- Apellis Pharmaceuticals (NASDAQ:APLS) has initiated registrational programs of pegcetacoplan for C3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases, and amyotrophic lateral sclerosis (ALS), a rare neurodegenerative disease that leads to progressive muscle weakness and paralysis.
- The company will commence Phase 2 NOBLE study in 12 C3G / IC-MPGN patients, with first patients to be dosed by the end of this year. Primary endpoint is the proportion of patients with reduction in C3c staining on renal biopsy after 12 weeks of treatment. It also plans to begin a Phase 3 study in 1H of 2021 with reduction in proteinuria (excess proteins in the urine) as its primary endpoint.
- Apellis is expanding pegcetacoplan development into neurology with a potentially Phase 2 study in ALS. MERIDIAN study has been initiated in ~200 patients, with first patient to be dosed by end of this year. Primary endpoint is the Combined Assessment of Function and Survival rank scores at week 52.
- Last month, the company submitted a marketing application for pegcetacoplan for rare blood disease, in the U.S. and European Union.
- https://seekingalpha.com/news/3619738-apellis-initiates-mid-stage-pegcetacoplan-studies-in-rare-kidney-and-neurological-diseases
Monday, October 5, 2020
Apellis initiates mid-stage pegcetacoplan studies in rare kidney, neurological diseases
Sunday, October 4, 2020
Bronx-Based Elevator Manufacturer's New Tech Fights COVID-19
CEC Elevator Cab Corp. officially announced its latest innovative contribution to the elevator manufacturing business: Sterilyft (https://www.sterilyft.com/). Sterilyft is a completely unique elevator air filtration and sterilization system made in America to fight the current pandemic, and prevent future pathogenic spread. Sterilyft uses the germicidal power of UV-C light to kill pathogens, double MERV 13 filtering and then adding purified air back into the elevator cab space in a closed loop arrangement. CEC Elevator Cab Corp. manufactures Sterilyft in its Bronx-based facility, and has already installed the system in seven different states across the U.S., with plans to fill recent orders across the globe.
Sterilyft's pathogen-fighting technology is based upon several already tested and proven principles currently in use today: UV-C irradiation for sterilization purposes, high efficiency filtering of contaminants from air, and use of forced air and a semi-closed loop system to recirculate purified air back into the sanitized space.
New three-tier lockdown planned for England
A new three-tier lockdown is being planned for England, The Guardian reported, citing leaked government documents which revealed tougher measures that could be implemented locally or nationally if the government fails to get COVID-19 cases under control.
The new lockdown would potentially entail harsher restrictions including the closure of pubs and a ban on all social contact outside household groups, the newspaper said https://bit.ly/3iz0GbQ.
According to the documents seen by The Guardian, the draft
plan called the 'COVID-19 Proposed Social Distancing Framework'
is designed to simplify the existing localized restrictions.
The plans have not yet been finalised and signed off by No.10 officials and several of the measures could still be relaxed, according to the newspaper.
Britain gradually came out of a national lockdown over the summer, but many areas including major cities such as Manchester and Glasgow are currently subject to local restrictions.
In an interview on Sunday British Prime Minister Boris Johnson denied a suggestion that the local restrictions were not working given infection rates were still rising in the affected areas and there was no end in sight to the measures.
The three-tier system is aimed at improving people's compliance with the rules, the Guardian said, stating that many citizens do not have a clear understanding of the rules that apply to them.
The levels are intended to be 'minimum standards' and specific local circumstances would also be taken into account, the newspaper said, citing a government source.
The government had last week announced a tightening of restrictions on socializing in northeast England, in response to high and increasing COVID-19 infection rates in the region - the latest in a series of local measures.
https://www.marketscreener.com/news/latest/New-three-tier-lockdown-planned-for-England-The-Guardian--31476172/
India, South Africa ask WTO to waive rules to aid COVID-19 drug production
India and South Africa want the World Trade Organization (WTO) to waive intellectual property rules to make it easier for developing countries to produce or import COVID-19 drugs, a letter here&Open=True to the WTO shows.
In their letter dated Oct. 2 the two countries called on the global trade body to waive parts of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which governs patents, trademarks, copyright and other intellectual property rules globally.
“As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there are significant concerns (over) how these will be made available promptly, in sufficient quantities and at (an) affordable price to meet global demand,” the letter posted on the Geneva-based WTO’s website says.
The two countries said that developing nations are disproportionately affected by the pandemic and that intellectual property rights, including patents, could be a barrier to the provision of affordable medicine.
The letter asks that the WTO’s Council for TRIPS recommends a waiver to the General Council, the WTO’s top decision-making body in Geneva, “as early as possible”. It does not say how much support India and South Africa have from other countries.
