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| Statement |
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| This and other favorable quantitative sensory testing profiles makes me think that this is a true clinical signal |
| In our animal studies, we see good penetration of the compound into the brain |
| We're pleased to report a quarter of significant milestones achieved |
| Again, this is accompanied by what initially looked like a favorable safety and tolerability profile |
| It's important that TRV045's actions in both the pain cart study and the EEG study are occurring in what appears to be a favorable safety and tolerability profile, including, again, with respect to cognition and sedating side effects |
| Its effects demonstrate what I believe to be strong evidence that 045 is exerting an effect on central pain processing with a favorable safety and tolerability profile |
| In addition, last month, we also announced favorable top-line safety and tolerability data from these studies |
| We believe the data generated to-date supports the therapeutic potential of TRV045 as a non-opioid with a novel mechanism of action, expected once daily dosing, and a favorable safety tolerability profile |
| In short, we are very pleased with the outcome of our proof-of -concept study program |
| These data are important since this validated model provides strong support for the potential efficacy of 045 in the treatment of chronic neuropathic pain in patients |
| Finally, in our clinical studies, TRV045 has shown no evidence of lymphopenia, a known on-target effect of existing S1P modulating drugs, and has shown a favorable safety and tolerability profile with respect to cardiac and pulmonary function and an ophthalmologic examination |
| We're efficiently deploying resources and pursuing our contracting strategy, and we'll continue to assess performance and the best path forward for OLINVYK |
| That gives us a better opportunity as we proceed into Phase 2 to do full dose ranging work that we'd like to do |
| During the quarter, we released very promising top-line results from two Phase 1 proof-of-concept studies where we demonstrated a statistically significant dose dependent effect in a validated model of neuropathic pain and statistically significant EEG changes and evidence of early reduction in cortical excitability in the TMS study, a biomarker for epilepsy |
| As I mentioned previously, we've been pleased with the outcome of these studies |
| I believe the parallel evidence of potential benefit in both pain and epilepsy models indicate that the drug is somehow modulating central hyper-excitability of the brain, which supports its therapeutic potential |
| But it's certainly terrific right now to have these choices in front of us |
| Taken together, we believe these features position 045 as a compound especially well-suited to explore its potential use in the treatment of chronic neuropathic [Technical Difficulty] action on the brain and to assess pharmacodynamic outcomes relevant to our interest in chronic neuropathic pain and epilepsy |
| If it continues to demonstrate this favorable safety profile, it would still have the potential to be an important addition to the current options |
| In short, given this early phase of development, this compound looks as promising as any centrally acting analgesic that I've seen |
| So we know that there's strong CNS components even in conditions like low back pain and osteoarthritis that often start out as being more nociceptive pain |
| We continue to investigate partnering and other opportunities for OLINVYK, TRV045, and our other pipeline candidates, which would provide additional resources and build shareholder value |
| Clauw is an internationally recognized expert in the clinical pathophysiology of chronic pain |
| We're well within our targeted efficacy range |
| We also expect a readout shortly from the NIH's Epilepsy Therapy Screening Program on our seizure prevention model, which will provide additional insight into 045's potential to exert a disease-modifying effect in epilepsy, and we believe could make TRV045 unique among anti-epileptic drugs |
| Clauw, only in that I think what's helpful is that we have an opportunity in both neuropathic pain, and Dr |
| There are also significant orphan disease opportunities since this type of pain plays a major role in conditions such as sickle cell disease and hypermobility syndrome such as Ehlers-Danlos syndrome |
| Both studies highlighted TRV045's unique mechanism of action and CNS target engagement |
| It's clear that more treatment options are needed, especially non-opioid options that have normal mechanisms and offer potential improvements in any of these areas |
| Let's start with TRV045, our novel S1P receptor modulator that we're studying for potential use in chronic pain and epilepsy two large market opportunities |
| Statement |
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| OLINVYK commercial business remains challenging |
| And then you have all these other conditions like fibromyalgia that are now actually being called primary pain conditions because that, the pain is the primary problem |
| In the third quarter, our net loss was $7.9 million, or $0.57 cents per share, compared to $15.3 million, or $2.24 per share for the same period last year |
| Even fewer patients continue to use drugs long-term, because of all the side effects, especially issues with cognition and sedating side effects |
| As with all opioids, serious life-threatening or fatal respiratory depression may occur in patients treated with OLINVYK, as indicated in the box warning |
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