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Tuesday, June 9, 2020

Many Can’t Access Addiction Treatment Or Support Due To Pandemic

Coronavirus is significantly disrupting essential treatment and support services for people suffering with substance abuse disorders, according to a new report released by the Addiction Policy Forum on Tuesday.
The report, supported by the National Institute on Drug Abuse (NIDA), surveyed more than 1,000 individuals with substance use disorders, plus an additional 533 people without a disorder across 46 states, and found that the pandemic is having a marked effect on people’s health and emotional wellbeing.
While the survey isn’t completely representative and more research is needed to get a complete picture, the initial findings do give a telling glimpse into how Covid-19 is impacting people with addiction.
“[The pandemic] is having a pretty profound impact. The social isolation, the loss of jobs and income, grief and loss of family members, combined with being disconnected from treatment and recovery support is creating a lot of distress,” said Jessica Hulsey, author and president of Addiction Policy Forum.
Results showed that a third of respondents reported a disruption in their treatment or support services, of which 14% can’t access the services or treatment they need. These services include in-person support, syringe and naloxone services, and medication assisted treatment like methadone.
Hulsey notes that people who experienced a disruption in care were emotionally worse off than those who were still able to get treatment and support.
“When you disrupt those [services] that becomes very problematic,” said Hulsey.
According to the Addiction Policy Forum report, 4% of people surveyed experienced an overdose since the pandemic began.
“It’s a number and feedback from our field that we need to take seriously,” said Hulsey, “We had 45 overdoses reported, 10 being fatal and there were also write-in comments about suicidal ideation and suicidal thoughts.”
In addition, there were also several mentions of relapse.
“My parent was doing well in recovery – seeing a therapist, going to AA meetings daily, and getting out and about to stay active. Being stuck inside and socially isolated resulted in a relapse. He is hard of hearing so has not been able to utilize telehealth and his therapist’s calendar has been booked up,” said one of the Addiction Policy Forum report respondents.
Anecdotally, experts have also noted a rise in relapses across the U.S.
“Yes, we are already starting to see an increase in relapses,” Dayry Hulkow, M.S., a primary therapist at Arete Recovery, a Delphi Behavioral Health Group facility, told Fox News.
“There’s some initial data coming out of the White House that suggests that there might be spikes in overdoses and relapses and we’re hearing from our stakeholder and practitioner friends on the ground that they’re seeing more overdoses, relapses and deaths by suicide during the pandemic,” added Hulsey.
Although, the increase is not that surprising since experts have warned that this could be an unintended consequence for people in recovery since the outset of the pandemic.
Experts explain that the conditions of the Covid-19 pandemic are ripe for relapse and overdose.
“Addiction is a chronic disease. It has more in common with diabetes or heart disease, so you need long-term support,” explains Hulsey, mentioning things like 12-step programs, counselling, diet and exercise.
“All of a sudden during the pandemic the resources and tools that people have built have become harder to access or they’ve disappeared altogether and that can create a crisis.”
Dr. Mark Calarco, American Addiction Centers national medical director for clinical diagnostics, added that stress, isolation and the lack of normal routines are also major triggers for relapse.
“Peoples normal routines have been impacted and it’s a significant issue,” he said.
“People who are in recovery need structure, they need contact with others who can support them. They need a routine. Now with Covid those things aren’t available. So people are at home, stressed and if there’s paraphernalia around that’s a temptation. Also they don’t have the reinforcement they need.”
This can be especially difficult when you’re in the early stages of recovery, but can be equally challenging even if you’ve been in recovery for a long time.
“I have been free of illicit drugs for 20 years. During the last month I have felt more at risk of relapse than I ever have,” said one of the report respondents.
While service providers have done their best to adapt to the current limitations – switching to virtual group meetings or telehealth counselling – experts say they aren’t enough.
“They’re good supplementals but they don’t take the place of face-to-face,” said Calarco.
“We need to make sure as the Covid-19 pandemic collides with the opioid epidemic and addiction that we are providing additional services to take better care of our patients,” said Hulsey.
Going forward, Hulsey thinks healthcare providers need to think creatively about how to accommodate patients and continue vital services. She suggested things like extra large meeting rooms or moving group meetings outside emphasising that protections need to be put in place for patients.
“We need to make sure we are providing a level of care that people need to meet them where they are, and figure out what works and what doesn’t for each patient, particularly with so many people are struggling with addition,” said Hulsey.
“If we’re seeing [… overdose] numbers start going in the wrong direction again, we need to act quickly to make sure we connect people to care immediately.”
https://www.forbes.com/sites/mishagajewski/2020/06/09/people-cant-access-addiction-treatment-or-support-because-of-the-pandemic-and-its-very-problematic-say-experts/#124a440342a4

