TNX-102 SL
Fibromyalgia, Long COVID & PTSD
NASDAQ: TNXP
Version P0404 January 4, 2023 (Doc 1147)
© 2022 Tonix Pharmaceuticals Holding Corp.
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© 2022 Tonix Pharmaceuticals Holding Corp.
TNX-102 SL*: Fibromyalgia
Cyclobenzaprine Protectic® Sublingual Tablets
PROFILE | DEVELOPMENT PROGRAM |
Fibromyalgia (FM) is a chronic pain disorder resulting | Market Entry: Fibromyalgia |
from amplified sensory and pain signaling within the CNS | |
• Afflicts an estimated 6-12 million adults in the U.S., approximately | Additional Indications: Long COVID, PTSD, |
Agitation in Alzheimer's, Alcohol Use Disorder | |
90% of whom are women1 | |
CNS PORTFOLIO
- Symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction
- Patients struggle with daily activities, have impaired quality of life, and frequently are disabled
- Physicians and patients report common dissatisfaction with currently marketed products
When the check engine light malfunctions, the light is on even though the car is not malfunctioning
Patents Issued
Status: One Positive Phase 3 study RELIEF completed
Second Phase 3 study RALLY missed primary endpoint
Confirmatory Phase 3 study RESILIENT is currently enrolling
Next Steps: Interim analysis results expected 2Q 2023
*TNX-102 SL has not been approved for any indication.
1American Chronic Pain Association (www.theacpa.org, 2019)
© 2022 Tonix Pharmaceuticals Holding Corp.
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TNX-102 SL: Fibromyalgia
Program Update
Phase 3 Study, RESILIENT, will compare TNX-102 SL 5.6 mg and placebo
- First patient enrolled in April 2022
- Interim Analysis results expected 2Q 2023
- Parallel design, double-blind, randomized placebo-controlled study, all U.S. sites
- Primary endpoint is pain at Week 14 analyzed by MMRM with MI
- Projecting adverse event-related discontinuations to decrease towards rates in RELIEF and PTSD Studies
Phase 3 Study, RALLY, comparison of TNX-102 SL 5.6 mg and placebo
- As expected from interim analysis results published in July 2021, RALLY Study missed primary endpoint
- Unexpected ~80% increase in adverse event-related discontinuations in both drug and placebo arms
- Multiple imputation approach on 'Missing Data' attenuated statistical significance of efficacy endpoints'
- TNX-102SL was generally well tolerated with overall adverse event profile comparable to prior studies; no new safety signals observed
CNS PORTFOLIO
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© 2022 Tonix Pharmaceuticals Holding Corp.
TNX-102 SL: RALLY Study
Increased Adverse Event-Related Discontinuations
Increases in AE-Related discontinuations in RALLY study compared with RELIEF study in both placebo and TNX-102 SL groups
RALLY (F306) | RELIEF (F304) | RALLY (F306) | RELIEF (F304) | |||
Placebo | TNX-102 SL | |||||
Patients with at least one TEAE leading | 6.2% | 3.5% | 15.2% | 8.5% | ||
to early discontinuation | ||||||
Ratio of patients with at least one TEAE | ||||||
leading to early discontinuation in F306 | 1.77 | 1.79 | ||||
to F304 (F306/F304) | ||||||
TEAE = treatment-emergent adverse event |
Adverse events in RALLY
- TNX-102SL 5.6 mg was well tolerated.
- Among participants randomized to drug and placebo groups, 73.8% and 81.4%, respectively, completed the 14-week dosing period.
- As expected, based on prior TNX-102 SL studies, oral administration site reactions were higher in the drug treatment group, including rates of tongue/mouth numbness, pain/discomfort of tongue/mouth, and product taste abnormal (typically a transient bitter aftertaste)
- Tongue/mouth numbness or tingling and product aftertaste were local effects nearly always temporally related to dose administration and transiently expressed (<60 minutes) in most occurrences.
- Adverse events resulted in premature study discontinuation in TNX-102 SL and placebo groups at rates of 15.2% and 6.2%, respectively
• Approximately 95% of adverse events in both the drug treatment and placebo groups were rated as mild or moderate.
© 2022 Tonix Pharmaceuticals Holding Corp.
CNS PORTFOLIO
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Tonix Pharmaceuticals Holding Corp. published this content on 04 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 January 2023 14:07:03 UTC.