Abbvie posts new data on drug for far-sightedness

 AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for far-sightedness, which is typically treated with contacts or glasses.

The study of AGN-190584, or pilocarpine formulation, showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing.

In October, Allergan, part of AbbVie, revealed two phase 3 trials of AGN-190584 met their primary endpoints, teeing it up to file for FDA approval. With a decision due by the end of 2021, AbbVie shared a closer look at the results of one of the late-phase studies at this year’s American Society of Cataract and Refractive Surgery annual meeting.

The 323-patient clinical trial assessed participants after 30 days of dosing with either AGN-190584 or placebo. At hour three on day 30, AbbVie linked AGN-190584 to a statistically significant increase in the proportion of subjects who experienced a three-line or greater improvement on a low-light reading chart test, causing the trial to hit its primary endpoint with a p value of less than 0.0001.

AGN-190584 began working in 15 minutes and lasted for up to six hours without a loss of distance vision after administration on day 30, AbbVie said in a statement. The difference in the response rate in the cohorts diminished by hour six, although the p value at that time point was still a statistically significant 0.0114.

Data for other endpoints showed that 75% of patients treated with AGN-190584 experienced at least a two-line improvement on the low-light reading test. Ninety three percent of participants had at least 20/40 vision on a daylight vision test. 

AbbVie saw no treatment-emergent serious adverse events in recipients of AGN-190584. The most common treatment-emergent non-serious adverse event was headache, which affected more than 5% of people. AbbVie said most side effects were mild and transient, adding that 1.2% of patients discontinued due to adverse events.

The data drop sheds light on the results AbbVie hopes will secure FDA approval in presbyopia, the medical name for the condition that makes it more difficult for people to focus on objects close to them over the age of 40 years. Today, people wear reading glasses or contact lenses to manage the condition but companies including AbbVie and Eyenovia see an opportunity for medicines. 

https://www.fiercebiotech.com/biotech/abbvie-posts-pivotal-data-age-related-long-sightedness-drug

Intentionality: Expanding Free Will

 The central problem of psychology is what Freud called the "repetition compulsion".  We repeat patterns of thought, feeling, and/or behavior even though those repetitions interfere with our happiness and success.  We can be fully aware of our maladaptive patterns at certain times and unwittingly repeat them a short while later.  Because our intentionality--our capacity for free will--is limited, our ability to act upon our goals and ideals is also limited.  Every problem of trading psychology ultimately boils down to a restriction of our ability to act upon our best plans and intentions.  The evidence-based approaches to psychology are a collection of techniques that help us become aware of our repetitions, so that we can write new endings to old stories.  At root, good psychology expands our intentionality:  our capacity for free will.

We can develop our capacity for intentional activity by sustaining intentional activity.  One routine that I like on the treadmill is to run with an uphill incline until I become tired and feel like quitting.  Then I decide upon how much further to run.  In other words, I sustain effort beyond the point of discomfort.  That usually means breaking a good sweat.

The problem for most of us is that we rarely break a sweat--in trading or in other areas of life.  We stay in our comfort zones and sustain an action until it becomes uncomfortable.  So, for example, when writing my book I'll eventually become fatigued and feel like taking a break.  That is when I most need to push further and write several more pages.

Similarly, I recently placed a few trades in the morning and got chopped up.  I felt discouraged and decided it was best to pack it in.  On reflection, however, I could tell that this was just discouragement talking; that, in fact, I was now seeing the market clearly.  I pushed forward, redoubled my analysis, hit a point of clarity, placed one more trade, and profited nicely.

Now here's the interesting thing:  When I push further and write a few more pages or do another lap on the treadmill, I break through my fatigue and often can do much more.  After the winning trade, I was not deflated and discouraged at all and felt energized for the rest of my day.  When we push past our comfort levels, we eventually tap into our second wind--a fresh source of energy and enthusiasm.  When we continually make efforts to push past our comfort zones, we become increasingly capable of drawing upon that second wind of consciousness.  

Every effort to sustain activity beyond our comfort zone is an exercise of will.  We are energized when we tap our intentionality.  We lose energy when we remain static, within what is familiar and comfortable.  A great best practice--in trading and in life--is to break a sweat every day by sustaining effort beyond the comfort zone.  As on the treadmill, we find that, over time, that comfort zone expands:  what once took significant effort now comes readily.  Note carefully:  Every part of our trading processes--from our preparation to our reviews--can become opportunities to expand our capacity for effort when we push beyond our comfort zones.

That is the expansion of free will, and it underlies all success--in markets, and in life.

https://traderfeed.blogspot.com/2021/07/intentionality-expanding-free-will.html

Synaptogenix Discloses Further Bryostatin Trial Analyses at Alzheimer's Association

 Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced that its abstract for presentation at the Alzheimer's Association International Conference (AAIC) is now available entitled "Bryostatin Restores Cognitive Functions Above Baseline in Advanced Alzheimer's Disease (AD) Patients: A Regenerative Therapeutic Strategy."

