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Friday, July 31, 2020

Botox injections may help lessen depression – study

Wrinkles — and depression — be gone.
Botox isn’t just used for smoothing signs of aging. The injection, which is derived from a bacterial toxin, also has a host of known medical uses including easing migraines, muscle spasms, excessive sweating and, according to a new study, potentially lessening depression.
“For years, clinicians have observed that Botox injected for cosmetic reasons seems to ease depression for their patients,” said lead author Ruben Abagyan in a press release for the study, published Thursday in the journal Scientific Reports.
Previously, it was believed this was due to a psychological side effect from Botox reducing the appearance of sadness, but Abagyan and his team found that the drug lessened depression even when it wasn’t used on the face.
“It’s been thought that easing severe frown lines in forehead region disrupts a feedback loop that reinforces negative emotions. But we’ve found here that the mechanism may be more complex, because it doesn’t really matter where the Botox is injected,” Abagyan, who is also a professor of pharmacy, said.
To determine this, researchers mined over 13 million reports in the Food and Drug Administration’s Adverse Effect Reporting System database to locate nearly 40,000 reports of Botox treatment in individuals who were not taking antidepressants. Botox recipients, compared to those who received different treatments for the same issue, reported depression significantly less, researchers found.
“This finding is exciting because it supports a new treatment to affect mood and fight depression, one of the common and dangerous mental illnesses — and it’s based on a very large body of statistical data, rather than limited-scale observations,” said FDA research fellow and study co-author Tigran Makunts.
More research is needed to confirm why Botox works as an antidepressant, but researchers currently hypothesize that either the injection interacts with mood-determining regions of the central nervous system or that it treats chronic conditions which were contributing to depression, thus indirectly relieving the depression by way of relieving the condition causing it.

Lifestyle, Policy Changes Could Make Big Dent in Dementia Burden

About 40% of dementia cases may be prevented or delayed by modifying 12 risk factors, researchers reported at the 2020 virtual Alzheimer’s Association International Conference (AAIC).
These 12 factors include three new items — excessive alcohol intake and head injury in mid-life, and exposure to air pollution in later life — that have been added to the Lancet Commission’s list of key modifiable risk factors for dementia, said Gill Livingston, MD, of University College London in England, and co-authors, during an online AAIC presentation.
The list, part of the commission’s report on dementia prevention, intervention, and care published simultaneously in The Lancet, expanded the number of potentially preventable causes of dementia in the commission’s 2017 report, laying out lifestyle changes and public health policies that may help reduce dementia cases.
“We’re very excited to be able to put together and generate evidence about prevention and care which are relevant to all health care professionals in primary and secondary care and public health,” Livingston told MedPage Today.
“We all have a part to play in reducing the number of people who develop dementia by tackling risks and in maximizing the health of people with dementia and their families,” she said. “We can make a huge difference to individuals, families, and nations.”
The report separated modifiable factors into early, mid-, and late-life prevention, with varying attributable risk:
  • Early life: poor education (7.1%)
  • Midlife: hearing loss (8.2%), traumatic brain injury (3.4%), hypertension (1.9%), excessive alcohol (0.8%), and obesity (0.7%)
  • Later life: smoking (5.2%), depression (3.9%), social isolation (3.5%), physical inactivity (1.6%), air pollution (2.3%), and diabetes (1.1%)
“Dementia and Alzheimer’s disease are multi-determined,” said co-author Lon Schneider, MD, of the University of Southern California in Los Angeles, who spoke about the challenges of dementia care during the presentation.
“We know a single new drug or antibody or even a combination, if successful, will have only limited impact, and is unlikely to exert therapeutic effects as great as our being able to prevent, delay, lower risk, and alter clinical course through multimodal interventions and care,” he said.
The authors also listed nine recommendations for policymakers and individuals to reduce dementia risk:
  • Aim for systolic blood pressure of 130 mm Hg or less from around age 40
  • Encourage hearing aids for hearing loss and reduce hearing loss by protecting ears from high noise levels
  • Reduce air pollution and second-hand tobacco smoke exposure
  • Prevent head injury, especially in high-risk occupations and transportation
  • Prevent alcohol misuse and excessive drinking
  • Stop smoking and support individuals to stop smoking
  • Provide all children with primary and secondary education
  • Lead an active life into midlife and possibly later life
  • Reduce obesity and diabetes

