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Friday, June 12, 2020

FDA OKs expanded use of ViiV HIV med Tivicay

The FDA approves ViiV Healthcare’s Tivicay (dolutegravir) for the treatment of HIV-1 infection in children as young as four weeks old and weighing at least 3 kg, in combination with other antiretroviral treatments.
The agency approved the HIV-1 integrase strand transfer inhibitor in August 2013 for HIV-1-positive patients at least 12 years old and weighing at least 40 kg.
ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK -0.3%), Pfizer (PFE +0.3%) and Shionogi (OTCPK:SGIOY +1.3%).
https://seekingalpha.com/news/3582747-fda-oks-expanded-use-of-viiv-hiv-med-tivicay

Principia’s rilzabrutinib shows positive effect in rare skin-blistering disorder

Principia Biopharma (NASDAQ:PRNB) announces positive results from Part B of a Phase 2 clinical trial, BELIEVE-PV, evaluating oral BTK inhibitor rilzabrutinib in patients with pemphigus, a group of rare autoimmune disorders characterized by blisters or sores on the skin. The data were virtually presented at the American Academy of Dermatology Annual Meeting.
At week 24, the complete remission rate was 40% while the median corticosteroid dose was reduced to 6 mg. 60% and 87%, respectively, of patients achieved control of disease activity (CDA) by week 4 and week 12.
A Phase 3 study is underway.
https://seekingalpha.com/news/3582781-principias-rilzabrutinib-shows-positive-effect-in-rare-skin-blistering-disorder

CDC warns on another round of lockdowns

Speaking at a press briefing, the CDC’s Jay Butler says “mitigation efforts” similar to March, i.e. economic shutdown, may be necessary should cases “dramatically” rise.
At the moment there are a number of report of rising cases in reopened areas – by itself not too much of an issue if the rise correlates to a rise in testing (though a Morgan Stanley report yesterday suggests otherwise). But there are also reports of rising hospitalizations – again, by itself not a huge issue if that correlates to folks headed back to hospitals for elective surgeries.
https://seekingalpha.com/news/3582749-cdc-warns-on-another-round-of-lockdowns

Lilly’s lebrikizumab shows encouraging action in dermatitis study

Eli Lilly (LLY -0.3%) announces new data from a Phase 2b clinical trial evaluating lebrikizumab in patients with moderate-to-severe atopic dermatitis (AD). The results were virtually presented at the American Academy of Dermatology Annual Meeting. Key findings:
Itch by day 2 improved to week 16.
Sleep by the first on-treatment assessment at week 1 which improved to week 16.
Disease severity improved by the first on-treatment assessment at week 16.
Quality of life measures improved.
Five Phase 3 studies are underway.
Lebrikizumab is an injectable humanized monoclonal antibody that binds to (inhibits) a pro-inflammatory protein called interleukin-13 (IL-13).
Lilly obtained the rights to the candidate via its $1.1B acquisition of Dermira in February.
https://seekingalpha.com/news/3582761-lillys-lebrikizumab-shows-encouraging-action-in-dermatitis-study

Roche’s risdiplam shows treatment benefit in SMA studies

Roche (OTCQX:RHHBY) unit Genentech announces positive results from two clinical trials evaluating risdiplam in patients with spinal muscular atrophy (SMA).
An exploratory analysis of the Phase 2/3 SUNFISH study in patients with type 2 or 3 SMA showed that risdiplam significantly improved motor function after 24 months of treatment.
Preliminary 12-month data from the Phase 2 JEWELFISH trial in patients with all SMA types showed that treatment with risdiplam led to rapid and sustained increases in survival motor neuron (SMN) protein levels.
No new safety signals were observed.
The company’s U.S. marketing application is currently under FDA review with an action date of August 24.
Risdiplam is a survival motor neuron-2 (SMN2) splicing modifier designed to increase and sustain SMN protein levels throughout the central nervous system and in peripheral tissues.
Related ticker: PTC Therapeutics (NASDAQ:PTCT)
https://seekingalpha.com/news/3582789-roches-risdiplam-shows-treatment-benefit-in-sma-studies