"Recent further analyses of pre-specified cohort results revealed clear evidence of Bryostatin therapeutic efficacy for advanced AD patients. Analyses of treatment benefit, based on mean differences and as a function of successive dosing in the Company's two previous, separate clinical studies (#202 and #203), used each patient as his / her own control in both treatment and placebo groups. While these separate analyses showed treatment benefit, the combined groups in a pooled analysis conducted here produced a highly significant statistical separation of the Bryostatin treatment group (P<.001) from the placebo group. Consolidation of identically enrolled and treated patients in the two clinical trials increased the power (N = 95) of pre-specified Treatment and Placebo groups with the resulting separation. This integrated data analysis provides further encouragement that Bryostatin can make a clinically meaningful difference for treating the underlying pathology and cognitive deterioration of AD – as is now being tested in an NIH-sponsored, six-month clinical trial, incorporating lessons learned from the two previous pilot studies. This potential efficacy involved significant improvement over baseline (> + 4.0 Severe Impairment Battery, SIB, score), not only reduction in the rate of cognitive decline," commented Dr. Daniel Alkon, President and Chief Scientific Officer.

The abstract can be accessed via the following link: https://www.synaptogen.com/wp-content/uploads/2021/07/ESCIOBAADP.pdf

Also, as previously announced, Synaptogenix will hold a conference call for investors to discuss its abstract. The call will take place, today, Monday, July 26th at 4:15pm ET and will be hosted by the Company's Chief Executive Officer, Dr. Alan Tuchman, and its President and Chief Science Officer, Dr. Daniel Alkon. Drs. Tuchman and Alkon will take live Q&A following their prepared remarks.

The U.S. toll free dial-in for the conference call is (877) 407-9205, and the international dial-in number is 1-(201)-689-8054. A live webcast of the conference call will also be available via: https://www.webcaster4.com/Webcast/Page/2599/42216.

https://finance.yahoo.com/news/synaptogenix-discloses-positive-results-further-131500498.html

Cortexyme Presents Evidence of Pathogen as Causative Agent of Alzheimer’ at AAIC 2s021

 New GAIN Trial baseline data demonstrates majority of patients have elevated Von Willebrand factor and alpha-2-macroglobulin

Cortexyme to host AAIC symposium titled "Getting to the Root Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27

Join KOL webinar on atuzaginstat titled "Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration" on Friday, July 30 at 10 a.m. ET

In conjunction with its participation at AAIC 2021, Cortexyme is hosting a key opinion leader (KOL) webinar titled "Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration" on Friday, July 30, 2021, at 10:00 a.m. ET. The webinar will feature KOL Marwan Noel Sabbagh, M.D., (Cleveland Clinic) who will discuss the current treatment landscape of Alzheimer’s disease and dementia, the unmet medical need, as well as recent activity and evidence to support the role of P. gingivalis as an important upstream driver of Alzheimer’s disease pathology. Dr. Sabbagh will also address new baseline data from Cortexyme’s pivotal Phase 2/3 GAIN Trial of atuzaginstat for the treatment of Alzheimer’s disease being presented at AAIC 2021. Cortexyme's management team will provide an update on its ongoing pivotal Phase 2/3 GAIN Trial, which builds on Phase 1 data demonstrating atuzaginstat was well tolerated in both healthy subjects and in patients with Alzheimer’s disease. Dr. Sabbagh and Cortexyme’s management will be available to answer questions following the formal presentations. To register for this webinar, please click here.

https://finance.yahoo.com/news/cortexyme-presents-data-linking-p-130500731.html

BioNTech aims to develop mRNA-based malaria vaccine

 BioNTech wants to build on its success in COVID-19 by developing the first vaccine for malaria based on mRNA technology and aims to start clinical testing by the end on 2022, in an attempt to eradicate the mosquito-borne illness.

The Mainz, Germany-based company, which developed a COVID-19 vaccine with its partner Pfizer, said on Monday it is also exploring vaccine production in Africa as part of efforts to expand manufacturing capacity and increase global access.

“The response to the pandemic has shown that science and innovation can transform people’s lives when all key stakeholders work together towards a common goal,” said BioNTech Chief Executive and co-founder Ugur Sahin.

Scientists around the world have been working for decades to develop a vaccine to prevent malaria that infects millions of people every year and kills more than 400,000 - most of them babies and young children in the poorest parts of Africa.

The world’s first and only licensed malaria vaccine, Mosquirix, was developed by GlaxoSmithKline over many years of clinical trial across several African countries, but is only around 30% effective.

Researchers at Oxford’s Jenner Institute led by Adrian Hill, one of the lead scientists behind the Oxford-AstraZeneca COVID-19 vaccine, are also developing a potential new malaria vaccine that has shown promise in a year-long trial.