Pfizer Spinoff Cerevel Merges with Arya Sciences and Goes Public

July 31, 2020

Boston-based Cerevel Therapeutics, which spun out of Pfizer two years ago, entered into a business combination deal with Arya Sciences Acquisition Corp II, a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors. Once the deal is completed, Arya II will redomicile as a Delaware corporation and be renamed Cerevel Therapeutics Holdings, trading on the Nasdaq under the ticker symbol “CERE.”
Ayra II’s trust account held about $150 million. A group of investors has agreed to raise about $320 million at $10 per share through a common stock PIPE. The investors include Perceptive Advisors, an affiliate of Ayra II’s sponsor, Adage Capital Management, Ally Bridge Group, Boxer Capital, EcoR1 Capital, Federated Hermes Kaufmann Small Cap Fund, Fidelity Management & Research Company, Invus Public Equities, Novalis LifeSciences, RA Capital Management, funds managed by Rock Springs Capital, Sphera Healthcare, Surveyor Capital, funds and accounts managed by T. Rowe Price Associates, and existing Cerevel Therapeutics shareholders including Bain Capital and Pfizer.
The merged companies expect to receive net proceeds of about $445 million when the deal closes. It plans to continue under the Cerevel Therapeutics management team, lead by chair and chief executive officer Tony Coles.
“Cerevel is using novel approaches in its quest to bring new treatments to patients living with neuroscience diseases, and today we are bringing that same spirit of innovation to our plans for becoming a public company,” said Coles.
He went on to say, “Since our founding as a joint collaboration between Bain Capital and Pfizer, Cerevel has pushed the boundaries to tackle some of the most vexing questions in neuroscience, using science to target the specific receptor sub-types involved in causing these devastating diseases. Over the next 12 months, we expect to have initiated at least six clinical programs across multiple indications, including schizophrenia, anxiety, epilepsy, and Parkinson’s disease. Today’s announcement ensures that we have access to the capital we will need to advance our clinical programs through to several key milestones in our quest to bring these therapies to patients.”
BioPharma Dive notes that 41 biotechs have launched initial public offerings (IPOs) this year, which is a third more than occurred at this time in 2019. But Cerevel’s approach was a bit unusual, turning to Arya. SPACs raise funds with the plan to acquire or merge with another company, where the combined companies then take the place of the SPAC on a stock exchange.
According to BioPharma Dive, more than 50 SPACs have been formed this year and raised a record $21 billion for private company takeouts. These deals include electric truck manufacturer Nikola, sports gambling company DraftKings and Multiplan, a health services firm.
The funds that came out of the merger and PIPE will be used to advance several programs. These include:
• CVL-231, a positive allosteric modulator (PAM) that targets M4, the muscarinic acetylcholine 4 receptor subtype. It is currently in a Phase Ib trial for schizophrenia, with data expected in the second half of 2021.
• CVL-865 is a PAM that selectively targets the alpha-2/3/5 subunits of the GABAA receptor. The company hopes to launch a Phase II trial for drug-resistant focal onset epilepsy in the second half of 2020, with data announced in the second half of 2022. It also hopes to launch a Phase I proof-of-principle trial of the compound for acute anxiety in the second half of 2020, with data in the second half of 2021.
• Tavapadon, a selective dopamine D1/D5 partial agonist, which the company hopes to study in several Phase III trials for early- and late-stage Parkinson’s disease as a monotherapy and in combination with levodopa. The company initiated a Phase III program for the drug in January 2020, including two trials in early-stage Parkinson’s, one in late-stage Parkinson’s, and an open-label safety extension trial. The first readouts from the program are expected in the first half of 2023.

