Cytodyn Inc (CYDY)

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SUMMARY HOUSTON: - AVIPTADIL EIND - 45 PATIENTS

All patients with comparable comorbidity from the same ICU, treated by the same clinical team, in the same time-frame who received maximal standard of care (SOC).

All patients had severe comorbidities that rendered them ineligible for the ongoing randomized controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19.

21 consecutively admitted patients with Critical COVID-19, treated with intravenous aviptadil (synthetic VIP), AND with maximal standard of care (SOC)

24 admitted patients with Critical COVID-19, treated with maximal standard of care (SOC)
Did not receive intravenous aviptadil.

HOUSTON EIND RESULTS AT 28 DAYS

Results: Nineteen of 21 patients survived to day 28 in the aviptadil-treated group compared to 4 of 24 control patients (90% vs 17%; P<.0001).

Kaplan-Meier analysis demonstrates a 9-fold advantage in probability of survival (Hazard Ratio 0.113; 95% CL 0.037, 0.343).

A similar 9-fold advantage was seen in cumulative probability of Recovery from Respiratory Failure (Hazard ratio: 0.115; 95% CL: 0.0254, 0.5219).

A mean 6.1 point difference in the 10 point WHO Ordinal Scale for COVID-19 was seen between aviptadil-treated patients, who exhibited a 2.6 point mean improvement from time of ICU admission vs. those treated with standard of care who exhibited a mean 3.5 point mean decrement (Wilcoxon rank sum: P<.001).

Improved radiographic appearance was seen in both lungs of 17 patients and in one lung of 2 treated patients.

Four of 5 aviptadil-treated patients initially on Extracorporeal Membrane Oxygenation (ECMO) have been decannulated, compared to 3 of 13 ECMO-treated controls (80% vs. 23%;P=.045). A 75% (95% CI±3%: P<.001) reduction in IL-6 was seen.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228


HOUSTON EIND RESULTS AT DAY 60

Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.

https://www.prnewswire.com/news-releases/neurorx-and-relief-announce-topline-efficacy-data-from-patients-treated-with-rlf-100-aviptadil-under-the-us-fda-expanded-access-protocol-authorization-for-respiratory-failure-related-to-critical-covid-19-301150707.html


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