Nasus Pharma Ltd.

Nasus Powder Epinephrine offers long term stability as well as rapid and higher epinephrine absorption- changing the face of anaphylactic shock treatment TEL AVIV, Israel, Aug. 6, 2024 /PRNewswire/ -- Nasus Pharma Ltd , a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the results of a 5 years stability study of its FMXIN002 drug candidate – nasal powder epinephrine for the treatment of severe allergy and anaphylactic shock. FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly, and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications, and insect bites. FMXIN002 stored 5-year at room temperature (15-25° Celsius) showed full stability of the nasal powder and device. Epinephrine base was 97.5% at 5 years well within the defined limits (95-105% ICHQ1). The levels of degradation products were 0.37% which is significantly below the maximum level of 4 % defined for the low-dose (<10 mg) producta. In addition, the enantiomeric purity was found to be 100%,. These results are in line with prior results of FMXIN002 showing full stability after 6 months in accelerated conditions (40° Celsius and 75% humidity). These findings are also in line with a prior study that compared FMXIN002 with Epipen autoinjectors showing 100% Epinephrine enantiomeric purity in FMXIN002 vs 1.9% S-Epinephrine impurity found in Epipen injector ( below allowed level of 3%) and 3.8 % of S-Epinephrine impurity found in Junior Epipen injectors (above allowed level). Both autoinjectors were still prior to their expiration date. Epinephrine, the mainstay of immediate treatment for severe allergy and anaphylaxis is known to be unstable in liquid form requiring the addition of multiple excipients and stabilizers some of which may be associated with added safety concerns. Epinephrine in solution carries between 12-18 months expiration dates. FMXIN002 is a proprietary powder dosage form that requires no stabilizers and offers extremely long stability period and excellent safety profile. The long stability of Epinephrine carries meaningful advantages both for patients (currently need to replace injectors on average every 12 months) and healthcare payors given the high costs of Epinephrine autoinjectors. Additionally, the stability of FMXIN002 under extreme conditions of heat and humidity enables carrying the FMXIN002 inhaler during daily activities and avoiding the need to shield the inhaler from heat and humidity. Lately, Nasus Pharma published the results of its phase 2 clinical study demonstrating the clear advantage of its FMXIN002 inhaler in creating quicker and higher levels of Epinephrine in the blood compared to Epipen autoinjector, especially in the first 30 minutes – when prompt treatment in Epinephrine is critical. Importantly the pharmacokinetics of the powder-based intranasal epinephrine were able to abate multiple concerns recently raised within the medical community as to the adequacy of other albeit solution-based nasal epinephrine products in development with regards to the protection in the immediate period following the development of anaphylactic shock: FMXIN002 demonstrated clear and meaningful advantage both in the pharmacokinetic profile of the first 20-30 minutes and in the number of patients reaching drug plasma clinical threshold of Epinephrine. (91% in the first 6 minutes). "The results of our long-term stability study as well as the results from our phase 2 clinical study are further confirmation of the advantages of our proprietary powder intranasal epinephrine FMXIN002 in offering easy to use reliable small device that can be carried around in a small pocket and is a highly effective immediate treatment for anaphylactic shock" - Said Dr. Dalia Megiddo, Nasus Pharma CEO. Udi Gilboa, Executive Chairman of the Board added: "We are extremely encouraged by the data generated by the company up-until today including the latest outstanding results showing unheard of Epinephrine stability of 5 years. The commercial potential of our Powder-Based Epinephrine product and its potential to become the fastest-acting simple-to-administer, needle-free nasal spray, provides patients and caregivers with the most promising alternative for this growing Type I allergic reaction market. The stability of our FMX002 powder inhaler is financially meaningful as the current alternatives in the market of solution-based Epinephrine have only 12–18-month stability. Powder-based products are also known to have better stability, as compared to solution-based products. Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently available short shelf-life liquid dosage forms." About FMXIN002 FMXIN002 is a 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. Contact: [email protected] Nasus Pharma Ltd. Israel Logo: SOURCE Nasus Pharma