Alexion Ends Rare Kidney Disease Program Following Poor Data

In October 2019, Alexion Pharmaceuticals snapped up Achillon Pharmaceuticals and its oral small molecule Factor D inhibitor program for a rare kidney disease for $930 million in cash. This week, the company shuttered the program following disappointing clinical data.
In its quarterly financial report, Alexion announced it discontinued studies of ALXN2040 in C3 Glomerulopathy following disappointing interim data from two Phase II studies in this indication. C3 Glomerulopathy is a rare kidney disease caused by an excessive activation of the alternative complement pathway that leads to deposition of complement factor C3 in glomeruli, a cluster of blood vessels around the end of a kidney tubule, where waste products are filtered from the blood. Alexion said the interim data suggest that inhibition of Factor D is a promising potential target for treating the cause of C3G. However, the study showed that the clinical response with ALXN2040 was suboptimal, due to insufficient PK/PD response and incomplete inhibition of the alternative pathway.
As a result of those findings, Alexion said the development of ALXN2040 in C3G will be discontinued.
While the company is not going to further study ALXN2040 in this setting, the company noted that it could initiate a program in C3G with a more potent Factor D inhibitor, ALXN2050. The more potent ALXN2050 is currently in a Phase II study as a monotherapy treatment for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). PNH is a chronic and life-threatening ultra-rare blood disorder caused by the destruction of red blood cells. Additionally, Alexion said it plans to initiate a proof-of-concept trial of ALXN2050 in patients with various renal diseases in 2021.
When the deal was announced in October 2019, Alexion Chief Executive Officer Ludwig Hantson said, “inhibiting Factor D production addresses uncontrolled complement activation further upstream in the complement cascade, and importantly, leaves the rest of the complement system intact, which is critical in maintaining the body’s ability to fight infection.”
Earlier this year, Alexion snapped up Portola Pharmaceuticals and its blood disorder treatments in a $1.41 billion deal. Alexion said the acquisition of Portola will bolster its commercial portfolio and create long-term value for its shareholders. The deal brings Portola’s Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] under its umbrella. Andexxa, was approved by the U.S. Food and Drug Administration in 2018 and is currently the only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding. In addition to Andexxa, Portola also has Bevyxxa in its pipeline. Portola’s drug is the only anticoagulant approved for hospital and extended duration prophylaxis of 35 to 42 days of venous thromboembolism (VTE) in adult patients who have been hospitalized for an acute medical illness

