Tonix Pharmaceuticals has reported additional positive safety and tolerability results for its pipeline candidate TNX-201 from a second Phase III study evaluating the candidate in fibromyalgia.

Topline results of the Phase III RESILIENT study (NCT05273749) were released in December 2023 and showed the trial met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in patients with fibromyalgia.

Additional safety and tolerability data showed the candidate was not associated with increases in systolic or diastolic blood pressure or body weight. In the Changes in Sexual Functioning Questionnaire (CSFQ-14), women who received TNX-102 had a higher CSFQ-14 score relative to those who received placebo consistent with improved sexual function.

Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans to submit a new drug application to the US Food and Drug Administration (FDA) in H2 2024 for TNX-102 SL for the management of fibromyalgia.

The RESILIENT study is a double-blind, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 in fibromyalgia. The two-arm trial enrolled 457 participants in the US across 33 sites.

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RELIEF, the first Phase III trial (NCT04172831) of TNX-102 in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo and showed activity in key secondary endpoints.

In September 2023, Tonix announced that a Phase II trial on TNX-102 in fibromyalgia-type long Covid failed to meet the pre-specified primary endpoint of improving long Covid pain intensity scores at week 14.

Fibromyalgia landscape

According to GlobalData’s Pharmaceutical Intelligence Centre, there are 26 candidates in active development for fibromyalgia. Just two of those, TNX-102 and esreboxetine, are at Phase III development.

GlobalData is the parent company of the Clinical Trials Arena.

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signalling within the central nervous system. It effects an estimated 6 million to 12 million adults in the US, mostly women.

Current standard of care (SOC) includes exercise, behavioural therapies, pain relief and antidepressants.