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| Statement |
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| What we're excited about from a KIT inhibitor perspective, is the data that was generated through an antibody program in Phase 2 where they have seen some of the best efficacy in this disease so far |
| And given the potency, given the PK, given the huge multiples we drive over the protein-adjusted EC90, we're very hopeful that it should show, efficacy, comparable to zelicapavir |
| Make sure we've got strong commercial rationale in terms of competitive landscape, potential product profiles, we set all that stuff |
| So it's a good opportunity |
| We've observed favorable in vitro and in vivo ADME properties in our prototype, including a low potential for off-target tissue penetration, a long half-life, and low drug-drug interaction potential |
| But we're very encouraged by our position in the field, sort of the leadership position we have in RSV portfolio, and also the fact that there are no approved drugs on the market to each unmet need |
| It was really gratifying to see that |
| We are very excited about our pipeline growth in immunology and are pursuing additional targets, with plans to introduce a second immunology program this year |
| We believe that we are well-positioned to pursue immunologic indications, and are excited to advance our new program, in chronic spontaneous urticaria, or CSU, which is a severely debilitating chronic inflammatory skin disease |
| Overall, the antibody has had a good safety profile |
| We believe both zelicapavir and EDP-323 have robust potential as monotherapies, but we're also excited by the opportunity, to combine them and potentially broaden the treatment window for addressable patient populations |
| We have been pleased to see a more normal RSV season in North America |
| Obviously, having a good market opportunity, something that has a high unmet medical need, ideally programs where there's a clear clinical path and biomarkers, or early signs of efficacy that we can get early on in the program and really understanding the underlying disease, cause of the disease and having confidence in the target and mechanism are some of the criteria we look at |
| So, I think there's a great opportunity to build, the first opportunity for an RSV treatment ever in each of those patient populations and yet other high-risk patient populations |
| And they're doing quite well, in prophylaxis, even though only a small portion of the eligible patient population is getting vaccinated and everybody else, which is the overwhelming majority of people, aren't getting vaccinated, and would still be susceptible to infections |
| We advanced EDP-323 into the challenge study based on positive Phase 1 results in, which the drug demonstrated favorable safety, tolerability, and pharmacokinetics in healthy volunteers, and we are on track to report data from the challenge study in the third quarter of 2024 |
| In the first quarter of 2024, Enanta began an important year, which has the potential to advance our programs, in both virology and immunology and drive value across the company |
| And we'd feel comfortable moving forward in pediatrics with positive results from our pediatrics study |
| And really what we're hoping to see is some directional data and numerical trends in the virology endpoints that give us the confidence to take the program forward into a larger, more robust Phase 3 program as we move forward |
| But again, numerical trends and directional data showing that zelicapavir is showing an improved trend in virology, compared to placebo, would give us the confidence to move forward into a Phase 3 study |
| Through our recent expansion into immunology, our mission continues to center around the development of small molecule treatments for indications of high unmet need, and we are leveraging our drug discovery capabilities, to bolster our pipeline for near and long-term value creation |
| RSVPEDs was designed as a smaller study that, would allow us to demonstrate a trend toward improved virology metrics for zelicapavir and to also move forward expeditiously into registrational studies |
| I'm glad some progress |
| Our team is focusing on areas, where there is a strong understanding of the underlying disease pathology, allowing us to target the root cause of the disease |
| Once we have a good, more, crisp target guidance to provide it, we will |
| But obviously, among the things we're looking at, is just really honing down potency, selectivity, making sure we've got good safety |
| But we did see a nice uptick in this Northern Hemisphere season |
| Fantastic |
| Both have fast-track designation from the FDA |
| Those studies did read out positive |
| Statement |
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| So fairly severe |
| Despite the availability of vaccines and prophylactic monoclonal antibodies, the uptake has been low, and breakthrough infections will still occur |
| And so, we're also not going to underestimate what that adult market could ultimately look like |
| And so, what we did find out is that it didn't get worse with longer dosing, and so it seems quite manageable, at least at the levels that they're observing so far in the clinic |
| You're sounding a little low there |
| Net loss for the three months ended December 31, 2023 was $33.4 million, or a loss of $1.58 per diluted common share, compared to a net loss of $29 million, or a loss of $1.39 per diluted common share for the corresponding period in 2022 |
| So, we still see the market and the clinical opportunity persisting there |
| Patients with CSU also experience symptoms beyond the skin manifestations, including sleep disturbances, fatigue, irritability, anxiety, and depression |
| The disease can be severely disabling, significantly impair quality of life, and affect performance at work or school |
| If that helps |
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