Rapid and higher epinephrine absorption- for potentially quicker rescue of patients in anaphylactic shock TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine. Nasus Pharma recently completed an additional phase 2 study (NP-006-Epinephrine) confirming the superiority and safety of its lead FMXIN002 Intranasal Epinephrine product. FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites. The recent clinical study explored the safety and efficacy of FMXIN002 in its intended clinical dose and provided additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology already tested in a prior pilot study ( Tal, et al. The Journal of Allergy and Clinical Immunology: In Practice 11.10 (2023).). Importantly the pharmacokinetics of the powder-based intranasal epinephrine were able to abate multiple concerns recently raised within the medical community as to the adequacy of other albeit solution-based epinephrine products in development with regards to the protection in the immediate period following anaphylactic shock development: FMXIN002 demonstrated clear and meaningful advantage both in the pharmacokinetic profile of the first 20 minutes and in the number of patients reaching drug plasma clinical threshold of Epinephrine. "The results of NP-006-Epinephrine study are further confirmation of the advantages of our powder intranasal epinephrine in covering the immediate period of anaphylactic shock- both in creating higher levels of Epinephrine in the blood quicker and in creating clinically meaningful epinephrine levels in significantly more patients. FMXIMIN002 can potentially be more effective rescue for the emergency treatment of life-threatening allergic reactions by providing a compact easy-to-use, needle-free device and quicker absorption of Epinephrine," said Dr. Dalia Megiddo, Nasus Pharma CEO. NP-006-Epinephrine study was an open-label, ascending dose, three-period, three-treatment, comparative bioavailability study designed to compare the PK profile ascending doses ( 3.6 and 4mg) of FMXIN002 nasal spray with the current standard of care - an intramuscular epinephrine autoinjector. (EpiPen®, Mylan ) Twelve (12) healthy volunteers received 0.3 mg IM epinephrine via an autoinjector or FMXIN002 and 3.6 mg and 4.0 mg intranasally in weekly intervals. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of both FMXIN002 dosages were comparable to that of 0.3 mg IM injection of epinephrine however a meaningful advantage of intranasal administration was demonstrated at all timepoints up to 30 minutes both in the plasma drug levels and in the number of patients reaching clinical threshold of the drug in the plasma. The exposure at first 4 minutes was significantly higher after FMXIN002 4.0 mg nasal spray compared to EpiPen (AUC0-4). Epinephrine mean plasma levels after 4.0 mg Intranasal at 4 minutes were 5 times higher compared to Epinephrine (27.4 h*pg/ml vs 5.8 h*pg/ml) (p-0.0377). Epinephrine plasma levels after 4.0 mg Intranasal at 10 minutes were 2.3 times higher compared to Epinephrine (64.0h*pg/ml vs 27.4 h*pg/ml) and 160% higher at 20 minutes (111.4 h*pg/ml vs 71 h*pg/ml). Six minutes after dosing FMXIN002 4.0mg nasal spray, 91% of the subjects reached the clinical threshold of 100pg/m plasma epinephrine, while only 55% achieved this threshold after EpiPen administration. The level of 100 pg/mL plasma epinephrine is considered to be the clinical threshold where pharmacodynamic responses begins to occur when treating anaphylaxis. These findings indicate that FMXIN002 can provide an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions. The treatment was well tolerated. There were no significant side effects and no significant changes in physiological parameters. The pharmacodynamic response was comparable to that of EpiPen. Prof. Yoseph Caraco, the principal investigator at Hadassah medical center added: "In cases of severe life-threatening allergic reaction, the therapeutic time window is very short and immediate rescue with epinephrine is critically required. To ensure immediate response the pharmacokinetics /pharmacodynamics of epinephrine rescue are extremely important. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death from anaphylaxis. Parents and care givers are often hesitant to give injections. Teenagers are averse to carry the bulky two injection package with them at all times and are sadly over-represented in fatality cases. A pocket-size user-friendly nasal inhaler could potentially be the perfect solution for rescue therapy of life-threatening allergic reactions. In addition, the significantly shorter time to therapeutic blood levels and the higher drug exposure in the critical first half an hour imply that FMXIN002 could potentially change the fatality risk associated with anaphylaxis." Udi Gilboa, Executive Chairman of the Board added: "We are extremely encouraged by the data