Nasus Pharma Announces Positive Results from a Pilot Clinical Study of FMXIN002 Intranasal Powder Epinephrine Spray in Patients with Seasonal Allergic Rhinitis

Results demonstrate rapid epinephrine absorption- for potentially quicker rescue of patients in anaphylactic shock

TEL AVIV, Israel, June 23, 2021 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) specialized product portfolio, to address acute medical conditions announced positive results from a pilot trial of intranasal powder-based Epinephrine.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites. The pilot study is the first human study for powder Epinephrine and provides additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology in addition to the recently published results of its intranasal Naloxone pivotal study.

"The results of the study with FMXIN002 powder intranasal Epinephrine show that it can provide a safer and more effective rescue for the emergency treatment of life-threatening allergic reactions by providing an easy-to-use device and quicker absorption of Epinephrine," said Dr. Dalia Megiddo, Nasus Pharma CEO.

The FMXIN002 pilot study was an open-label, ascending single dose, two-period, three-treatment, comparative bioavailability study designed to compare the PK profile of FMXIN002 with the current standard of care- an intramuscular epinephrine autoinjector. (EpiPen^®, Mylan)

Twelve (12) volunteers with known seasonal allergies received three-sequenced treatment with either 0.3 mg IM epinephrine via an autoinjector or FMXIN002 in dosages of 1.6 and 3.2 mg. Each intranasal dosage was tested under normal conditions and under nasal allergen challenge in which nasal congestion was created to simulate the congestion of the nose in anaphylaxis. All in all, five treatments were given in a cross-over design to compare the PK/PD response to epinephrine delivered by FMXIN002 or injection with and without a nasal allergen challenge.

The results demonstrate that the exposure (AUC_0-t) and maximum plasma level (C_max) of a 3.2 mg FMXIN002 dose was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. The time to maximum plasma level (t_max) and time to 100 pg/mL of a 3.2 mg FMXIM001 dose was significantly faster than IM injection.  Time to 100 pg/mL was 10.2 minutes under normal conditions and 1.2 minutes under allergenic challenge that represents the real-life conditions of the nose in severe allergic reaction for FMXIN002 . T _max for IM injection was 19.8 minutes. The time to 100 pg/mL is considered to be the clinical threshold where pharmacodynamic responses begin to occur.

FMXIN002 showed significantly superior PK profile especially during the first 30 minutes in a simulation of the real-life nasal congestions that occurs in severe allergic reactions: C_max was double, compared to IM autoinjector (1110 vs. 551). AUC _{(0-8h )} was 56% higher (672 vs. 431) and T_max was significantly shorter (2.0 min vs. 19.8 min) .

These finding combined with the significantly shorter time to reach the therapeutic clinical threshold of 100 pg/mL indicate that FMXIN002 can provides an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions.

The treatment was well tolerated with no significant side effects and there were no excess changes physiological parameters.

Dr. Dalia Megiddo, Nasus Pharma CEO, said: "In cases of severe life-threatening allergic reaction the therapeutic time window is very short and immediate rescue with Epinephrine is required. Therefore, the pharmacokinetics /pharmacodynamics of epinephrine rescue are extremely important for this immediate period. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death in patients with allergies. Parents and care givers  are  often reluctant to give injections. A user-friendly simple nasal inhaler could make the much-needed rescue therapy be given in time. This, in addition to the significantly shorter time to therapeutic blood levels and higher dose in the relevant first half an hour FMXIN002 could change dramatically the risks associated with severe allergy and anaphylaxis".

Udi Gilboa Nasus Pharma active chairman of Nasus  board added: It is well established that powder nasal drugs enjoy better bioavailability, quicker absorption and better stability compared to fluid nasal formulations. Nasus Pharma's robust intranasal powder technology is proven again to deliver significantly quicker higher doses of rescue therapy in cases of medical emergencies where immediate therapy is needed. As with our Naloxone program now heading towards NDA, Nasus Pharm will continue to move forward with its development programs in collaboration with the regulatory authorities and with its pre-commercialization efforts with all stake-holders. 

Prof. David Stepensky, Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Israel

Timely administration of epinephrine in cases of severe allergy and anaphylaxis is imperative in these life-threatening situations. The findings of this pilot study indicate that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration. Powder-based products are  also known to have better stability, as compared to the solution-based products. This could offer an additional advantage for powder-based formulation of adrenaline, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.

About FMXIN002

FMXIN002 is an powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 may enable people to deliver epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. FMXIN002 uses APTAR Nasal Unidose Powder device – an intuitive and easy-to-use device with 360° functionality and precise one-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 promptly could be fatal. Some 5 million people in the United States are at risk of having an anaphylaxis reaction. Over 200,000 emergency room visits due to severe reactions from food allergies are reported annually.

About Nasus Pharma
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 completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

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Contact:

Info@nasuspharma.com 
Nasus Pharma Ltd. Israel 
https://www.nasuspharma.com

SOURCE Nasus Pharma