Study Shows Intranasal Chlorpheniramine Maleate Effective For the Treatment of COVID-19

Study sponsored by Dr. Ferrer BioPharma of Miami

MIAMI–(BUSINESS WIRE)–Today, The European Society of Medicine published a study, sponsored by Dr. Ferrer BioPharma of Miami, containing game-changing data on how the world can effectively reduce the effects of COVID-19. For more than two-years COVID-19 has been impacting our lives and today’s news could not come at a better time. This is especially true following the news earlier this week announcing the end of the travel mask mandate.

You can read the full study by clicking here: View of Intranasal Chlorpheniramine Maleate for the treatment of COVID-19: Translational and Clinical Evidence (esmed.org)

Despite vaccination campaigns and better treatments, COVID-19 remains a significant public health crisis worldwide. COVID-19 is a biphasic clinical syndrome characterized by an initial viremic phase (1-7 days) followed by a hypersensitivity-like hyperinflammatory state (> day 8) mainly driven by mast cell histamine degranulation, and ultimately acytokine storm 1-4. One of the primary treatment challenges is to apply effective therapies that can address both phases, particularly in the early stages of the disease, as the viral load is higher in the first week, with the highest peak occurring between days 4-6 after the onset of symptoms.

Recently, the nasal cavity has been highlighted as an ideal route of administration for interventions as it is the portal of entry of the severe acute respiratory syndrome coronavirus (SARS-CoV-2). The present study aimed to demonstrate the feasibility and efficacy of intranasally administered Chlorpheniramine Maleate (CPM) spray to treat coronavirus disease 2019 (COVID-19).

“We felt the need to test chlorpheniramine using the latest in vitro models of respiratory cells instead of commonly used models as SARS-CoV-2 enters via the nose. The drug showed effectiveness in vitro and on the clinical trial portion of the study. These findings represent another step towards identifying easy-to-apply treatments that could lead to fewer infections, faster recovery, and fewer hospitalizations. This in turn, could decrease the burden on healthcare systems owing to COVID-19,” said Dr. Sanchez-Gonzalez, VP & CSO of Dr. Ferrer BioPhrama and Adjunct Professor of Health Services Administration and Public Health at Lake Erie College of Osteopathic Medicine.

Methods: The present study used a two-phase, non-clinical to clinical approach. The non-clinical phase evaluated CPM’s antiviral activity against SARS-CoV-2 delta (B.1.617.2) strain via a highly differentiated three-dimensional in vitro model of normal, human-derived tracheal/bronchial epithelial cells. CPM was tested in duplicate inserts of the tissue models of the human airway. Virus yield reduction assays measured antiviral activity on day six after infection. For the clinical phase, COVID-19 symptomatic (polymerase chain reaction positive) patients were recruited and assigned to a 7-day CPM treatment (n=32) or placebo (PLB; n=13). Close safety monitoring of all patients was conducted before and after administering the drug. The primary outcomes monitored were time to symptom resolution (days), progression to hospitalization, emergency room visits, and symptoms of the severity of the disease using a visual analog scale (VAS) on a scale of 1-10 (no symptoms to worst symptoms).

Results: The virus yielded a reduction in the assay such that the CPM solution log reduction value was 2.69 and Remdesivir 0.12, demonstrating much high antiviral activity of CPM. Results of the clinical phase demonstrate that VAS scores between the groups were evident after using CPM for two days (day 3). The CPM group VAS were significantly lower (P<0.001) starting from day three compared with day one. In contrast, there were no statistically significant (P>0.05) changes in the PLB during the 7-day treatment window. No subjects in the intervention group were hospitalized, while two in the PLB required hospitalization (15.4%; X2=5.15, P=0.023). Besides some mild discomfort felt by subjects immediately after applying the spray, the participants reported neither adverse reactions nor side effects.

Conclusion: If taken together, the results of the present two-phase study point towards the conclusion that CPM is an antiviral agent that can be administered intranasally to treat COVID-19 effectively.

About Dr. Ferrer BioPharma

Dr. Ferrer BioPharma are the leading innovators in intranasal medications to treat cough, colds, flu, and allergies. Dr. Ferrer BioPharma uses advanced nanoparticle technology to bring high-quality, evidence-based, consumer-focused, and doctor-invented products to the market. The mission is to provide to the market evidence-based therapies combining new ideas with proven concepts in the service of helping people. From molecules to the delivery of effective therapies to treat the populations we serve, Dr. Ferrer BioPharma is designing top-of-the-line intranasal treatments to help people breathe better!

Contacts

Jeff Gulko

Dr. Ferrer BioPharma

617.304.7339

[email protected]