generated by the company up-until today including in this dose-response Phase II trial. The commercial potential of our Powder-Based Epinephrine product and its potential to become the fastest-acting simple-to-administer, needle-free nasal spray, provides patients and caregivers with the most promising alternative for this growing Type I allergic reaction market. The safety and fastest-response profiles of our needle-free product combined with the stability of our powder-based platform also provides payers with significant potential to expand the usage of epinephrine for severe allergic reactions. "This phase 2 study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development. Powder-based products are also known to have better stability, as compared to the solution-based products. Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms." About FMXIN002 FMXIN002 is a 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. Contact: [email protected] Nasus Pharma Ltd. Israel Logo: SOURCE Nasus Pharma

Rapid and higher epinephrine absorption - for potentially quicker rescue of patients in anaphylactic shock TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the publication of positive results from a clinical study 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 clinical study provides additional compelling evidence to the robustness of Nasus Pharma's intranasal powder technology already tested in other drugs. Importantly the pharmacokinetics of the powder-based intranasal epinephrine can potentially abate multiple concerns recently raised within the medical community as to the adequacy of other intranasal solution-based epinephrine with regards to protection in the immediate period following anaphylactic shock development. "The results of Nasus's FMXIN002 powder intranasal epinephrine study show that it can provide a safer and more effective rescue for the emergency treatment of life-threatening allergic reactions by providing a compact easy-to-use device and quicker absorption of Epinephrine," said Dr. Dalia Megiddo. Nasus Pharma CEO. "The publication of our results in a prominent scientific journal such as JACI: In Practice will ensure the dissemination of FMXIN002's promise within the relevant medical community." The FMXIN002 clinical study was an open-label, ascending 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. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of a 3.2 mg FMXIN002 dose was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. Moreover FMXIN002 showed a significantly superior PK profile especially during the first 30 minutes under induced nasal congestions that occurs in severe allergic reactions: Cmax was double, compared to IM autoinjector (1110 vs. 551). AUC (0-8h ) was 56% higher (672 vs. 431). The time to maximum plasma level (Tmax) and time to 100 pg/mL of a 3.2 mg FMXIM001 dose was significantly faster than IM injection. Median T max for IM injection was 9.0 minutes compared to 2.5 minutes for 3.2 mg FMXIN002 under nasal congestion conditions. Median Time to 100 pg/mL was 3.0 minutes under normal conditions and 1.0 minutes under allergenic challenge that represents the real-life conditions of the nose in severe allergic reaction for FMXIN002. The time to 100 pg/mL is considered to be the clinical threshold where pharmacodynamic responses begins to occur. These findings indicate that FMXIN002 can provide an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions. The treatment was well tolerated. There were no significant side effects and no significant changes physiological parameters. Prof Yuval Tal MD PhD, Director of Allergy and Clinical Immunology unit at Hadassah Medical Center who headed the study added: "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. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death from anaphylaxis. Parents and care givers are often hesitant to give injections. Teenagers are averse to carry the bulky two injection package with them at all times and are sadly over-represented in fatality cases. A pocket-size user-friendly nasal inhaler could make the much-needed difference sorely needed for rescue therapy of life-threatening allergic reactions. This, in addition to the significantly shorter time to therapeutic blood levels and higher drug exposure in the critical first half an hour indicate that FMXIN002 could change dramatically the fatality risk associated with anaphylaxis." This pilot study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development. Powder-based products are also known to have better stability, as compared to the solution-based products. Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms. About FMXIN002 FMXIN002 is a 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. Contact: [email protected] Nasus Pharma Ltd. Israel Logo: SOURCE Nasus Pharma