Summary of Two Sodium Pyruvate-Based Nasal Spray Clinical Trials Plus A Three Month At-Home Concentration-Preference Study

EmphyCorp Clinical Trials

Clinical Trial 1: Eighteen subjects who were regular nasal spray users were given EmphyClear™, a Sodium Pyruvate + Saline Nasal Spray to use at home two or three times a day for seven days, in place of their regular nasal spray. Several of these subjects regularly used saline, or OTC nasal products and several used steroid-based nasal sprays.

Prior to, and at the end of the study period, the subjects’ nostrils were examined for mucosal fragility, lesions, erythema, and edema using a rhinoscope. These pre- and post-study nasal characteristics were rated on a five point zero (“none”) to four (“severe”) scale, and compared.

Conclusions

All 18 subjects completed the study, and none opted to return to their normal nasal spray therapy during this period. The data obtained from the rhinoscopic examinations indicated that the Sodium Pyruvate + Saline Nasal Spray did not induce dermal irritation and was effective in significantly (p=0.006) reducing the erythema in subjects who normally use either saline or non-saline nasal sprays when pre-test ratings were compared to post-test ratings.

Further, subjective evaluations from the subjects indicated a positive preference for the Sodium Pyruvate + Saline Nasal Spray, with 83% of all subjects saying EmphyClear™ was “Better Than” or “Comparable To” their present therapy with regard to "Soothing;" and a like percentage of all subjects saying EmphyClear™ was “Better Than” their present therapy for relieving symptoms.

94% of all subjects said it was “Better Than” their present therapy with regard to less "Stinging." When questioned by the Investigator, 17 of 18 subjects stated that EmphyClear™ “Opened Nasal Passages,” and “Cleared Congestion.” These results were consistent whether the subject normally used a saline or steroid-based nasal spray.

Clinical Trial 2: Thirty-nine subjects who were regular nasal spray users due to chronic sinusitis or allergic rhinitis were recruited for this one week open label, in home-use trial. Six different Sodium Pyruvate + Saline combination nasal sprays, based on concentrations of saline and sodium pyruvate, were administered to the subjects, and each of the test products were used by at least six subjects. The subjects used the test nasal sprays at home (two to three sprays; two or three times a day) for seven days, in place of their regular nasal spray.

Prior to, and at the end of the study period, the subjects’ nostrils were examined for mucosal fragility, lesions, erythema, and edema using a rhinoscope.

Conclusions

Thirty-eight subjects completed the study. The data obtained from the rhinoscopic examinations indicated that none of the six test Sodium Pyruvate + Saline nasal spray test products induced nasal fragility, lesions, erythema, or edema.

81% of all subjects said the 0.45% sodium chloride + 2.2 mg/mL Sodium Pyruvate was “Better Than” or “Comparable” to their present therapy with regard to less "Stinging." When questioned by the Investigator, 35 of 39 (90%) subjects stated that the Pyruvate + Saline Nasal Sprays “Opened Nasal Passages,” and “Cleared/Reduced Congestion.” This product received an overall rating of 8.0, with all characteristic evaluations rated between 7.6 and 8.7 (“Likely to Buy”).

Consumer At-Home Trial: Three-Month Evaluation Study: 31 subjects that normally used nasal sprays were asked to evaluate the three different Sodium Pyruvate concentrations over a period of three months. The Sodium Pyruvate + Saline Nasal Sprays contained 0.45% saline + either 5mM, 10mM or 20mM Sodium Pyruvate. The subjects were asked to evaluate the three products in terms of congestive relief, and to indicate any preferences between the three concentrations of sodium pyruvate.

The 0.45% saline + 20 mM Sodium Pyruvate nasal spray was the preferred product with an overall rating of 90%. 29 out of the 31 subjects (94%) stated that this product “Opened Their Nasal Passages and Cleared their Congestion.”

Summary

In all, 88 patients were tested with six different Sodium Pyruvate formulae, and 81 patients (92%) regardless of formula saying that the Pyruvate + Saline Nasal Sprays opened their nasal passages and cleared their congestion for over 12 hours. In each study the Sodium Pyruvate + Saline Nasal Sprays were objectively and subjectively judged to be “Comparable To” or “Better Than” both Saline or Steroid-based commercial nasal sprays.