Healthcare Roundup – First case of COVID-19 reinfection confirmed in the U.S.; Relief/NeuroRx reports encouraging Aviptadil data

医疗保健精选——美国确认首例新冠二次感染病例,Relief/NeuroRx报告令人鼓舞的Aviptadil数据
Published on: October 13, 2020
Author: Amy Liu

First case of COVID-19 reinfection confirmed in the U.S.

It’s the first confirmed case of a U.S. patient becoming reinfected with COVID-19, and the fifth known case reported worldwide.

The 25-year-old man, who was a resident of Washoe County in Nevada, became seriously ill following the second infection, a study in the Lancet Infectious Diseases journal showed, raising further questions about coronavirus immunity.

A comparison of genetic codes showed “significant differences” between each virus variant, meaning the patient caught the coronavirus on two separate occasions, rather than the original infection bouncing back after becoming dormant.

Reports of secondary coronavirus infections in Hong Kong, the Netherlands and Belgium were no more serious than the first, but one in Ecuador mirrored the U.S. case in being more severe.

“I think we’re facing a whole lot of trouble,” Dr. Anthony Fauci said Monday evening. “We have a baseline of infections now that vary between 40,000 and 50,000 per day. That’s a bad place to be when you’re going into the cooler weather of the fall, and the colder weather of the winter. In addition, we would like to see the percent positivity be coming down.”

Related vaccine makers: Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and Moderna (NASDAQ:MRNA), BioNTech (NASDAQ:BNTX), Novavax (NASDAQ:NVAX), Inovio Pharmaceuticals (NASDAQ:INO), AstraZeneca (NYSE:AZN), Dynavax (NASDAQ:DVAX), GlaxoSmithKline (NYSE:GSK), iBio (NYSEMKT:IBIO), Altimmune (NASDAQ:ALT) and VBI Vaccines (NASDAQ:VBIV).

Relief/NeuroRx reports encouraging Aviptadil data in patients with COVID-19 respiratory failure

Relief Therapeutics (OTCQB:RLFTF) and NeuroRx announce topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to ICU with critical COVID-19 and respiratory failure were treated with RLF-100 (Aviptadil) compared to 24 control patients treated in the same setting.

All patients had severe comorbidities that rendered them ineligible for the ongoing randomized controlled phase 2b/3 trial.

Overall, 81% of RLF-100-treated patients survived beyond 60 days, compared to 17% of control patients.

Patients treated with RLF-100 demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance.

Top-line data from placebo-controlled Phase 2b/3 trial are expected this quarter.

Sanofi/Regeneron Dupixent reduces asthma attacks and improves lung function in children

A pivotal Phase 3 trial of Sanofi (NASDAQ:SNY) and Regeneron’s (NASDAQ:REGN) Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The trial enrolled 408 children.

In a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils or elevated fractional exhaled nitric oxide, Dupixent added to standard of care significantly reduced asthma attacks and improved lung function, as early as two weeks after the first dose, compared to standard of care alone.

Reduced rate of severe asthma attacks, with a 65% and 59% average reduction over one year was observed in patient dosed with Dupixent compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively).

Improved lung function at 12 weeks compared to baseline by 10.15 and 10.53 percentage points for Dupixent vs. 4.83 and 5.32 percentage points for placebo, respectively.

Safety results were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older.

Johnson & Johnson beats on earnings, raises FY20 guidance

Johnson & Johnson (NYSE:JNJ): Q3 Non-GAAP EPS of $2.20 beats by $0.22; GAAP EPS of $1.33 misses by $0.37.

Revenue of $21.08B (+1.7% Y/Y) beats by $930M.

Darzalex revenue of $1.1B vs. estimate $1.01B.

Imbruvica revenue of $1.03B compared to consensus of $1.08B.

2020 Guidance: Revenues: $81.2B-82.0B from $79.9B-81.4B ($80.66B consensus). Non-GAAP EPS: $7.95-8.05 from $7.75-7.95 prior ($7.89 consensus).

Shares -0.98% PM.

Dynavax/Medigen’s adjuvanted COVID-19 vaccine bags $16.4M subsidy in Taiwan

Dynavax Technologies (NASDAQ:DVAX) and Medigen Vaccine Biologics (MVC) announce that latter has obtained a Taiwan government subsidy in amount of up to NT$472M ($16.4M) for successfully initiating a Phase 1 clinical trial in Taiwan for R&D of a locally produced COVID-19 vaccine.

The first participant in Phase 1 trial was dosed with MVC’s COVID-19 vaccine combined with Dynavax’s CpG 1018 adjuvant in early October.

MVC’s Phase 1 study is an open-label, dose-escalation study intended to assess the safety and immunogenicity of the stable prefusion form of SARS-CoV-2 recombinant spike protein S-2P at three dose levels (low, medium and high) adjuvanted with CpG 1018 plus alum in ~45 healthy subjects.

“The pre-clinical study results demonstrated that the combination of our S-2P vaccine candidate and CpG 1018 plus alum provided safety and immunogenicity sufficient to advance to Phase 1 development,” said Charles Chen, CEO of MVC.

DVAX shares up 7% premarket.

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