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Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder

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Interim results indicate NS002 demonstrated significantly faster absorption and higher peak epinephr...

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AI Summary

Nasus Pharma's NS002 demonstrated significantly faster absorption and peak levels than EpiPen® in a recent trial. With no serious adverse events reported, the interim results support NS002's promise in anaphylaxis treatment, prompting further studies set for late 2026.

Sentiment Rationale

Positive interim results could bolster investor confidence and valuation. Historically, similar announcements have led to substantial price increases for biopharma firms.

Trading Thesis

Invest in NSRX for potential price appreciation ahead of Phase 2 results in Q1 2026.

Market-Moving

  • High efficacy demonstrated in NS002 could significantly enhance market valuation of NSRX.
  • Initiation of pivotal study in Q4 2026 may trigger more investor interest.
  • Positive interim results could lead to increased analyst upgrades and coverage.

Key Facts

  • NS002 shows faster absorption than EpiPen® in recent trial.
  • 91% of NS002 users reached critical plasma threshold within 5 minutes.
  • NS002 demonstrated safety with no serious adverse events reported.
  • Pivotal clinical study of NS002 planned for Q4 2026.
  • Full Phase 2 results expected by Q1 2026.

Companies Mentioned

  • EpiPen (NA): EpiPen is the market leader in epinephrine autoinjectors potentially threatened by NS002.
  • Nasus Pharma (NSRX): Positive clinical results position NSRX favorably against competitors.

Research Analysis

The content falls under 'Research Analysis,' highlighting significant interim clinical results that could impact NSRX's market position in the anaphylaxis treatment space. The promising findings can attract attention from investors and healthcare professionals alike, reinforcing the company's growth potential.

Nasus Pharma Reports Promising Interim Results from NS002 Phase 2 Clinical Study

Nasus Pharma Ltd. (NYSE: NSRX), a clinical-stage pharmaceutical company focused on innovative intranasal treatments for emergency medical conditions, has announced positive interim results from its Phase 2 clinical study of NS002, an investigational intranasal epinephrine powder formulation designed for the treatment of anaphylaxis.

The interim analysis reveals that NS002 significantly outperformed the traditional intramuscular EpiPen® in terms of absorption speed and peak epinephrine levels. Notably, 91% of participants administered NS002 reached the plasma epinephrine threshold of 100 pg/ml at just 5 minutes post-dosing, compared to 67% for EpiPen®.

Study Overview and Design

The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis, divided into two cohorts.

  • The first cohort included 25 participants who received either NS002 or EpiPen® with or without a nasal allergic challenge.
  • The second cohort also comprised 25 participants who received repeat doses of NS002 or EpiPen® under similar conditions, simulating real-world instances where multiple administrations may be required.

The final analysis will evaluate results from all 50 subjects who completed the treatment arms.

Key Interim Results

The interim results for NS002 highlight several important findings:

  • Mean peak plasma concentration (Cmax) for NS002 was recorded at 655 pg/ml, exceeding the 548 pg/ml observed with EpiPen®.
  • NS002 achieved peak concentration (Tmax) in an average of 10.8 minutes as opposed to 15 minutes for EpiPen®.
  • Total epinephrine absorption in the critical first 10 minutes was higher for NS002 with an area under the curve (AUC) of 55 h*pg/ml, compared to 32 h*pg/ml for EpiPen®.

Safety and Tolerability

NS002 demonstrated a favorable safety profile, being well-tolerated with no serious adverse events reported. Of the treatment-emergent adverse events, 95% were mild and resolved on their own, primarily localized effects. The pharmacodynamic responses remained stable and comparable to EpiPen®, with vital signs within normal ranges.

Expert Insights on NS002

Dr. Michael Blaiss, Clinical Professor of Allergy and Immunology and a member of Nasus Pharma's Scientific Advisory Board, stated, “These interim results are highly encouraging and reinforce the potential of NS002 as a meaningful advancement in anaphylaxis treatment... Delays in achieving effective pharmacologic action are associated with increased mortality.”

CEO Dan Teleman echoed this sentiment, stating, “We are extremely pleased with these positive interim results, which we believe further validate NS002's potential... We look forward to completing the Phase 2 study and advancing to our pivotal clinical program.”

Future Plans for NSRX

Nasus Pharma anticipates completing the Phase 2 study by the end of the first quarter of 2026, with plans to initiate a pivotal clinical study in the fourth quarter of 2026. This progress is pivotal as the company aims to position NS002 as a first-in-class intranasal epinephrine product for severe allergies.

About Nasus Pharma

Nasus Pharma is dedicated to developing intranasal powder products targeting acute medical conditions. NS002 represents an innovative, needle-free alternative to traditional epinephrine autoinjectors for anaphylaxis treatment, leveraging its proprietary powder-based intranasal technology to ensure rapid and effective drug delivery.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of U.S. federal securities laws, anticipated developments, and future performance. For more information, please refer to the company’s prospectus filed with the U.S. Securities and Exchange Commission.

Contact Information

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