Lexicon up on positive early-stage data on neuropathic pain candidate LX9211

Lexicon Pharmaceuticals (LXRX +4%) is up on below-average volume on the heels of positive results from a Phase 1 multiple ascending-dose clinical trial evaluating neuropathic pain candidate LX9211 in healthy volunteers.

LX9211 demonstrated a favorable safety profile and pharmacokinetic activity supportive of once-daily dosing. The most common adverse events were headache and dizziness.

Small molecule LX9211 inhibits an enzyme called adaptor-associated protein kinase 1 (AAK1). The company acquired exclusive rights from development partner Bristol-Myers Squibb two years ago.

Development is ongoing.

https://seekingalpha.com/news/3524072-lexicon-up-4-on-positive-early-stage-data-on-neuropathic-pain-candidate-lx9211

FDA OKs new MRSA test from Roche

The FDA approves Roche’s (OTCQX:RHHBY -0.1%) cobas vivoDx MRSA diagnostic test to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization in nasal swab samples.

Results from the bioluminescence assay are generated in as little as five hours.

https://seekingalpha.com/news/3524088-fda-oks-new-mrsa-test-from-roche

Biogen’s aducanumab showed mixed results in Alzheimer’s studies

Results from two Phase 3 clinical trials, EMERGE and ENGAGE, evaluating Biogen’s (BIIB -2.9%) aducanumab in patients with early Alzheimer’s disease (AD) produced different outcomes. The data were presented at the Clinical Trials on Alzheimer’s Disease Conference in San Diego.

In EMERGE, the high dose arm met the primary endpoint of the change from baseline in CDR-SB score at week 78 compared to placebo (p=0.0101) and well as the secondary endpoints of ADAS-Cog 13 and ADCS-ADL-MCI at week 78. The other secondary endpoint, MMSE score, was not met in the larger dataset analysis but did based on the final dataset (p=0.0493). The low dose arm missed all endpoints.

In ENGAGE, both the low dose and high dose arms failed to achieve the primary and all secondary endpoints in either dataset.

The company plans to file a U.S. application based on the totality of the data.

https://seekingalpha.com/news/3524067-biogens-aducanumab-showed-mixed-results-in-alzheimers-studies

Cerner ramps up cybersecurity efforts with new partnership: 3 things to know

Cerner is teaming up with Cybereason, a cyber defense platform developer, to help healthcare providers address cybersecurity vulnerabilities and digital threats to their organizations, according to a Dec. 4 news release.

Three things to know:

1. Through the partnership, Cybereason will integrate its platform with Cerner’s software to help the EHR vendor’s clients streamline their respective cybersecurity infrastructures.

2. Cerner and Cybereason also plan to create a go-to-market strategy to provide remediation efforts for incidents detected through Cerner’s cyber consulting advisory services.

3. Cerner and Cybereason’s collaboration aims to address growing IT security risks, which have left healthcare organizations tasked with better securing their information systems, devices and data.

“Today our clients deliver care in a connected and digital way, a revolution that has contributed to safer and more efficient care,” said Jay Saviano, senior director of security solutions at Cerner, according to the news release. “With these technological advancements, it’s essential that every health system have robust digital security strategies.”

https://www.beckershospitalreview.com/ehrs/cerner-ramps-up-cybersecurity-efforts-with-new-partnership-3-things-to-know.html

Warren bill would block $40B+ companies making acquisitions: 5 things to know

A Senate anti-monopoly bill is in the works that could transform the health system landscape, reviewing past megamergers and banning them entirely for companies with revenue over $40 billion, Bloomberg reports.

Democratic presidential candidate Sen. Elizabeth Warren, D-Mass., is drafting the proposal, according to the report. Here are five quick takeaways for healthcare leaders, based on the Bloomberg review of the draft bill:

1. Mergers that involve a company with annual revenues of $40 billion or more will be banned.

2. Mergers that involve companies with combined sales over $15 billion will be banned.

3. Some exceptions to this ban will include companies at risk of bankruptcy.

4. The legislation would also consider the effect a transaction would have on entrepreneurs, innovation, privacy and workers, banning, for example, noncompete and no-poaching agreements.

5. Bloomberg writes that the law will likely face significant hurdles in Congress.

https://www.beckershospitalreview.com/hospital-management-administration/warren-legislation-would-block-40b-companies-from-making-acquisitions-5-things-to-know.html

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More Evidence That Aspirin Can Stave Off Death

Taking aspirin as infrequently as 1 to 3 times a month reduced the risk of all-cause and cancer-related mortality in older adults in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial compared to no aspirin use, a post-hoc analysis of 146,152 individuals in the trial indicated.

Moreover, more frequent, weekly use of aspirin significantly reduced the risk of mortality from both gastrointestinal and colorectal cancer and it reduced all mortality endpoints regardless of body mass index (BMI), Holli Loomans-Kropp, PhD, MPH, National Cancer Institute, Rockville, Maryland, and colleagues reported in JAMA Network Open.

The analysis was based on participants’ self-reports of aspirin use in the previous year, collected at enrollment.

