Drug Discovery and Development Archives - Page 126 of 158

Pfizer/BioNTech and Moderna vaccines appear to have a durable immune response

[Photo by Daniel Schludi on Unsplash]

A new study shows that the Pfizer and Moderna COVID-19 vaccines create an immune response that may protect recipients for years.

The study, published in Nature, revealed that those who received the two-dose mRNA vaccines developed by Pfizer/BioNTech and Moderna could provide immunity for years or even a lifetime in those who were infected with COVID-19 and vaccinated later. However, it remains unclear if vaccination alone has the same long-lasting effect for those who were not infected with the virus beforehand.

Washington University (St. Louis) immunologist Dr. Ali Ellebedy and colleagues conducted the study, finding that those who survived COVID-19 retained immune cells that recognized the virus in the bone marrow for at least eight months. Another team’s study showed that those “memory B cells” continue to mature and get stronger for at least o…

Lilly’s tirzepatide bests semaglutide in type 2 diabetes trial

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June.

Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.

A JAMA opinion article recently posited that semaglutide could lead to a ‘new dawn’ for obesity treatment.

The Lilly trial randomly assigned patients to receive tirzepatide at doses of 5 mg, 10 mg, or 15 mg or a 1-mg dose of semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist. Conversely, tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

In the 40-week SURPASS-2 trial, i…

HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoc…

Roche wins EUA for intravenous tocilizumab in treating COVID-19

Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19.

Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Actemra/RoActemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief, Roche said in a news release.

According to the release, Roche garnered authorization based on results from four randomized, controlled studies eva…

AGTC announces data from ongoing Phase 1/2 trial

Applied Genetic Technologies Corp. (NSDQ:AGTC) has announced 12-month data from a Phase 1/2 trial involving achromatopsia, an inherited retinal condition affecting roughly 27,000 people in the U.S. and EU. Most people with achromatopsia are legally blind.

AGTC is focusing on two gene mutations linked to the disorder known as A3 and B3. The former accounts for roughly half of the cases of achromatopsia while B3 is implicated in about one-quarter.

The company said the ACHM B3 drug candidate shows promising signs of biologic activity based on two visual function measurements. The company acknowledged that there was presently no consistent efficacy signal of activity for ACHM A3, but that it saw encouraging patient anecdotes in the A3 cohort.

Higher dose levels in the trials were correlated with higher response rates.

“Based on the data presented today, an important differences in our construct and clinical trial design, we are confident in our ach…

COVID-19 vaccinations continue to decline in the U.S.

[Photo by Daniel Schludi on Unsplash]

The pace of COVID-19 vaccination in the U.S. continues to fall. Today, the U.S. administered about 600,000 COVID-19 vaccine doses, which is far fewer than two months ago.

At the mid-April peak, healthcare workers administered more than 3 million COVID-19 vaccine doses. The pace of vaccination fell steadily from that time to early June before stabilizing at around 1 million doses per day.

Complicating matters is the spread of the Delta variant (B.1.617.2), which ravaged India. The variant is now dominant in the U.K. and Europe, threatening to undermine the return to normalcy there.

According to a preprint study, the Delta variant could become dominant in the U.S. within a matter of weeks. Indeed, the variant already is the cause of almost half of COVID-19 infections in some Midwest and mountain states, said CDC Director Dr. Rochelle Walensky in a briefing on …

DNA Script launches a benchtop DNA printer

DNA Script announced the commercial launch of its Syntax platform with the Syntax system, a benchtop nucleic acid printer.

South San Francisco, Calif.-based DNA Script designed its Syntax system, a fully integrated, automated printer powered by enzymatic DNA synthesis (EDS) technology, to synthesize 96 DNA oligos in parallel, comprised of up to 60 nucleotides in length and delivers them ready for use in molecular biology and genomics workflows without the need for additional handling, according to a news release.

The system includes the benchtop DNA printer, reagent and consumable kits, along with management software. It requires less than 15 minutes of setup and synthesises 20mers in about six hours for same-day results, plus up to 60mers in about 13 hours to be efficiently run overnight.

Once synthesis completes, the Syntax printer purifies, quantifies and normalizes the oligos for seamless input into the next step of the research workflow. The softwar…

Lilly pushing for accelerated FDA approval of Alzheimer’s drug donanemab

Eli Lilly (NYSE:LLY) has received breakthrough therapy designation from FDA for the investigational antibody donanemab for Alzheimer’s disease.

The company plans to file a biologics license application for the drug under the accelerated approval pathway later this year.

Like Biogen’s (NSDQ:BIIB) recently approved aducanumab, donanemab is a monoclonal antibody clearing sticky amyloid plaques. Donanemab clears a modified form of beta-amyloid known as N3pG.

The FDA’s decision to grant donanemab accelerated approval underscores the regulator’s support for the so-called “amyloid hypothesis,” which has divided researchers for decades.

In a Phase 2 study known as TRAILBLAZER-ALZ published in NEJM, donanemab recipients had a better composite score for cognitive function than placebo recipients after 76 weeks of treatment. The study authors, however, included that more substantial clinical data are needed to assess its safety and efficacy.

The compa…

No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …

FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.

The conditions appear to be more common in males.

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care.

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

RedHill Biopharma announces positive data for oral COVID-19 drug

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.

The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study, which involved 40 patients in the U.S.

The experimental drug inhibits sphingosine kinase-2 (SK2), an enzyme that plays a role in inflammation and replication of some viruses. Opaganib thus has dual antiviral and anti-inflammatory modes of action.

A total of 50% of opaganib recipients could breathe without ventilator support within 14 days of treatment compared to 22% of people in the placebo group.

Some 86.4% of patients receiving opaganib were able to leave the hospital within 14 days compared with 55.6% of placebo recipients.

The study anticipates that th…