GSK’s daprodustat will have to face FDA advisory committee

 GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year.

Daprodustat is vying to become the first drug in the HIF-PHI inhibitor class to reach the US market, after the FDA rejected two others – FibroGen/AstraZeneca’s roxadustat and Akebia’s vadadustat – mainly on the grounds that the safety data submitted wasn’t strong enough to allow approval.

GSK may have been hoping to get through the review for daprodustat without the FDA calling on its expert advisors, but it will now have to make the case for the safety and efficacy of its drug at the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) set for 26 October.

Daprodustat has been filed with the FDA on the strength of the ASCEND phase 3 trials programme, which included five trials in CKD patients – including those needing dialysis – and showed that the drug offered an oral alternative to injectable erythropoietin stimulating agents (ESAs) for anaemia, without sacrificing efficacy.

HIF-PHI drugs activate a red blood cell-generating response that occurs naturally when reduced oxygen levels are detected in the blood, and work in a different way to ESAs like epoetin alfa and darbepoetin alfa, which stimulate the production of more blood cells in the bone marrow.

Along with the convenience of oral dosing, HIF-PH inhibitors could also avoid some of the side effects linked to ESAs, including a higher risk of blood clots and tumours, and don’t need to be refrigerated during storage.

However, the FDA wasn’t convinced about the cardiovascular safety of roxadustat and asked for another clinical trial to bolster the data for the drug, although it was subsequently approved in the EU. Meanwhile, it concluded vadadustat did not have a “favourable” benefit-to-risk balance.

In daprodustat’s favour is that it has already been approved by the regulatory authority in Japan, where it is marketed as Duvroq, and has a comprehensive clinical trials programme that showed it was no worse than ESAs when it came to major adverse cardiovascular events (MACE) in both non-dialysis and dialysis patients.

The safety data has one element, however, that might be expected to stimulate discussion at the advisory committee meeting. In the first 28 days after treatment started, GSK’s drug was associated with a MACE rate of around 14%, versus 10% for ESAs, although there was no significant difference in the rate of blood clots.

GSK said it is “committed to working closely with the US FDA to bring daprodustat to appropriate patients with anaemia of CKD.” The company has previously set a peak sales target of £500 million to £1 billion ($575 million to $1.15 billion) for the drug.

https://pharmaphorum.com/news/gsks-daprodustat-will-face-fda-advisory-committee/

BioVie: Topline Results of Biomarker and Imaging Trial for Alzheimer's Treatment

 

• Vast majority of patients saw significant improvements in the Global Rating of Change (overall impression of patient’s daily abilities) with NE3107 treatment (p<0.0001 to p<0.05).
• NE3107 is associated with significant improvements in cognition as evidenced by the ADAS-Cog12 scale. 82% of 17 patients with MMSE >=20 experienced a 2.6 point decrease in ADAS-Cog12 (p=0.0046).
• Reductions in TNFa (considered to be an initial factor driving inflammation) after NE3107 treatment are significantly correlated with improvement in cognition.
• NE3107 treatment associated with trending improvements in ratio of p-tau:Ab. 60% of 10 patients with MMSE >=20 improved 0.002 in the ratio of p-tau / Ab (p=0.055).
• Early analyses of imaging data suggest fundamental biological improvements in blood flow and reduced oxidative stress that are consistent with the mechanism for NE3107 and are unlikely to be accounted for by placebo effect.
• No drug-related adverse events (AEs) were reported.
• Detailed results will be presented at the CTAD 2022 Annual Conference.

https://www.biospace.com/article/releases/biovie-and-dr-sheldon-jordan-jointly-announce-topline-results-from-an-investigator-sponsored-exploratory-biomarker-and-imaging-trial-of-ne3107-for-the-treatment-of-alzheimer-s-disease/

Glaukos Announces Positive Topline Outcomes for Both Phase 3 Pivotal Trials

 Phase 3 Pivotal Trials Met Pre-Specified Primary Efficacy Endpoints for Both Doses of iDose TR (Fast- and Slow-Release Models), Supporting Anticipated Upcoming NDA Submission

93% of Slow-Release iDose TR Subjects Remained Well-Controlled on the Same or Fewer IOP-Lowering Topical Medications at 12 Months After a Single Administration of iDose TR, Including 81% Completely Free of IOP-Lowering Medications

iDose TR Demonstrated Excellent Tolerability and a Favorable Safety Profile Through 12 Months

https://finance.yahoo.com/news/glaukos-announces-positive-topline-outcomes-110000805.html

Walmart, UnitedHealth to offer joint program for preventive healthcare for seniors

 Walmart and health insurer UnitedHealth Group are planning to team up to provide preventive care for people aged 65 and up and virtual health-care services for all age groups, the companies said on Wednesday.

The 10-year partnership represents Walmart's latest push into health care and could help the retail giant better compete with CVS Health and Walgreens Boots Alliance.

Walgreens last October invested $5.2 billion in primary-care provider VillageMD, which has more than 200 locations across 15 markets.

Walmart's effort with UnitedHealth will target common ailments among aging Americans such as heart disease and diabetes.

When it gets under way in January, the collaboration is expected to initially offer seniors healthcare at 15 Walmart Health locations in Georgia and Florida. The focus will be on value-based healthcare, a model in which hospitals and doctors' offices are reimbursed for the care they provide through multiple Medicare Advantage plans.