AbbVie reports additional data from successful study of Skyrizi in psoriasis

Following up on its initial announcement in January, AbbVie (ABBV +0.1%) announces additional data from a Phase 3 clinical trial, IMMerge, comparing Skyrizi (risankizumab-rzaa) to Novartis’ (NVS -0.3%) Cosentyx (secukinumab) in patients with moderate-to-severe plaque psoriasis.
The study met both primary endpoints related to the proportion of treated patients achieving PASI 90 (90% skin clearance) at week 16 (non-inferiority) and 52 (superiority) versus Cosentyx.
The new data showed Skyrizi’s superiority as measured by the proportion of patients achieving PASI 100 (clear skin) at week 52. Specifically, 66% of patients in the Skyrizi arm achieved totally clear skin compared to 40% in the Cosentyx arm (p<0.001).
The FDA approved Skyrizi for plaque psoriasis in April 2019.
https://seekingalpha.com/news/3582753-abbvie-reports-additional-data-from-successful-study-of-skyrizi-in-psoriasis

Short regimen hydroxychloroquine plus azithromycin in non-severe Covid-19

José A. Oteo, Pedro Marco, Luis Ponce de León, Alejandra Roncero, Teófilo Lobera, Valentín Lisa

Abstract

The new SARS-CoV-2 infection named COVID-19 has severely hit our Health System. At the time of writing this paper no medical therapy is officially recommended or has shown results in improving the outcomes in COVID-19 patients. With the aim of diminishing the impact in Hospital admissions and reducing the number of medical complications, we implemented a strategy based on a Hospital Home-Care Unit (HHCU) using an easy-to-use treatment based on an oral administration regimen outside the hospital with hydroxychloroquine (HCQ) plus azithromycin (AZM) for a short period of 5 days. Patients and methods: Patients ≥ 18 years old visiting the emergency room at the Hospital Universitario San Pedro de Logrono (La Rioja) between March, 31st and April, 12th diagnosed with COVID-19 with confirmed SARS-CoV-2 infection by a specific PCR, as follows: Patients with pneumonia (CURB ≤ 1) who did not present severe comorbidities and had no processes that contraindicated this therapeutic regime. Olygosimptomatic patients without pneumonia aged ≥ 55 years. Patients ≥ 18 years old without pneumonia with significant comorbidities. We excluded patients with known allergies to some of the antimicrobials used and patients treated with other drugs that increase the QTc or with QTc >450msc. The therapeutic regime was: HCQ 400 mg every twice in a loading dose followed by 200 mg twice for 5 days, plus AZM 500 mg on the first day followed by 250 mg daily for 5 days. A daily telephone follow-up was carried out from the hospital by the same physician. The end-points of our study were: 1.- To measure the need for hospital admission within 15 days after the start of treatment. 2.- To measure the need to be admitted to the intensive care unit (ICU) within 15 days after the start of the treatment. 3.- To describe the severity of the clinical complications developed. 4.- To measure the mortality within 30 days after starting treatment (differentiating if the cause is COVID-19 or something else). 5.-To describe the safety and adverse effects of the therapeutic regime. Results: During the 13 days studied a total of 502 patients were attended in the emergency room due to COVID-19. Forty-two were sent at home; 80 were attended by the HHCU (patients on this study) and 380 were admitted to the Hospital. In our series there were a group of 69 (85.18%) patients diagnosed with pneumonia (37 males and 32 females). Most of them, 57 (82.60%) had a CURB65 score of <1 (average age 49) and 12 (17.40%) a CURB score of 1 (average age 63). Eighteen (22.50%) of the pneumonia patients also had some morbidity as a risk factor. 11 patients (13.75%) without pneumonia were admitted to the HHCU because comorbidities or age ≥ 55 years. Six patients with pneumonia had to be hospitalized during the observation period, 3 of them because side effects and 3 because of worsening. One of these patients, with morbid obesity and asthma, had clinical worsening needing mechanical ventilation at ICU and developed acute distress respiratory syndrome. With the exception of the patient admitted to the ICU, the rest of the patients were discharged at home in the following 8 days (3 to 8 days). Twelve patients (15%), 11 of whom had pneumonia, experienced side effects affecting mainly the digestive. In another patient a QTc interval prolongation (452 msc) was observed. In total 3 of these patients had to be admitted in the Hospital, 2 because of vomiting and 1 because a QTc interval lengthening. None of the patients needed to stop the HCQ or AZM and all the 80 patients finished the therapeutic strategy. From the group without pneumonia only a patient developed diarrhea that did not require hospitalization or stop the medication. Conclusions: Our strategy has been associated with a reduction in the burden of hospital pressure, and it seems to be successful in terms of the number of patients who have developed serious complications and / or death. None of the patients died in the studied period and only 6 have to be admitted in conventional hospitalization area.

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https://www.medrxiv.org/content/10.1101/2020.06.10.20101105v1