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Merck says experimental RSV-protected infants are being tested, paving the way in which for possible approval

enzo2go — Thu, 24 Oct 2024 20:51:47 +0000

Merck On Thursday it said experimental recording The vaccine, designed to guard infants against respiratory syncytial virus, showed positive leads to a mid- to late-stage trial, bringing the corporate one step closer to applying for approval of the vaccine.

The pharmaceutical giant could emerge as a brand new competitor available in the market for treatments against RSV, which results in this Thousands Deaths amongst older Americans and a whole lot of deaths amongst young children every year. Complications from the virus are essentially the most common reason behind hospitalization in newborns, making Merck's drug a priceless latest treatment option if approved.

According to a press release, Merck plans to debate the study data with regulators worldwide with the goal of constructing the treatment available to infants as early because the 2025 to 2026 RSV season.

The study examined the security and effectiveness of a single dose of the treatment clesrovimab in healthy premature and full-term infants entering their first RSV season. Merck presented the outcomes on the IDWeek medical conference in Los Angeles.

Merck said the treatment reduced RSV-related hospitalizations by greater than 84% and hospitalizations resulting from lower respiratory tract infections by 90% in comparison with a placebo in infants as young as five months old. Clesrovimab also reduced lower respiratory tract infections requiring medical attention by greater than 60% over five months in comparison with a placebo.

RSV is a standard reason behind Lower respiratory tract infections equivalent to pneumonia. The results were consistent at each five and 6 months of the study, Merck said.

The frequency of antagonistic and serious negative effects was similar between patients who received Merck's shot and those that took placebo within the study. The company added that there have been no treatment-related or RSV-related deaths within the study.

“These promising results, showing a lower incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in alleviating the ongoing RSV burden for infants and their families,” Dr. Octavio Ramilo, chairman of the Division of Infectious Diseases at St. Jude's Children's Research Hospital, said the Merck press release. Ramilo can be involved within the court proceedings as an investigator.

Merck's clesrovimab could potentially compete with an identical treatment Sanofi And AstraZeneca called Beyfortus, which was briefly supply across the country last RSV season resulting from unprecedented demand. Both are monoclonal antibodies that release antibodies directly into the bloodstream, providing immediate protection.

However, Merck's treatment will be given to infants no matter their weight, which the corporate says could provide more convenient dosing. Meanwhile, the beneficial dosage of Beyfortus relies on an infant's body weight.

A Sanofi spokesman said the dosage of Beyfortus was “carefully selected as part of our clinical development and reflects the correct dosage for each baby,” with two different dosages depending on whether or not they are kind of than five kilograms, or about 11 kilos weighs. The implementation of those two doses was “effectively managed by providers” through the last RSV season, the spokesperson added.

Sanofi expects the US market to have sufficient Beyfortus inventory through the current RSV season, which usually begins in the autumn and lasts through the spring.

Last 12 months, Pfizer has launched an RSV vaccine that’s given to expectant moms who can pass the protection on to their fetuses.

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Pfizer pronounces that its experimental drug for a plague that causes lack of appetite and weight in cancer patients shows positive test results

enzo2go — Sat, 14 Sep 2024 17:11:43 +0000

Pfizer's experimental drug for a common, life-threatening condition The drug causes appetite and weight reduction in cancer patients and has shown positive ends in a mid-stage study, the drugmaker said on Saturday.

Patients with the condition, called cancer cachexia, who took Pfizer's drug showed improvements in body weight, muscle mass, quality of life and physical function, in keeping with the drugmaker. The results could pave the way in which for the drug, a monoclonal antibody called ponsegromab, to be approved within the U.S. as the primary treatment specifically for cancer cachexia.

The disease affects about nine million people worldwide and 80 percent of affected cancer patients are expected to die inside a 12 months of diagnosis, in keeping with the corporate.

Patients with cancer cachexia don’t eat enough to satisfy their body's energy needs, leading to significant fat and muscle loss, leaving them weak, drained, and in some cases unable to perform day by day activities. Cancer cachexia is currently defined as a lack of 5% or more body weight within the last six months in cancer patients, together with symptoms comparable to fatigue, in keeping with the National Cancer Institute.

The disease's symptoms could affect the effectiveness of cancer treatments and contribute to lower survival rates, Pfizer said.

“We would see ponsegromab fit into the treatment of cancer patients and really address this unmet need in cachexia, improving their well-being and their ability to care for themselves. And we also hope that they tolerate the treatment better,” said Charlotte Allerton, head of discovery and early development at Pfizer, in an interview with CNBC.

Pfizer has not disclosed the estimated sales potential of the drug, which could potentially be approved for various uses.

The company presented the information on Saturday on the Congress of the European Society of Medical Oncology 2024a cancer research conference in Barcelona, Spain. The results were also published within the New England Journal of Medicine.

The second phase trial involved 187 individuals with non-small cell lung cancer, pancreatic cancer or colon cancer who had high levels of a key think about cachexia called growth differentiation factor 15, or GDF-15. Allerton said it’s a protein that binds to a particular receptor within the brain and affects appetite.

After 12 weeks, patients who took the best dose of ponsegromab – 400 milligrams – experienced a 5.6 percent weight gain in comparison with those that received a placebo. Patients who took a 200-milligram or 100-milligram dose of the drug experienced a weight gain of about 3.5 percent and a pair of percent, respectively, in comparison with the placebo group.