Fauci says COVID-19 nightmare isn’t over yet

COVID-19 is Dr. Anthony Fauci’s “worst nightmare” and “it isn’t over yet,” the White House health adviser said in an interview with the BIO Digital virtual health-care conference.
His comments comes as Arizona re-activates hits hospital emergency plan for a second time in response to rising COVID-19 cases, about three weeks after the state lifted its stay-at-home order.
He emphasizes how quickly the virus spread. “In a period of four months, it has devastated the world.”
It differs from Ebola and HIV in that it has such a high degree of transmissibility and mortality.
Fauci said he’s “heartened” by the pharmaceutical industry’s response. More than 124 COVID-19 vaccines were under development as of June 2, according to the World Health Organization.
 “There’s going to be more than one winner in the vaccine field because we’re going to need vaccines for the entire world. Billions and billions of doses,” he said.
https://seekingalpha.com/news/3581743-fauci-says-covidminus-19-nightmare-isnt-over-yet

Identifying targets for COVID-19 vaccine using cancer immunotherapy tools

Cancer researchers at Children’s Hospital of Philadelphia (CHOP) have harnessed tools used for the development of cancer immunotherapies and adapted them to identify regions of the SARS-CoV-2 virus to target with a vaccine, employing the same approach used to elicit an immune response against cancer cells to stimulate an immune response against the virus. Using this strategy, the researchers believe a resulting vaccine would provide protection across the human population and drive a long-term immune response.
The strategy is described in Cell Reports Medicine.
“In many ways, behaves like a virus, so our team decided to use the tools we developed to identify unique aspects of childhood cancers that can be targeted with immunotherapies and apply those same tools to identify the right protein sequences to target in SARS-CoV-2,” said senior author John M. Maris, MD, a pediatric oncologist in CHOP’s Cancer Center and the Giulio D’Angio Professor of Pediatric Oncology at the Perelman School of Medicine at the University of Pennsylvania. “By adapting the computational tools developed and now refined by lead author Mark Yarmarkovich, Ph.D. in the Maris Lab, we can now prioritize viral targets based on their ability to stimulate a lasting immune response, predicted to be in the vast majority of the human population. We think our approach provides a roadmap for a vaccine that would be both safe and effective and could be produced at scale.”
The COVID-19 pandemic has led to an urgent need for the development of a safe and effective vaccine against SARS-CoV-2, the virus that causes the COVID-19 disease. An optimally designed vaccine maximizes a long-lasting , while minimizing , autoimmunity, or disease exacerbation.
To increase the likelihood that a vaccine is both safe and effective, the research team prioritized parameters in identifying regions of the virus to target. The researchers looked for regions that would stimulate a memory T-cell response that, when paired with the right B cells, would drive memory B cell formation and provide lasting immunity and do so across the majority of human genomes. They targeted regions of SARS-CoV-2 that are present across multiple related coronaviruses, as well as new mutations that increase infectivity, while also ensuring that those regions were as dissimilar as possible from sequences naturally occurring in humans to maximize safety.
The researchers propose a list of 65 peptide sequences that, when targeted, offer the greatest probability of providing population-scale immunity. As a next step, the team is testing various combinations of a dozen or so of these sequences in mouse models to assess their safety and effectiveness.
“With the third epidemic in the past two decades underway, all originating from the coronavirus family, these viruses will continue to threaten the and necessitate the need for prophylactic measures against future outbreaks,” said Dr. Yarmarkovich. “A subset of the sequences selected in our study are derived from viral regions that are very similar to other coronaviruses, and thus our approach, if successful, could lead to protection against not only SARS-CoV-2 but also other coronaviruses that might emerge in the future.”
More information: Mark Yarmarkovich et al, Identification of SARS-CoV-2 Vaccine Epitopes Predicted to Induce Long-term Population-Scale Immunity, Cell Reports Medicine (2020). DOI: 10.1016/j.xcrm.2020.100036

BioCryst launches compassionate use program for angioedema med

BioCryst Pharmaceuticals (NASDAQ:BCRX) has established an expanded access program for oral once-daily berotralstat for patients with hereditary angioedema (HAE), an inherited disorder characterized by recurrent episodes of severe swelling, usually in the limbs, face, intestinal tract and airway.
Under the program, doctors may request the investigational drug for HAE patients who do not have access via a clinical trial.
https://seekingalpha.com/news/3581714-biocryst-launches-compassionate-use-program-for-berotralstat-for-hae

