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The early termination of the NP-003 study is of great significance for reducing viral infections.

Tel Aviv, Israel, November 24, 2021 /PRNewswire/ - Nasus Pharma, a private clinical-stage biopharmaceutical company, develops a powder-based intranasal (PBI) product portfolio to respond to acute medical conditions and public health threats, announced today The data comes from its NP-003 study-a double-arm double-blind placebo-controlled study showed that the company’s innovative nasal powder inhaler Taffix® can effectively prevent the virus from reaching the nasal mucosa, significantly reducing the common cold and upper respiratory tract infections, and Shows a strong positive trend to reduce the risk of COVID infection.

The study included 521 unvaccinated healthy volunteers between the ages of 18-65 who tested negative for the antibody COVID when they entered the study. After randomization, volunteers were followed up twice a week for 6 weeks to observe symptoms consistent with upper respiratory tract infections and the common cold. Symptoms compatible with clinical COVID led to PCR testing throughout the study.

At the end of the study visit, all volunteers were tested for antibodies again, and if they were positive, they were verified by an additional SARS-CoV 2 PCR test. Carry out pre-planned mid-term analysis according to the plan.  

517 volunteers completed the study period. There were 260 people in the treatment group and 257 people in the placebo group.

Compared with the treatment group, more participants in the placebo group complained of symptoms consistent with upper respiratory infections, such as runny nose, cough, shortness of breath, and dyspnea: there were 67 complaints in the placebo group compared to 38 in the treatment group . The difference between the Taffix® group and the placebo group is highly statistically significant (Poisson test = 0.002).

Throughout the study, 19 (7.3%) participants from the treatment group and 29 (11.3%) participants from the placebo group were diagnosed with COVID. The odds ratio is 0.6198. Due to the relatively small number of subjects, statistical significance has not yet been reached (Fisher's exact test-0.079), proving a strong positive trend in the reduction of COVID infections

According to the stopping rules of each agreement, Nasus management decided to terminate the study early. Volunteers in the study cannot be vaccinated during the study period. Although the general healthy population in Bulgaria could not get vaccinations for free earlier this year-this is no longer the case, and Nasus’ management decided to continue recruiting volunteers to participate in a study that ruled out their ability to vaccinate is unethical.

"The results of the interim analysis show that the reduction in symptoms of the common cold and upper respiratory tract infection is highly statistically significant, and has a consistent and positive trend in blocking COVID." commented Dr. Dalia Megiddo, CEO of Nasus Pharma . "These results, together with other laboratory and clinical studies we published earlier this year [1] [2] [3], demonstrate the robustness of the scientific evidence supporting Taffix's ability to block nasal viruses and prevent viruses. Viral infections .

Udi Gilboa, Executive Chairman of Nasus Pharma’s Board of Directors, added: “We are very satisfied with the results of the trial. This promising, statistically significant clinical data provides a solid foundation for the clinical and medical properties of Taffix ® and strengthens Taffix ® The potential to become the preferred product for upper respiratory virus protection. We intend to further accelerate and expand Taffix®, commercial presence and availability, while simplifying our supply chain capabilities to support the growing global demand for Taffix®.

Taffix® is currently approved for sale in Europe, Canada, Israel and many South American, Asian, African and Middle Eastern countries/regions as a protective mechanical barrier against allergens and viruses in the nasal cavity. Its development purpose is to create a hostile in the nose Microenvironment. Proven to prevent viruses from entering and infecting nasal cells. Taffix®, the powder forms a unique thin, acidified gel on the nasal mucosa within 50 seconds for 5 hours, which significantly protects nasal cells from inhaled viruses.

Based on its unique microsphere technology, Nasus Pharma is developing a variety of intranasal powder products designed to help patients cope with a variety of acute emergencies, such as opioid overdose and anaphylactic shock.

Intranasal administration is most suitable for occasions that require rapid administration, and has multiple advantages such as rapid administration, convenient use, non-invasive, and safety. The Nasus product portfolio includes multiple projects: intranasal naloxone (after phase 3) and intranasal adrenaline (phase 2), as well as many preclinical POC projects.

[1] Klang Shmuel, Megiddo Dalia, Lapidot Tair, and Naparstek Yaakov (2021) Low pH hypromellose (Taffix) nasal spray can reduce the SARS-CoV-2 infection rate after a large-scale clustering event in a highly prevalent community: an observation Prospective open label user survey, expert review of anti-infective treatment, DOI: 10.1080/14787210.2021.1908127

[2] Barbara J Mann, G Brett Moreau, Tair Lapidot, Dalia Megiddo. TaffiX® nasal powder forms an effective barrier against SARS-CoV-2. Biomedical J Sci & Tech Res 33(3)-2021. BJSTR. MS.ID.005405.

[3] Michal Mandelboim, Ella Mendelson, Yaron Drori, Nofar Atari, Tair Lapidot, Dalia Megiddo, Micha Gladnikoff. Taffix® nasal powder spray forms an effective barrier against new infectious variants of SARS-Cov-2 (Alpha, Beta and Delta). Archives of Clinical and Biomedical Research 5 (2021): 794-802.

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