MRNA vaccines prompt the human body to make a protein that is part of the virus, triggering an immune response.

BioNTech said it will assess multiple vaccine candidates that target the circumsporozoite protein (CSP), as well as new antigens discovered in pre-clinical research and select the most promising for a clinical trial due to start by the end of 2022.

The company is also evaluating setting up mRNA vaccine production in Africa, either with partners or on its own, as part of efforts to scale up manufacturing capacity in low- and middle-income countries.

BioNTech did not disclose how the project would be funded, but said the World Health Organisation (WHO), European Commission and other organisations have offered their support to set up the necessary infrastructure.

BioNTech also plans to start a clinical trial to test a vaccine candidate for tuberculosis in 2022 and is working with partners to develop vaccines against nine different infectious diseases as well as for cancer.

https://www.reuters.com/article/us-health-coronavirus-biontech-malaria/biontech-aims-to-develop-mrna-based-malaria-vaccine-idUSKBN2EW1NU

ATI Physical Therapy Reports Q2, Revises 2021 Forecast

 ATI Physical Therapy – ("ATI" or the "Company") (NYSE: ATIP), the largest independent outpatient physical therapy provider in the United States, today reported financial results for the second quarter ended June 30, 2021.

Labeed Diab, Chief Executive Officer, said, "We are seeing growing demand for ATI's services, and visit volume increased during the second quarter. However, the acceleration of attrition among our therapists in the second quarter and continuing into the third quarter, combined with the intensifying competition for clinicians in the labor market, prevented us from being able to meet the demand we have and increased our expectations for labor costs. We are implementing a range of actions related to compensation, staffing levels and other items to retain and attract therapists across our platform to meet our currently underserved patient demand. We expect therapist headcount to be below previously anticipated levels for 2021 which, combined with elevated costs for therapists and an unfavorable revenue mix, has caused us to reduce our forecast for 2021. We continue to have confidence in the underlying fundamentals driving our business and our ability to leverage our strong position in the market to drive growth and value over time."

For full year 2021, ATI is now projecting revenue to be in the range of $640 million to $670 million and Adjusted EBITDA to be in the range of $60 million to $70 million, down from $731 million and $119 million, respectively. ATI does not intend to provide revenue guidance as a future guidance metric. The revised expectations reflect the impact of the following developments which are partially offset by continued strong demand for ATI's services:

• The acceleration of attrition in the second quarter and continuing into the third quarter caused, in part, by changes made during the COVID-19 pandemic related to compensation, staffing levels and support for clinicians. ATI has taken swift actions to offset those changes, but the company expects the impact of attrition in the second and third quarters will impact overall profitability for the year.

• Labor market dynamics that increased competition for the available physical therapy providers in the workforce, creating wage inflation and elevated employee attrition at ATI, negatively affecting our ability to capitalize on continued customer demand.

• Decrease in rate per visit primarily driven by continuing less favorable payor and state mix when compared to pre-pandemic profile, with general shift from workers compensation and auto personal injury to commercial and government, and further impacted by mix-shift out of higher reimbursement states.

Largely in response to the accelerated attrition, ATI is lowering its estimate for new clinic openings, (i.e., de novo and acqui-novo clinics), to be in the range of 55 to 65 clinics from 90 clinics. Our ability to achieve our revised forecast for the remainder of 2021 depends upon a number of factors, including the success of a number of steps being taken to significantly reduce attrition of physical therapists and significant hiring of physical therapists.

The Company has determined that the revision to its 2021 forecast constitutes an interim triggering event that requires further analysis with respect to potential impairment to goodwill and trade name intangible assets. Accordingly, the Company is currently performing interim quantitative impairment testing during the third quarter of 2021. If it is determined that the fair value amounts are below the respective carrying amounts, the Company will record an impairment charge which could be material.

https://finance.yahoo.com/news/ati-physical-therapy-reports-second-110000451.html

Oramed to Start Trials For Oral COVID Vax In Israel, Outlicensed Injectable Vax In India

 Oramed Pharmaceuticals Inc (NASDAQ: ORMP) announced several updates for its majority-owned company Oravax Medical Inc.

• Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally.

• The Institutional Review Board (IRB) in Israel has approved the study protocol and is now pending approval from the Israeli Ministry of Health.

• GMP manufacturing for the oral vaccine is underway.

• It is the exclusive owner of a virus-like particle (VLP) vaccine technology that targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially effective against current and future variants.

• The VLP vaccine is being tested in preclinical studies against COVID-19 variants, including the Delta variant.

• Oramed is currently evaluating several options concerning its interest in Oravax, including distributing a portion of its holdings to its shareholders.

• Oravax has out-licensed certain rights in the territory of India to Premas Biotech, the original developer of the novel vaccine.

• It has licensed Premas the right to develop an injectable version of its VLP technology.

https://finance.yahoo.com/news/oramed-soon-start-clinical-trials-154451533.html