RELEASE: Nasus Pharma Announces Publication of Positive Clinical Results With Epinephrine Intranase Powder Aerosol

Rapid and superior epinephrine uptake – for potentially faster rescue of patients in anaphylactic shock.

RELEASE: Nasus Pharma Announces Publication of Positive Clinical Results With Epinephrine Intranase Powder Aerosol

Rapid and superior epinephrine uptake – for potentially faster rescue of patients in anaphylactic shock

TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a portfolio of needle-free powder-based intranasal (PBI) products to address acute medical conditions, announced the publication of positive results from a clinical study of powder-based intranasal epinephrine.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is non-invasive, easy to use, and reliable, and could provide timely and effective rescue for life-threatening severe allergic reactions to food, medication, and insect bites . The clinical study provides further convincing evidence of the robustness of Nasus Pharma's intranasal powder technology already proven in other medicines. Importantly, the pharmacokinetics of powder-based intranasal epinephrine can potentially alleviate multiple concerns recently raised in the medical community regarding the adequacy of other intranasal solution-based epinephrines with respect to protection in the immediate post-development period. of anaphylactic shock.

"Nasus FMXIN002 intranasal epinephrine powder study results show that it may provide a safer and more effective rescue for emergency treatment of life-threatening allergic reactions by providing a compact, easy-to-use device and more rapid absorption of epinephrine." explained Dr. Dalia Meguido. CEO of Nasus Pharma. "Publication of our results in a leading scientific journal such as JACI: In Practice will ensure dissemination of the promise of FMXIN002 within the relevant medical community."

The FMXIN002 clinical study was a two-period, three-treatment, ascending-dose, open-label, comparative bioavailability study designed to compare the pharmacokinetic profile of FMXIN002 with the current standard of care: an intramuscular epinephrine auto-injector. (EpiPen®, Mylan)

Twelve (12) volunteers with known seasonal allergies received a three-sequence treatment with epinephrine 0.3 mg IM via autoinjector or FMXIN002 at doses of 1.6 and 3.2 mg. Each intranasal dosage was tested under normal conditions and under nasal allergen challenge where nasal congestion was created to simulate nasal congestion in anaphylaxis. The results demonstrate that the exposure (AUC) and peak plasma level (C) of a 3.2 mg dose of FMXIN002 was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. In addition, FMXIN002 showed a significantly superior pharmacokinetic profile, especially during the first 30 minutes under induced nasal congestions that occur in severe allergic reactions: C was doubled, compared to the IM autoinjector (1110 vs 551). AUC (0-8 h) was 56% higher (672 vs 431). Time to peak plasma level (T) and time to 100 pg/mL of a 3.2 mg dose of FMXIM001 was significantly faster than IM injection. Median T for IM injection was 9.0 minutes compared to 2.5 minutes for FMXIN002 3.2 mg under conditions of nasal congestion. The median time to 100 pg/mL was 3.0 minutes under normal conditions and 1.0 minutes under allergen challenge representing real life conditions of the nose in a severe allergic reaction to FMXIN002. The time to 100 pg/mL is considered to be the clinical threshold where pharmacodynamic responses begin to occur. These findings indicate that FMXIN002 may provide unprecedented rapid rescue with an easy-to-use, non-invasive device for life-threatening allergic reactions.

Treatment was well tolerated. There were no significant side effects or important changes in physiological parameters. Prof. Yuval Tal MD PhD, director of the Allergy and Clinical Immunology unit at Hadassah Medical Center, who led the study, added:

"In cases of severe, life-threatening allergic reactions, the therapeutic time window is very short and immediate epinephrine rescue is required. Therefore, the pharmacokinetics/pharmacodynamics of epinephrine rescue are extremely important. The lack of timely administration of epinephrine has been identified as the most important contributing factor to death from anaphylaxis Parents and caregivers are often hesitant to give injections Adolescents are reluctant to carry the bulky pack of two injections with them at all times and, sadly, they are overrepresented in cases of death.An easy-to-use pocket nasal inhaler could make the much-needed difference to rescue therapy of life-threatening allergic reactions.This, in addition to the significantly shorter time to reach therapeutic blood levels and the increased drug exposure in the critical first half hour, indicate that FMXIN002 could dramatically change the mortality risk associated with anaphylaxis."

This pilot study indicates that powder-based intranasal epinephrine may offer significant clinical advantages, compared to the currently available intramuscular route of drug delivery and other solution-based intranasal epinephrine programs under development. Powder based products are also known to have better stability, compared to solution based products. However, an added bonus to the powder formulation of epinephrine, a drug that undergoes rapid degradation in currently available short-life liquid dosage forms.

About FMXIN002

FMXIN002 is an epinephrine nasal spray powder formulation developed by Nasus Pharma based on its unique proprietary intranasal powder technology. The company believes that FMXIN002 may allow people to administer epinephrine in emergency situations easily, quickly, and with less worry, at the onset of an allergic reaction, compared to currently available epinephrine auto-injectors. FMXIN002 uses the APTAR Nasal Unidose Powder device, an intuitive and easy-to-use device with 360° functionality and precise single-dose nasal drug delivery.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes and, unless treated immediately, could be fatal. About 5 million people in the United States are at risk of having an anaphylaxis reaction. More than 200,000 emergency room visits due to severe food allergy reactions are reported annually.

About Nasus Pharma

Based on its unique microsphere technology, Nasus Pharma is developing a series of intranasal powder products intended to help patients in various acute emergency situations, such as opioid overdose and anaphylactic shock.

Intranasal administration is more suitable for those situations where rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. The Nasus portfolio comprises a number of programs: Intranasal Naloxone completed the pivotal study and Intranasal Epinephrine (Phase 2), as well as a number of preclinical POC programs.

Contact: Nasus Pharma Ltd. Israel


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