Medicare Advantage is a Medicare-approved plan from a private company and is an alternative to Original Medicare, the federal government's health insurance plan for seniors.

The collaboration will initially exclude coverage for members under Original Medicare.

Unlike traditional fee-for-service models, in which health insurers pay doctors a fee for each service provided, value-based health-care payments are tied to a patient's outcome and health. The model typically provides preventive measures including dietary guides, cancer screenings and frequent doctor visits.

"We expect that through this partnership, we would grow to serve hundreds of thousands of seniors," Dan Schumacher, UnitedHealth Group chief strategy and growth officer, said.

"Our goal is to make (healthcare) accessible and keep it affordable using these solutions, particularly in these medically underserved communities," Dr. Cheryl Pegus, executive vice president of Health and Wellness at Walmart, said.

https://finance.yahoo.com/news/walmart-unitedhealth-offer-joint-program-103334047.html

Seres Submits Application for Work on C. difficile Therapy

 – Investigational therapeutic SER-109 has the potential to become the first-ever FDA-approved oral microbiome therapeutic –

– Anticipated product launch in the first half of 2023 –

https://finance.yahoo.com/news/seres-therapeutics-announces-completion-rolling-110000716.html

As China's economy slows, one industry is seeing record profits: Covid testing

 China's zero-Covid strategy of endless testing and lockdowns has hammered its economy and taken a toll on company profits, but it has delivered a windfall for test makers.

Twelve of China's top Covid testing firms have recently posted huge increases in both revenues and net profits for the first half of this year.

Andon Health, which supplies Covid test kits both at home and abroad, reported that its net profit skyrocketed by 27,728% in the first six months of 2022, reaching 15.24 billion yuan ($2.2 billion). It was the biggest increase recorded by any listed company in mainland China.

Meanwhile, its revenue surged 3,989%.

The company benefits not only from China's aggressive testing campaign at home, but also from huge demand in the United States, as its iHealth Lab had recently won US government contracts for supplying antigen rapid tests.

Assure Tech, a Hangzhou-based diagnostic firm, also posted a 1,324% increase in net income because of strong demand in the global Covid testing market.

Other test makers recorded net profit increases from 55% and 376% for the first six months of the year.

Endless Covid testings, back-and-forth government-enforced lockdowns, and border restrictions have wreaked havoc on China's economy. GDP grew only 0.4% in the second quarter, the slowest pace in more than two years. Major investment banks have slashed their full-year growth forecasts for China to 3% or under, sharply lower than the 5.5% official target set by the government earlier this year.

Chinese companies have also suffered one of their worst earnings recessions on record. More than half of the 4,800 companies listed in Shanghai, Shenzhen, and Beijing posted a decline in net profit for the first half of the year — almost as bad as early 2020, when most companies posted their worst earnings season ever.

But the diagnostic firms are one of the biggest moneymakers during the pandemic, benefiting from enormous demand for testing as Beijing sticks with its zero-Covid policy that involves forced quarantines, mass mandatory testings, and snap lockdowns.

From the beginning of the pandemic through April 2022, 11.5 billion tests had been conducted in China, according to the government.

That figure may have significantly increased since then, as analysts from Soochow Securities recently estimated that 10.8 billion tests had been conducted in the three months from April to June.\The costs may be a big burden on the Chinese government's finances, which have already taken a hit from collapsing property sales. In May, officials in Beijing made it clear provincial and city governments had to bear the costs for regular Covid testing.

Assuming big Chinese cities that account for 30% of the population conduct Covid tests twice a week, the direct cost of testing may total 200 billion yuan ($30.1 billion) from May to the year's end, according to an estimate by Goldman Sachs earlier this year.

The number could rise further if the remaining 70% of the population is tested and costs of setting up testing sites and quarantine centers are taken into account, Goldman Sachs said.

https://www.cnn.com/2022/09/07/economy/china-covid-testing-firms-moneymakers-intl-hnk/index.html

Monte Rosa Shares Rise As FDA Announced Clearance To MYC-Driven Cancer Study

 The U.S. Food and Drug Administration (FDA) has announced clearance to Monte Rosa Therapeutics’ 

GLUE+ Free Alerts

 investigational new drug application (IND) for its drug candidate MRT-2359 in patients with MYC-driven solid tumors.

The Phase 1/2 clinical trial will evaluate MRT-2359 in patients with MYC-driven solid tumors, including lung cancer.

MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader (MGD).\Markus Warmuth, Chief executive officer, said, "The FDA's clearance of our first IND serves as a critical milestone for Monte Rosa and continues to validate our differentiated approach to protein degradation. Molecular glue degraders hold tremendous promise in tackling the universe of previously undruggable proteins and fostering a new generation of precision medicine therapeutics. After reporting compelling preclinical data, we are excited to advance MRT-2359 into a Phase 1/2 study for patients with MYC-driven solid tumors who otherwise have limited treatment options.”

The company is  planning to initiate patient dosing in the fourth quarter of 2022.

Monte Rosa Therapeutics is a biotechnology company developing a portfolio of novel molecular glue degrader (MGD) medicines. These medicines are designed to employ the body's natural mechanisms to selectively eliminate therapeutically relevant proteins.

https://www.benzinga.com/general/biotech/22/09/28760545/monte-rosa-shares-rise-as-fda-announced-clearance-to-myc-driven-cancer-study