Celltrion has announced that it has submitted an Investigational New Drug (IND) application for its inhaled COVID-19 antibody treatment and plans to begin a global phase 3 clinical trial to assess the treatment’s safety and effectiveness.

The COVID-19 antibody treatment is made up of regdanvimab and CT-P63, with the two monoclonal antibodies combined to target new strains of coronavirus, including the highly transmissible Omicron variant.

The company expects to enrol around 2,200 people with mild-to-moderate symptoms of COVID-19 in the trial.

The treatment uses an antibody platform which directly traps the virus in mucus found in the patient’s airway, thereby preventing localised infection. This helps to rapidly eliminate the virus from the lungs via the body’s natural ability to rid itself of mucus.

One of the benefits of the inhaled treatment is that it can be readily self-administered by patients, using a nebuliser, thus reducing the pressure on healthcare staff to assist with treatment and reducing clinic space usually needed for patients requiring intravenous drugs.

Dr HoUng Kim, head of medical and marketing division at Celltrion Healthcare, said: “An inhalable treatment can be self-administered in at-home settings, and at a scale not achievable using the conventional inpatient intravenous infusion treatments.”

The World Health Organization (WHO) has reported that the BA.2 subvariant of Omicron coronavirus does not appear to be any more severe than its original form, BA.1.

The WHO’s comments follow news that the new BA.2 strain is overtaking the original, more common Omicron BA.1 subvariant.

Dr Boris Pavlin, part of the WHO’s COVID-19 Response Team, said that the data so far demonstrates that there appears to be no difference in the virus’ severity and that BA.2 has the potential to replace BA.1 worldwide.

Pavlin said: “Vaccination is profoundly protective against severe disease, including Omicron. BA.2 is rapidly replacing BA.1.”

He noted that the subvariant is already emerging as a dominant strain in the Philippines, Nepal, Qatar, India and Denmark.

According to a Danish study analysing coronavirus infection cases in more than 8,500 Danish households between December and January, BA.2 is more transmissible than the common BA.1 strain, with the ability to infect vaccinated people.

Dr Susan Hopkins, chief medical advisor for UK Health Security Agency (UKHSA), said: “Ongoing variant analysis is an important part of our pandemic response. Thanks to the expertise of scientists at UKHSA and partner organisations, we’re able to respond quickly to new variations of the virus.”

Following advice from the Joint Committee on Vaccination and Immunisation (JCVI), people over 75 or those with suppressed immune systems are to be offered an additional COVID-19 booster dose this spring.

Until recently, only those with severely compromised immune systems had been eligible for a fourth dose – three doses and a booster. Another half a million people who are immunocompromised, living with conditions like blood cancer or have received an organ transplant or chemotherapy will also be eligible for the booster.

The JCVI said it was a “precautionary” move to vaccinate these groups and did not mean there was an immediate danger to their health. However, given that the people in these groups are at a substantially higher risk from COVID-19 and already have weaker immune systems than others who were vaccinated in autumn 2021, their protection provided by vaccines might be reduced.

Data has suggested that older people who have had two doses of a COVID-19 vaccine have about 45% protection against hospital admission with Omicron, but this rises to 90% straight after their first booster.

Older adults in residential care homes and those aged 12 and over with weakened immune systems will also be offered the second booster this spring, to be administered six months after their previous dose.

A record six million patients are on hospital waiting lists for non-urgent operations or procedures in England, as of November 2021. The need to suspend routine surgeries at times during the pandemic increased existing pressures on the health service.

The UK’s health and social care secretary Sajid Javid has commented on delays faced by NHS England in the face of tackling patient waiting-list backlogs.

Javid said that the number of patients on these hospital waiting lists would increase before beginning to fall, as an estimated eight to nine million people had stayed away from hospitals during the pandemic, although he also added it was difficult to know exactly how high the numbers would be.

On behalf of the government, a spokesperson said: “We are united in our plan to clear the NHS’s record backlog as we recover from the pandemic.”

As part of its plan to address the backlog, the government has released a new online service that allows people in need of non-urgent surgery or procedures to access information about NHS waiting times.

However, in an interview with the Today programme on BBC Radio 4, Matthew Taylor, chief executive of the NHS Confederation said “unrealistic” aims could result in “skewing clinical priorities”.

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Eli Lilly’s bebtelovimab, an antibody to treat the Omicron variant.

The EUA allows the drug to be used to treat adults with mild-to-moderate COVID-19, as well as children aged 12 or older, in specific emergency cases in non-hospital settings.
Patients must have had a positive SARS-CoV-2 viral test and be at high risk of developing severe COVID-19 that could lead to hospitalisation or death.

The FDA decision was based on results from the phase 2 BLAZE-4 clinical trial where non-hospitalised patients with mild-to-moderate COVID-19 either received bebtelovimab alone or a combination of bamlanivimab and etesevimab.

The trial showed that bebtelovimab retained full neutralising activity against Omicron, while also retaining neutralisation against all other known variants of concern, including the BA.2 strain.

Daniel Skovronsky, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, said: “With the emergence of variants such as Omicron, treatment options remain limited. [This is] another treatment option to help address the ongoing needs of patients and healthcare providers who continue to battle this pandemic.”

Lilly has an agreement with the US government to provide up to 600,000 doses of bebtelovimab.