Denali pivots on neuro candidate on safety signals

Citing adverse findings from primate toxicity studies, Denali Therapeutics (NASDAQ:DNLI), together with collaboration partner Sanofi (NASDAQ:SNY), has decided to halt Phase 1b clinical trials evaluating RIPK1 inhibitor DNL747 in Alzheimer’s disease and ALS and focus its resources on accelerating development of DNL788 which, it says, has superior drug properties.
Studies in cynomolgus monkeys showed dose- and duration-dependent adverse findings at exposures higher than those testing in the clinic. The findings, considered off-target and molecule-specific, impact the ability to increase the dose without additional time-consuming safety studies.
RIPK1 (receptor-interacting serine/threonine-protein kinase 1) is a critical signaling protein in the TNF receptor pathway which regulates inflammation and cell death.
https://seekingalpha.com/news/3581726-denali-pivots-on-neuro-candidate-on-safety-signals

Merck’s Keytruda flunks first-line bladder cancer study

A Phase 3 clinical trial, KEYNOTE-361, evaluating the combination of Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and chemo for the first-line treatment of advanced/metastatic urothelial carcinoma (bladder cancer) failed to achieve the primary endpoints of progression-free survival (PFS) or overall survival (OS) compared to chemo alone.
The company says the PD-1 inhibitor demonstrated numerical improvements in PFS and OS but the separations were not statistically significant.
The monotherapy arm was not tested considering the outcome of the combo arm.
No new safety signals were observed.
The FDA has already approved Keytruda for three bladder cancer indications across multiple types and stages.
https://seekingalpha.com/news/3581693-mercks-keytruda-flunks-first-line-bladder-cancer-study

AstraZeneca aims to get COVID-19 therapy into clinic in 2 months

AstraZeneca is planning to start a phase 1 clinical trial of a COVID-19 antibody therapy within two months. The commitment follows the signing of a deal that grants AstraZeneca an exclusive license to six anti-SARS-CoV-2 antibodies identified by researchers at Vanderbilt University.
In April, AstraZeneca outlined a multipronged approach to the discovery of antibodies against the pandemic coronavirus. After receiving the genetic sequences of antibodies identified by Vanderbilt and the Chinese Academy of Sciences, AstraZeneca embarked on a preclinical evaluation that saw it whittle 1,500 prospects down to two molecules that it plans to move into the clinic.
AstraZeneca plans to start testing the two-antibody combination within two months, suggesting an early August start date. The timeline is in keeping with the plans AstraZeneca outlined in April when it set its sights on entering the clinic between July and September.
The two antibodies AstraZeneca plans to test first in humans target different parts of the receptor-binding domain found on the SARS-CoV-2 spike protein. AstraZeneca thinks hitting two targets may increase efficacy and mitigate the risk that the virus will develop resistance against the therapy.
AstraZeneca has entered into an agreement with the Defense Advanced Research Projects Agency (DARPA) to test that hypothesis. DARPA will support the production of antibodies for testing in phase 1 and the trial itself, boosting AstraZeneca’s hopes of being in the clinic within two months.
With Eli Lilly having already initiated dosing in a clinical trial of its AbCellera-partnered antibody, the timeline puts AstraZeneca just behind the front-runners. However, even if more advanced programs generate positive results, the need for an unprecedentedly broad response against a viral pathogen means there could be room for multiple treatments.
AstraZeneca has consistently highlighted the potential for antibodies to prevent infections with the coronavirus, notably in high-risk people who need extra protection to complement a vaccine and individuals who are ineligible for vaccination. Like its peers, AstraZeneca also sees therapeutic uses for its antibodies but it is putting the prophylactic application front and center.
“By combining two monoclonal antibodies that bind to distinct parts of the SARS-CoV-2 spike protein into what potentially could be a single preventative therapy, we hope to improve its effectiveness in neutralizing the virus,” AstraZeneca Executive Vice President Mene Pangalos said in a statement.
AstraZeneca is advancing toward that goal in parallel to other companies. Regeneron is targeting a mid-June start date for a clinical trial of its cocktail of anti-SARS-CoV-2 antibodies, and companies including Amgen and GlaxoSmithKline are also involved in efforts to join Eli Lilly in the clinic.
https://www.fiercebiotech.com/biotech/astrazeneca-aims-to-get-covid-19-therapy-into-clinic-2-months