Kids may play ‘important role’ in spreading COVID-19 – CDC

A new report from the Centers for Disease Control and Prevention (CDC) says children might play a bigger role than previously thought in the spread of COVID-19, raising new concerns about holding in-person classes this fall.
In a report published Friday, the CDC said more than 250 people — mostly children — tested positive for the coronavirus after attending an overnight summer camp in Georgia where masks weren’t required.
A total of 597 Georgia residents attended the summer camp in June. The camp imposed most but not all of the CDC’s guidelines to slow or prevent the spread of COVID-19.
Of the 344 test results that were available to the CDC, 260 — or 76 percent — were positive, indicating children might play an “important role” in transmitting the disease, according to the report.
The camp, which was not named in the report, required staff members to wear cloth masks but did not extend that requirement to campers. Windows and doors were not left open to increase ventilation in camp buildings, according to the CDC.
Large groups of kids sleeping in the same cabins, as well as singing and cheering, likely contributed to transmission, the report said.
“These findings demonstrate that SARS-CoV-2 spread efficiently in a youth-centric overnight setting, resulting in high attack rates among persons in all age groups, despite efforts by camp officials to implement most recommended strategies to prevent transmission,” the report reads.
About half of those who tested positive were between the ages of 6 and 10, while 44 percent were ages 11 to 17. Thirty-three percent were 18-21.
Georgia allowed overnight camps to operate beginning May 31. The camp cited in the study was open June 17-27.
All trainees, staff members and campers provided documentation of negative COVID-19 tests taken less than 12 days before arriving at camp, as required by an executive order signed by Gov. Brian Kemp (R), according to the report.
A teenage staff member left the camp on June 23 after experiencing chills. The staff member tested positive for COVID-19 the following day, and officials began sending campers home the same day.
According to test results, the COVID-19 attack rate was 44 percent, but higher for kids between the ages of 6 and 10 and highest for those who stayed at the camp longest, including staffers, who arrived a few days earlier for training.
Of the cases at the camp where symptom data is available, 26 percent had no symptoms. Among the 74 percent who reported symptoms, fever and headache were the most common.
“Settings, like multi-day, overnight summer camps, pose a unique challenge when it comes to preventing the spread of infectious diseases, considering the amount of time campers and staff members spend in close proximity,” the CDC said in a statement accompanying the report.
“Correct and consistent use of cloth masks, rigorous cleaning and sanitizing, social distancing, and frequent hand washing strategies, which are recommended in CDC’s recently released guidance to reopen America’s schools, are critical to prevent transmission of the virus in settings involving children and are our greatest tools to prevent COVID-19.”
Georgia is now experiencing a large COVID-19 outbreak, reporting more than 3,300 new cases a day.
The CDC recommends schools reopen in the fall, with proper safety cautions, including mask-wearing by students and staff and social distancing in classrooms.
Most children who get COVID-19 experience mild symptoms, like fever and cough, or no symptoms at all, a fact touted by the Trump administration as a reason to reopen classrooms.
The administration also argues that forgoing in-person instruction has adverse effects on student learning and health. Reopening schools also holds the added benefit of allowing parents to get back to work, providing Trump a much-needed boost to the economy.
Still, evidence is mixed about whether children are less likely to get infected when exposed to the virus. There is also not enough evidence to determine what role children play in spreading the virus to each other and to adults, a question that looms large over school openings as teachers, staff and others would be exposed to children for several hours a day.
But the CDC report released Friday indicates kids might play a greater role in spreading COVID-19, especially when safety precautions like mask-wearing are not followed.
“This investigation adds to the body of evidence demonstrating that children of all ages are susceptible to [COVID-19] and contrary to early reports, might play an important role in transmission,” the report reads.
“The multiple measures adopted by the camp were not sufficient to prevent an outbreak in the context of substantial community transmission.”

New Jersey COVID-19 numbers are setting off alarms, governor says

It doesn’t look like New Jersey will be moving to stage 3 of easing lockdown restrictions anytime soon.
Governor Phil Murphy points to the state’s transmission rate increasing to 1.35 at July 29 and its positivity rate of 2.15% for COVID-19 tests from July 27, in a post on Twitter.
These numbers are setting off alarms,” Murphy said. “The only way to silence these alarms is by taking this seriously. Wear a mask. Stop hosting house parties. Now.”
A transmission rate over 1.0 shows that each existing infection is causing more than one new infection.
The transmission rate was 0.81 when New Jersey moved to stage 1 of reopening and at 0.70 when it moved to stage 2.

U.S. doesn’t have capacity to return COVID-19 tests within 72 hours – Giroir

A U.S. health official said it is not currently possible to return COVID-19 diagnostic test results to Americans within 72 hours. “It is not a possible benchmark we can achieve today, given the demand and supply,” Dr. Brett Giroir, assistant secretary for health for the Department of Health and Human Services, said while testifying during a hearing on Friday with lawmakers. During the hearing, the National Institutes of Health said it will spend about $250 million to support development of new tests that the government agency says will help increase the “number, type, and availability of tests by millions per week.” The U.S. has conducted more than 54.6 million tests; however, there are still anecdotes about lagging wait times for test results.