Allerton said a working group of experts defined a weight gain of greater than 5% as a “clinically meaningful difference in cancer patients with cachexia.” She added that the drug's effect on other health indicators, comparable to increased appetite and physical activity, “is what really gives us encouragement.”

Pfizer said it had not observed any significant uncomfortable side effects with the drug. Treatment-related uncomfortable side effects occurred in 8.9 percent of patients who took a placebo and seven.7 percent of patients who received Pfizer's drug, the corporate said.

The company said it’s discussing plans with regulators for the drug's late-stage development and goals to start trials in 2025 that might be used to file a regulatory application. Pfizer can be studying ponsegromab in a Phase 2 trial in patients with heart failure, who can also suffer from cachexia.

Pfizer's drug works by lowering GDF-15 levels, which Pfizer believes can increase appetite and help patients maintain and gain weight.

“Most of us have low levels of GDF-15 in our tissues when we are healthy. But in many of these chronic diseases, in this case cancer, we actually see an upregulation of GDF-15 levels,” Allerton said.

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Amgen foregoes experimental weight reduction pill and pushes ahead with injection

enzo2go — Fri, 03 May 2024 07:26:35 +0000

Amgen announced Thursday that it could stop development of its experimental weight-loss pill and as a substitute proceed development of its injectable drug and other anti-obesity products in development.

Amgen is one in every of several drugmakers vying to enter the red-hot weight-loss drug space dominated by Novo Nordisk And Eli Lilly, which some analysts say could possibly be price $100 billion by the tip of the last decade. But the corporate also has other ways to capture a part of the market.

“Given the profile we’ve seen [the oral drug]We will not follow any further developments. Instead, we are making differentiated investments in MariTide and a number of preclinical products in the obesity space,” Amgen Chief Scientific Officer Jay Bradner said during a conference call Thursday.

Amgen is developing an injectable anti-obesity drug called MariTide, which is in an ongoing mid-stage trial in obese or obese adults without diabetes. The company will release initial data from this study later this yr, and Bradner said Amgen is “very pleased” with the outcomes thus far.

The company said it’s working with regulators to plan a late-stage trial for the treatment. Amgen said Thursday that additionally it is planning a Phase 2 trial of the drug to treat diabetes.

Amgen shares rose greater than 10% in prolonged trading Thursday following the comment on MariTide.

Amgen can also be developing other weight management drugs.

The drugmaker's oral drug, called AMG-786, is the second weight-loss pill to be discontinued previously yr.

Pfizer scrapped a twice-daily version of its obesity pill danuglipron in December after patients in a mid-stage trial had difficulty tolerating the drug. The company is currently developing a once-daily version of this medication.

Investors are fully focused on Amgen's pipeline of experimental weight reduction treatments. Amgen hopes to make use of a distinct approach to face out from the crowded field of potential players.

The company's experimental injection helps people reduce weight otherwise than existing injectable medications. Similar to Novo Nordisk's Wegovy and Eli Lilly's Zepbound, a part of Amgen's treatment prompts a gut hormone receptor called GLP-1 to manage an individual's appetite.

But while Zepbound prompts a second hormone receptor called GIP, Amgen's drug blocks it. Wegovy doesn’t goal GIP, which like GLP-1 suppresses appetite, but might also improve the way in which the body breaks down sugar and fat.

According to some clinical trial data, Amgen's injectable treatment also appears to assist patients reduce their weight after they stop taking it. The drugmaker can also be testing that its drug ought to be taken once a month and even less often, which could provide more convenience than weekly medications available on the market.

Patients given the very best dose of Amgen's MariTide – 420 milligrams – every month lost a median of 14.5% of their body weight in only 12 weeks Data from the phase 1 study published in February within the journal Nature Metabolism.

Amgen's first quarter results

Also on Thursday, Amgen reported first-quarter sales and adjusted earnings that beat Wall Street expectations, thanks partly to products from recently acquired Horizon Therapeutics.

Here's what Amgen reported for the primary quarter in comparison with Wall Street's expectations, based on an LSEG analyst survey:

Earnings per share: $3.96 versus expected $3.87
Revenue: $7.45 billion versus expected $7.44 billion

Amgen posted a net lack of $113 million, or 21 cents per share. In comparison, net income within the year-ago period was $2.84 billion, or $5.28 per share.

Excluding certain items, the corporate reported profit of $3.96 per share.

Amgen posted first-quarter revenue of $7.45 billion, up 22% from the identical period last yr.

This includes $914 million from Horizon Therapeutics products, including Tepezza for the treatment of thyroid eye disease.

Excluding Horizon Therapeutics' drugs, Amgen said its product sales rose 6% in comparison with the identical period last yr. Ten products achieved double-digit volume growth in the primary quarter, including the cardiovascular drug Repatha, the severe asthma treatment Tezspire and Blincyto, a drug used to treat a certain blood cancer.

Amgen also adjusted its forecast for the total yr barely upwards from its low point on Thursday.

The company expects revenue of $32.5 billion to $33.8 billion in 2024. That compares with a previous forecast of $32.4 billion to $33.8 billion.

Amgen expects full-year adjusted earnings of $19 to $20.20 per share. This compares to previous guidance of $18.90 to $20.30 per share.

Analysts surveyed by LSEG expect full-year revenue of $32.95 billion and adjusted earnings of $19.48 per share.

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