Neumifil nasal spray heads to COPD Phase 2 trial with new investments

Phase 2b study of antiviral treatment expected to begin in 2024

by Lindsey Shapiro PhD | June 5, 2023

Pneumagen has secured £8 million (nearly $10 million) in investments to support the clinical development of its nasal spray, called Neumifil, for the prevention and treatment of virus-induced exacerbations in people with chronic obstructive pulmonary disease (COPD).

"We are very pleased to announce this funding from our existing and new investors," Douglas Thomson, CEO of Pneumagen, said in a company press release. "The funds will be used to support the continuing development of Neumifil, including preparing for a Phase 2b study in COPD patients which is planned to begin in 2024."

A recently-completed proof-of-concept Phase 2a trial (NCT05507567) assessed whether preventive treatment with Neumifil can block influenza infection among healthy adults. Results are expected in the coming months.

For patients with chronic lung diseases like COPD, respiratory viruses can be particularly harmful, driving acute worsening, or exacerbation, of existing symptoms.

Viral infections can lead to significant inflammation and breathlessness, resulting in hospitalization or other life-threatening consequences for patients. In the long term, repeated exacerbations also contribute to permanent declines in lung function.

Existing treatments for exacerbations include anti-inflammatory corticosteroids, but they have serious side effects with long-term use, and preventive antibiotics, which have limited efficacy against viral infections, according to Pneumagen.

Many common viruses are able to enter the body's cells by recognizing and binding to long sugar molecules called glycans on the cell's surface. In the case of respiratory viruses, they use these molecules to enter nasal cells, where they hijack cellular machinery to replicate and spread to other cells, including those in the lungs.

Self-administered directly into the nose via a spray, Neumifil is designed to stop a virus in its tracks in the nasal passages. It binds to sialic acids, the proteins found on the end of glycans that viruses interact with, as well as glycoproteins at the surface of certain viruses, such as SARS-CoV-2, the virus that causes COVID-19.

By doing so, Neumifil can stop the virus from entering cells, ultimately preventing infection.

The company believes this mechanism — which directly targets human cells instead of the virus itself — may prevent viruses from developing a resistance to the medication, a problem often observed with directly-acting anti-virals or vaccine therapies that can render them less effective.

Pneumagen is developing Neumifil as a broad-spectrum antiviral agent for the prevention and treatment of viral respiratory tract infections.

"Neumifil could address a large unmet medical need by preventing virus induced exacerbations, which can be potentially lethal for some patients suffering from serious underlying respiratory disease," said Mark Bamforth, founder of Thairm Bio, one of Pneumagen's existing investors.

Preclinical data have supported Neumifil's safety and efficacy against a range of common viruses, including influenza and SARS-CoV-2, when given either as a preventive approach or to treat an existing infection.

Single and multiple doses of the therapy were also found to be safe and well-tolerated in healthy volunteers in a Phase 1 trial (NCT05093530).

The Phase 2a trial enrolled 104 healthy adults, ages 18-55, at a single site in London. Participants were randomly assigned to receive single or multiple doses of Neumifil or a placebo before being exposed to the influenza virus.

Its main goal is to evaluate the effects of treatment on reducing the incidence and severity of influenza symptoms in the week after exposure. Safety, nasal discharge, presence of the virus in the bloodstream, and patient self-reported symptoms will also be assessed.

The upcoming Phase 2b trial will include COPD patients experiencing virus-induced disease exacerbations, and will evaluate the treatment's effects on exacerbation frequency.

"We are excited to make our initial investment in Pneumagen," said Dean Slagel, managing director at Esperante Ventures. "We were attracted by the quality of Pneumagen's leadership and multiple milestones that Douglas and the Pneumagen team have delivered as they work to position Neumifil as a treatment option for respiratory tract infections."