Starpharma’s nasal spray shows positive effect against COVID-19

Starpharma (OTCQX:SPHRY +8.7%) has completed additional antiviral testing for SPL7013 against SARS‑CoV-2 in lab studies conducted at Scripps Research Institute in the U.S.

The latest results confirm that when SPL7013 is applied at the concentration of the SPL7013 COVID-19 nasal spray, it has potent virucidal activity, inactivating more than 99.9% of SARS-CoV-2.

SPL7013 is a broad-spectrum antiviral, that inactivates viruses by blocking the interaction between viral surface proteins and the human cell receptor proteins.

https://seekingalpha.com/news/3613772-starpharma-s-covidminus-19-nasal-spray-shows-positive-effect-against-covidminus-19

FDA stays pause of AstraZeneca Covid vax study to probe possible safety signal

Reuters reports that the FDA has not given the green light to resume the U.S. portion of AstraZeneca’s (NYSE:AZN) pivotal study of COVID-19 vaccine candidate AZD1222.

The trial was suspended after a UK participant fell ill after inoculation. Enrollment has restarted there but will remain on hold in the U.S. while the FDA and a safety panel investigate the event. Enrollment of new participants and other procedures have been rescheduled until at least Wednesday although it is unclear how long the FDA inquiry will take.

The trial in Brazil has restarted as well. The status of studies in South Africa and India is unknown.

https://seekingalpha.com/news/3613824-fda-maintains-pause-of-astrazenecas-covidminus-19-vaccine-study-to-investigate-potential

Neurocrine launches Parkinson’s therapy as COVID linked disruptions ease

Neurocrine Biosciences Inc on Monday launched its add-on treatment for patients with Parkinson’s disease nearly five months after Food and Drug Administration’s approval, as the COVID-19 pandemic delayed its roll out in the United States.

Since the pandemic’s outbreak, drugmakers’ sales representative were restricted from meeting doctors busy with COVID-19 patients, but now they are open to such meetings to discuss new drugs. This made it an appropriate time to launch Ongentys, Neurocrine Chief Executive Officer Kevin Gorman said.

“We had two challenges that kept us from launching immediately after the approval. One was – there was big hiccup in the supply chain and then obviously COVID was very fresh and new at that point of time,” Gorman said.

Lockdowns led by the COVID-19 pandemic delayed or slowed the launch of several drugs as drugmakers faced disruptions to business after health authorities issued restrictions to control the fast spreading virus.

In April, Neurocrine said it was working on a supply issue with its partner, Portugal-based BIAL Portela & Ca SA.

Ongentys helps prolong the effect of levodopa, the standard of care drug for Parkinson’s. As the disease progresses, levodopa’s effectiveness wears off and patients begin to experience problems with their movement.

Neurocrine in June said that a month’s supply of the drug, approved by the FDA on April 24, would have a list price of $590, a little below the range of other similar drugs in the market that are priced at $670 a month.

https://www.reuters.com/article/us-neurocrine-parkinsons/neurocrine-launches-parkinsons-therapy-as-covid-19-related-disruptions-ease-idUSKBN2651ZB

Inhaled versions of Oxford and Imperial COVID-19 vaccine candidates in trial

Inhaled versions of COVID-19 vaccine candidates developed by Oxford University and Imperial College will be trialled to see if they deliver a localised immune response in the respiratory tract, British researchers said on Monday.

The Oxford and Imperial vaccines are both being tested in trials through intramuscular injection, but scientists from Imperial said that vaccines delivered via inhalation could potentially deliver a more specialised response.

Chris Chiu, of Imperial’s Department of Infectious Disease, said there was evidence that flu vaccines delivered by nasal spray could protect against and reduce transmission of the disease.

“We are keen to explore if this may also be the case for SARS-CoV-2 and whether delivering COVID-19 vaccines to the respiratory tract is safe and produces an effective immune response,” he said in a statement.

Trials of the Oxford vaccine, which has been licensed to AstraZeneca, resumed at the weekend after safety watchdogs gave it the go-ahead. Late-stage trials had been paused after study subject fell in Britain.

“We have already shown that (Oxford vaccine) ChAdOx1 nCoV-19 (AZD1222) is safe and induces strong immune responses after intramuscular injection,” said Sarah Gilbert of the University of Oxford.

“Delivering the vaccine to the respiratory tract instead may be a good approach to inducing immune responses in the best place to enable a rapid response after exposure to airborne virus.”

Imperial’s vaccine is also in clinical trials, although at an earlier stage.