A draft General Council decision text submitted with the letter says the waiver should last an as yet unspecified number of years and be reviewed annually.
https://www.reuters.com/article/us-health-coronavirus-wto/india-and-south-africa-ask-wto-to-waive-rules-to-aid-covid-19-drug-production-idUSKBN26P0H1
Vaccine task force head says vaccinating all of UK 'not going to happen'
Britain’s vaccine task force chair, Kate Bingham, said that vaccinating everyone in the country for the coronavirus was ‘not going to happen’, telling the Financial Times that they need to vaccinate only those at risk.
"There's going to be no vaccination of people under 18. It's an adult-only vaccine, for people over 50, focusing on health workers and care home workers and the vulnerable", Bingham said in an interview with the newspaper.
https://www.reuters.com/article/us-health-coronavirus-britain-vaccine/uks-vaccine-task-force-head-says-vaccinating-all-of-uk-not-going-to-happen-ft-idUSKBN26P0YX
U.S. committee details planned phased deployment of COVID-19 vaccines
- Clarifying the specific nature of how best to deploy scarce initial supplies of COVID-19 vaccines if and when approved, a special committee formed by the National Academies of Science, Engineering and Medicine recommends a staged rollout that prioritizes vulnerable populations of Americans. Key points:
- Phase 1a, covering 5% of the U.S. population, would be first. This group includes front-line health workers, workers who provide transportation and other services to healthcare facilities and first responders (police, firefighters, EMTs).
- Phase 1b, covering 10% of the population, would include people with health conditions that put them at higher-risk of severe COVID-19 or death and seniors at least 65 years of age who live in nursing homes, long-term care facilities, homeless shelters and prisons.
- Phase 2, covering another 30-35%, would include teachers and school staff for grades K-12, child-care workers and workers in high-risk settings who cannot avoid risk of exposure (e.g., food supply, public transit).
- Phase 3, covering another 40-45%, would include young adults, children and workers in colleges and hotels.
- Phase 4 would cover everyone else.
- Other recommendations include no out-of-pocket costs for getting vaccinated (personal expenses, even if low, would dampen demand).
- The feds plan to begin shipping doses within 24 hours of emergency use authorization which could happen this quarter.
- https://seekingalpha.com/news/3619650-u-s-committee-details-planned-phased-deployment-of-covidminus-19-vaccines
NYC Closes Schools, Restaurants In 9 COVID-19 Hots Spots In 1st Rollback Since Start Of Pandemic
In NYC, and, to a lesser extent, other parts of southern New York State, a relatively mild resurgence in new cases has prompted political leaders to reimpose restrictions on businesses.
On Sunday, NYC Mayor Bill de Blasio revealed that the city will close schools (just days after they re-opened on their staggered schedule following 2 prior delays) once again, and businesses in the hard-hit COVID-19 "hot spots" cropping up around the city.
“Today, unfortunately, is not a day for celebration,” Mayor de Blasio said. "Today is a more difficult day," though to be fair, that could describe any day in the de Blasio administration.
The mayor's plan, which must still be approved by Gov Andrew Cuomo, the mayor's political archrival, marks the first major reversal in the city's reopening plan since the outbreak began, according to the NYT.
Nine ZIP codes include portions of Far Rockaway, Borough Park, Midwood, Gravesend, Bensonhurst, Sheepshead Bay and Kew Gardens are being targeted by the order. The city is also closely watching 11 additional ZIP codes that de Blasio said were a "real concern."
In the 9 affected neighborhoods, indoor dining - which it only just re-started last month - will be curtailed, along with outdoor. Schools, both public and private, will also be shuttered. Since many of the neighborhoods include ultraorthodox Jewish populations, the rule will apply to private Yeshivas, where Jewish students are educated. De Blasio said he will "rewind" the reopening of schools in the zip codes now that all 9 zip codes affected have seen their 7-day positivity rate climb back above 3%.
De Blasio's plan comes as new cases in NY retreated back below 1,500 on Sunday, according to a tweet from Gov. Cuomo, who also announced Sunday that the state would take over supervision of 20 'hot spots' around the state, including many in NYC. Cuomo announced his plan roughly an hour before de Blasio announced his.
"When the state does enforcement, we do enforcement," Cuomo said. Notably, nothing about Cuomo's plan conflicts with de Blasio's, which is expected to be approved by the state.
Cuomo hinted at plans to intensify social distancing and mask-wearing enforcement in 'hot spots' yesterday.
Most of the hot spots are in New York City, in Brooklyn and Queens, but also counties including Hudson and Orange. Cuomo said the Orthodox Jewish communities in many of these hot spots have been cooperating with efforts to lower the numbers. Across the 20 spots, the aggregate positive test rate is 4.8%, he said. Minus those areas, the state's overall rate falls to 0.9%, in line with the recent overall low trend in New York. Outbreaks in these "hotspots" are driving infection rates to their highest levels since NY's reopening.
The return to restrictions could be the kiss of death for more restaurants and small businesses in those areas, which have been struggling to hold on. It also offers a preview of how President Biden might run things until a vaccine is widely available.
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