VIR-7832, which is currently planned to enter a Phase 1b/2a trial this quarter. Vir has licensed exclusive rights to the XX2 mutation for use in infectious diseases.
“The need for a functional cure for the nearly 300 million people living with chronic HBV is paramount. Lowering HBsAg may help unlock a patient’s immune system, allowing it to provide the immune control necessary to achieve a functional cure,” said Kosh Agarwal, M.D., lead study investigator and consultant hepatologist and transplant physician at the Institute of Liver Studies, King’s College Hospital NHS Foundation Trust in London. “These early, first-in-patient results are exciting because they demonstrate that even at a very low dose, VIR-3434 is able to markedly lower HBsAg.”
https://finance.yahoo.com/news/initial-data-ongoing-phase-1-130000526.html
Edesa to Study Drug Candidate as Covid Rescue Therapy
Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that physicians involved in the company's ARDS study identified a number of COVID-19 patients who they believed could benefit from the experimental treatment, but were too ill to be considered for the main study. "This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.
Edesa's sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. The sub-study does not impact the design or results of Edesa's ongoing international Phase 2/3 study.
EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.
Edesa's Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the United States and Colombia. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.
https://finance.yahoo.com/news/edesa-biotech-study-investigational-drug-123000275.html
EU to monitor vaccine exports, but says it's not a ban
The European Commission will finalise a proposal by the end of the week to require pharmaceutical firms to register their vaccine exports from the European Union, while insisting it had no plans to impose an export ban.
EU countries learnt late last week that deliveries of the vaccine from AstraZeneca, which is expected to be approved on Friday, would be some 60% lower in the first quarter than initially indicated.
There have also been reduced deliveries of a vaccine jointly produced by Pfizer and BioNTech.
The European Commission, which has ordered hundreds of millions of doses of both vaccines, said on Tuesday it would have a proposal ready by the end of the week on vaccine exports, insisting it was merely to increase transparency.
“It’s worth noting we are not planning to impose export bans or export restrictions,” EU trade commissioner Valdis Dombrovskis told a news conference.
The bloc did require exports of protective equipment, including masks, to be authorised by individual EU countries at the start of the pandemic.
The European Union can already monitor exports via customs data, but wants clearer data as it seeks to hold pharmaceutical companies to their contracts.
“This is based on the idea that the European Commission has spent quite a lot of funds on the development of these production capacities to make sure there are sufficient doses available for the European Union and beyond,” a spokesman said.
Under EU contracts with COVID-19 vaccine makers, the EU has given up-front payments to secure doses in advance and boost firms’ production capacity.
Pharmaceutical companies are usually required to deliver ordered doses under quarterly schedules.
Practical details of the registration scheme were still to be worked out, he said.
The EU executive is set to hold a second round of crisis talks with AstraZeneca on Wednesday.
Biden to order fed online insurance marketplace to reopen
U.S. President Joe Biden plans to order the nation’s online insurance marketplace, healthcare.gov, to reopen for at least a few months to offer Americans a way to buy health insurance amid the COVID-19 pandemic, the Washington Post reported on Tuesday, citing several unnamed sources familiar with the plan.
The order to reopen the federal exchange offering health plans under the Affordable Care Act could come as soon as Thursday, the Post reported.