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NP-003 study terminated early with high significance in reducing viral infection.

TEL AVIV , Israel , Nov. 24, 2021 /PRNewswire/ -- Nasus Pharma a privately held clinical-stage biopharmaceutical company developing a powder-based intranasal (PBI) product portfolio to address acute medical conditions and public health threats, today announced data from its NP-003 study  -a two arm double blind placebo controlled study  demonstrating that  Taffix®, the Company's innovative nasal powder inhaler that effectively blocks viruses from reaching nasal mucosa, was able to significantly reduce Common Cold and Upper Respiratory Infection and showed a strong positive trend in reducing the risk of COVID infection.

The study included 521 unvaccinated healthy volunteers between the ages of 18-65 that had a negative antibody COVID test at admission to the study. After randomization the volunteers were followed for 6 weeks twice a week for symptoms compatible with Upper Respiratory Infection and Common Cold. Symptoms compatible with clinical COVID led to PCR testing throughout the study.

At the end of study visit, all volunteers were again tested with antibody test and if positive- were verified by additional  SARS-CoV 2 PCR testing. A pre-planned interim analysis was conducted per protocol.  

517 volunteers completed the study period. 260 in the treatment arm and 257 in the placebo arm.

More participants in the placebo group complained of symptoms compatible with Upper Respiratory Infections such as runny nose, cough, shortness of breath and breathing difficulties compared to the treatment group:  A total of 67 complaints among the placebo arm vs 38 in the treatment arm participants.  The difference between the Taffix®,  group and the placebo groups was highly statistically significant ( Poisson test = 0.002).

Nineteen  (7.3 %) participants from the treatment arm and twenty nine( 11.3 %) from the placebo group were diagnosed with COVID throughout the study. Odds ratio was 0.6198. A strong positive trend of reduced COVID infection was demonstrated that due to the relatively small number of subjects did not yet reach statistical significance (Fisher exact test - 0.079)

Based on a per protocol stop rules, Nasus management decided to bring the study to an early termination. Volunteers in the study could not be vaccinated during their participation in the study. While earlier this year vaccination was not freely available to the general healthy population in Bulgaria - that is no longer the case and Nasus management decided that it is unethical to continue and recruit volunteers to a study that precludes their ability to be vaccinated.

"The results of the interim analysis show highly statistical significance reduction of Common Cold and Upper Respiratory Infection symptoms and a consistent and positive trend of efficacy in blocking COVID."  commented Dr. Dalia Megiddo Chief Executive Officer of Nasus Pharma. "These results , added to the additional laboratory and clinical studies  we have published[1]  [2]  [3] earlier this year, demonstrate the robustness of the scientific evidence that supports Taffix 's ability to block viruses in the nasal cavity and prevent viral infections.

Udi Gilboa , Executive Chairman of the Board of Nasus Pharma added, "We are very pleased with the trial results. This promising, statistically significant clinical data provides a strong foundation for Taffix®, ' clinical and medical attributes and reinforces the potential of Taffix®,  to become a leading product-of-choice for Upper Respiratory virus protection.  We intend to further accelerate and expand Taffix®, commercial presence and availability while streamlining our supply chain capabilities to support the global growing demand for Taffix®, .

Taffix®, currently approved for marketing as a protective mechanical barrier against allergens and viruses  within the nasal cavity in Europe , Canada, Israel and  multiple South America , Asia , Africa and Middle East countries was developed to create a hostile microenvironment in the nose which is proven to prevent viruses from entering and infecting nasal cells. Taffix®, powder creates within 50 seconds a unique thin acidified gel above the nasal mucosa that lasts 5 hours, significantly shielding the nasal cells from inhaled viruses.

Based on its unique microsphere technology Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock.

Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs: Intranasal Naloxone (post phase 3 ) and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

[1] Klang Shmuel , Megiddo Dalia, Lapidot Tair & Naparstek Yaakov (2021) Low pH Hypromellose (Taffix) nasal powder spray could reduce SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: an observational prospective open label user survey, Expert Review of Anti-infective Therapy, 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. Biomed 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 Infectious New Variants of SARS-Cov-2 (Alpha, Beta and Delta). Archives of Clinical and Biomedical Research 5 (2021): 794-802.

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