At a median follow-up of 12.5 years (range 8.7-16.4 years), the risk of all-cause mortality was reduced by 16% (HR 0.84, 95% CI 0.80-0.88, P<0.001) among those who took aspirin 1 to 3 times a month versus none.

Taking aspirin once or twice weekly reduced the same endpoint (HR 0.86, 95% CI 0.81-0.90, P<0.001). Similar risk reduction for all-cause was also seen when aspirin was taken 3 or more times per week (HR 0.81, 95% CI 0.80-0.83, P<0.001).

Cancer mortality was also reduced with aspirin use 1 to 3 times per month (HR 0.87, 95% CI 0.81-0.94, P<0.001); more frequent use was also associated with reduced cancer mortality though the magnitude did not increase markedly (HR 0.85 for use 3 times or more per week, 95% CI 0.81-0.88, P<0.001).

Risk reductions were seen as well with frequent aspirin use for gastrointestinal cancer mortality (HR 0.75, 95% CI 0.66-0.84, P<0.001) and colorectal cancer mortality (HR 0.71, 95% CI 0.76-0.89, P<0.001).

When participants were stratified by baseline BMI, every mortality endpoint was also significantly reduced with aspirin use irrespective of weight status, and with no suggestion that the apparent protective effect was diminished for overweight/obese individuals.

“These findings suggest that prophylactic aspirin use may reduce risk of mortality among older individuals,” the authors concluded.

The PLCO Cancer Screening Trial randomized participants ages 55-74 to cancer screening or to a control arm at 10 centers in the U.S. This particular analysis included those participants who were 65 or older at baseline or survived to age 65 during follow-up. Mean participant age at baseline was 66.3 and slightly over half were women.

Loomans-Kropp and colleagues pointed out that evidence regarding the prophylactic benefit of aspirin in older adults has been mixed.

For example, the Aspirin in Reducing Events in the Elderly (ASPREE) study found that during 4.7 years of follow-up, adults from ages 65 to 70 years who took 100 mg of aspirin a day were at increased risk for all-cause mortality compared to placebo controls. However, this study contradicted many others that supported a survival benefit with aspirin. Loomans-Kropp and colleagues thus wanted to revisit the question and also to explore whether aspirin might be less protective among individuals who were overweight or obese.

The U.S. Preventive Services Task Force currently recommends low-dose aspirin for the prevention of both cardiovascular disease and colorectal cancer among individuals from ages 50 to 59 at average risk for cardiovascular disease, although they suggest treatment should be individualized for those from ages 60 to 69. The USPSTF made no recommendations for aspirin use in individuals 70 years of age and older, citing insufficient evidence.

Loomans-Kropp had no conflicts of interest to disclose.

• Primary Source

  JAMA Network Open

  Source Reference: Loomans-Kropp, H, et al “Association of aspirin use with mortality risk among older adult participants in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial” JAMA Network Open 2019; DOI: 10.1001/jamanetworkopen.2019.16729.

https://www.medpagetoday.com/primarycare/generalprimarycare/83689

Sight Diagnostics’ finger prick blood tester wins FDA clearance

The dream of a comfortable, tabletop blood testing device, one needing only a few drops taken from a finger and a handful of minutes, has now arrived in the U.S.—and this time carrying an official FDA clearance.

Sight Diagnostics received a 510(k) green light from the agency for its OLO analyzer, allowing it to provide lab-grade results for the common complete blood count test in hospitals, clinics and elsewhere.

The compact device uses digital microscopes to visually tally the number of red blood cells, white blood cells and platelets found in a sample to provide physicians with a quick overview of a patient’s general health. The panel is included in over 90% of baseline blood tests.

“The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” said Carlo Brugnara, director of the hematology lab at Boston’s Children’s Hospital, where U.S. clinical trials of the OLO device were conducted in part.

The OLO has been commercially available in Europe and other international markets since it obtained a CE mark in July 2018. Currently, it’s being evaluated by Oxford University Hospital Trust and will also form the base of a pilot blood testing program with the U.K. pharmacy chain Superdrug, according to Sight. The company also said it is working to establish partnerships in Africa, Asia and South America.

“In rarer cases––involving acute leukemia, for instance––a CBC can make the difference between life and death,” added Brugnara, who also serves as professor of pathology at Harvard Medical School.

Going forward, Sight plans to pursue an FDA waiver from CLIA laboratory regulations to certify OLO’s use in smaller U.S. practices and pharmacies.

“The years our R&D team spent solving complex engineering and design challenges have positioned us well to expand our offering in the future,” the Israeli startup’s chief technology officer, Sarah Levy, said in a statement.

“Our end-goal is to offer diagnostics for any disease with visible signatures in the bloodstream,” Levy said. “We are confident Sight can continue to improve patient outcomes through new, faster, less costly and more convenient testing.”

The OLO device and its artificial intelligence-based technology got its start screening tens of thousands of blood samples for signs of malaria using digital fluorescent microscopy. The company’s algorithms draw from nearly half a petabyte of blood image data collected over five years of clinical work.

https://www.fiercebiotech.com/medtech/sight-diagnostics-finger-prick-blood-tester-wins-fda-clearance