The new trials of the vaccines will see volunteers receive aerosolised vaccines through a nebulizer, delivering the vaccine as airborne droplets through a mouthpiece. A total of 30 people will be recruited to the trials.

Previous studies suggest that lower doses might be required than in intramuscular injections to give protection, the Imperial researchers said.

https://www.reuters.com/article/us-health-coronavirus-vaccines-inhaled/researchers-trial-inhaled-versions-of-oxford-and-imperial-covid-19-vaccine-candidates-idUSKBN2652V0

AstraZeneca shares gain as coronavirus vaccine trials resume

Shares of AstraZeneca AZN.L inched higher in early trade on Monday as the optimism spurred by the British drugmaker’s resumption of clinical trials for its COVID-19 vaccine candidate outweighed official weekend moves to cut U.S. drug prices.

The stock was the biggest boost to London’s bluechip, FTSE 100 .FTSE index in early trading, but quickly pared gains as U.S. President Donald Trump’s order to lower prices nationally hurt pharmaceutical stocks across the board.

AstraZeneca shares were trading at 8,431 pence by 0833 GMT. UK pharma stocks .FTNMX4570, however, underperformed the FTSE 100, with GSK GSK.L down 0.2% and Hikma HIK. 1% on Trump’s order.

The resumption of the trials for AstraZeneca’s vaccine, one of the most advanced in development and regarded by governments and financial markets as one of the best bets to tackle the health crisis in the months ahead, buoyed stock markets around the world.

Late-stage trials of the vaccine were suspended last week after an illness in a study participant, casting doubts on an early rollout and sending the London-listed company’s shares lower.

Global trials of the vaccine had also been paused following the UK suspension. Brazil has approved restarting the trials and the Serum Institute of India is awaiting permission from the Drugs Controller General of India.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-stocks/astrazeneca-shares-gain-as-coronavirus-vaccine-trials-resume-idUSKBN2650TD

Novartis aims to expand eye med Beovu use after safety fears hurt launch

Novartis’s Beovu matched Regeneron’s Eylea in vision clarity scores for a blindness-causing eye disease, the Swiss drugmaker said on Monday, after early safety stumbles for the medicine in another condition caused disappointing early sales.

In addition to proving non-inferior to Eylea in visual acuity in diabetic macular edema (DME) patients after a year of treatment, Novartis also underscored Beovu’s less-frequent dosing. More than half of those who got Beovu stayed on a once-every-three-months dosing schedule, it said in a statement, with Eylea patients dosed every two months.

Novartis said it will assess next steps in getting approval for Beovu in DME.

“This data confirms our strong belief in Beovu as a potential therapy for DME patients,” said Dirk Sauer, who leads Novartis Pharma Ophthalmology’s drug development.

Beovu was approved in February for age-related macular degeneration, another blindness causing condition, but Novartis was forced just weeks later to launch an external safety review after the American Society of Retinal Specialists (ASRS) raised concerns about rare cases of sight-threatening retinal vasculitis or retinal vascular occlusion.

While Beovu remains on sale and Novartis has promoted its favourable risk-benefit profile, the European Medicines Agency on Monday followed U.S. regulators in updating its safety label to include a special warning urging patients that experience such inflammatory events to discontinue use.

Novartis, whose Chief Financial Officer Harry Kirsch in July said the sluggish Beovu launch was among factors that weighed on sales growth, is continuing to examine the cause of such adverse events, and how best to treat them when they arise.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-aims-to-expand-Beovu-use-after-safety-fears-hurt-launch-31287267/

Regeneron anti-viral antibody meds to be weighed in Oxford Phase 3 RECOVERY trial

Regeneron Pharmaceuticals (NASDAQ:REGN) and the University of Oxford announce that RECOVERY (Randomised Evaluation of COVID-19 Therapy), will evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2.

The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

Other endpoints include the impact on hospital stay and the need for ventilation. It is anticipated that at least 2,000 patients will be enrolled in the study.

The inclusion of convalescent plasma in the RECOVERY trial was announced in June. The trial will compare adding convalescent plasma to usual standard-of-care versus standard-of-care on its own.

An Independent Data Monitoring Committee is monitoring all Regeneron-led REGN-COV2 Phase 2 and 3 trials, and all trials continue to enroll patients.

REGN-COV2 comprises two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2.

https://seekingalpha.com/news/3613563-regenerons-anti-viral-antibody-cocktail-to-be-evaluated-in-oxfords-phase-3-recovery-trial