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3/18/2024
Good afternoon and thank you to everyone for taking the time to join us today. With me on today's call from Alpine are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer, Dr. Stanford Peng, President and Head of R&D, Paul Rickey, Chief Financial Officer, and Dr. Remy Durand, Chief Business Officer. Before I turn the call over to Mitch, I'd like to remind you that we'll be making forward-looking statements during today's call. These forward-looking statements represent our views as of today and are based on our current expectations and consequently involve risk and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of such risks and uncertainties. I encourage you to refer to the most recent SEC filings regarding the risk factors associated with these statements. Mitch, please go ahead.
Thank you, Tamrae, and thank you to all those who are participating in the webcast today. 2023 was a transformational year for Alpine. with initial IgA nephroscopy data presented at the American Society of Nephrology's Kidney Week, suggesting a best-in-class profile for Povatectin sets, our wholly-owned, next-generation, dual-VAC April inhibitor, with once-monthly dosing developed using our direct evolution platform. We are still only in the early stages of exploring the full potential of Povatectin sets. On the back of strong enthusiasm around ASN, we close an oversubscribed $150 million equity offering to accelerate multiple development activities. With our encouraging data set in IGAN, convenient once-monthly dosing regimen, and strong balance sheet, we are rapidly advancing development of POVI as a potentially meaningful new therapeutic option for patients living with IGAN, lupus, and multiple other autoimmune and inflammatory diseases. Looking ahead, we are well positioned for meaningful catalysts in 2024 and beyond. We plan to present additional data on pogutaxiceptin IgA nephropathy, including follow-up data from the 80 mg monthly and initial data from the IgAN 240 mg monthly dose cohorts at the Rural Congress Interfology meeting next month. Following these data, in the second half of the year, we plan to initiate Rainier, pivotal Phase III study of pogutaxiceptin IgA nephropathy, and Denali, a Phase II study of pogutaxiceptin SLE. In addition to updates in our clinical studies, we look forward to sharing translational data that further supports the best and best potential of Cova-Tachyceps in multiple diseases. I now hand the call over to Stanford to review our progress and provide updates on our development plan for Cova-Tachyceps in more detail. Stanford. Thank you, Mitch.
As Mitch has described, the emerging clinical findings with Cova-Tachyceps continue to inspire us to advance as rapidly as possible. At last year's kidney week meeting, we reported the first clinical observations with pulpitacicept and IGAN, where it was associated with a greater than 50% reduction from baseline and proteinuria at six months, as measured by urinary protein and creatinine ratio, or UPCR. In addition, the majority of patients met remission criteria as defined as reduction in UPCR to less than 0.5 grams per gram, at least a 50% reduction in UPCR from baseline, and stable renal function as assessed by estimated glomerular filtration rate, or EGFR. Importantly, these findings were associated with significant reduction in the key IgM biomarker, GGIGA1, supporting the concept of POVATAC-CEP as a disease-modifying therapy. As a reminder, the improvable efficacy target has historically been a 30% reduction in protein area at 9 months. While our very encouraging findings continue to hold up with additional patients and with longer follow-up, POVATAC-CEP could indeed be a particularly compelling therapeutic option for patients with IgM and other autoimmune diseases. Therefore, since ASN, we've been making every effort to prepare the program and the company for the next pivotal phase of development. We look forward to the opportunity to provide a formal clinical data update of Cova-Tac Accept and IGAN next month at the World Congress of Nephrology, which will take place in a late-raising poster. In the meantime, our primary development goal for Cova-Tac Accept is its advancement this year to a pivotal trial in IGAN, which we're calling Rehear. Of course, several other autoimmune and or inflammatory disease indications remain of great potential interest for Cova-Tachycept. First, lupus remains a key indication, second only to IgAIN, supported by the clinical validation of the pathway in the disease by BAC inhibition and wild-type Tachy-Ig molecules. We continue to plan to initiate a Phase II study in lupus, called the NAWI, later this year. Second, we continue to explore other renal indications in the Ruby 3 study, At last year's kidney week, we described a single patient with primary membranous nephropathy, or PMN, who had achieved an immunological remission on comatose. Such a finding suggests that other autoantibody-related diseases may benefit from comatose. Indeed, we continue to enroll additional subjects with PMN. As a reminder, Ruby 3 is also enrolling lupus nephritis and has just recently opened an ANCA-associated vasculitis cohort. In addition, we continue to explore autoimmune cytopenias in the Ruby 4 study. We look forward to future opportunities to share these collected data. Finally, ongoing and emerging preclinical and translational data continues to suggest additional therapeutic areas like neurology or allergies for COVID-19 test. Last year at Kidney Week, we observed a significant reduction in IgE in IgAN patients who have received COVID-19 test, suggesting potential applicability in IgE-related diseases like allergies. We also presented data on Cova-Tachycept in a mouse model of Myasthenia gravis at the American Association of Neuromuscular and Electrodiagnostic Medicine annual meeting. And next month, we will present data on Cova-Tachycept in a mouse model of autoimmune encephalitis at the American Academy of Neurology meetings. In the Myasthenia model, Cova-Tachycept appeared superior to clinically relevant comparators such as FCR inhibition or B-cell depletion. Weaknesses may in part be related to some unique biophysical and or other developmental characteristics of Clobatacacept, which confer greater tissue penetration and or distribution than wild-type tachy-IT. Data supporting this latter statement will be part of a poster later this week at the European Group's meeting. Altogether, these developments only reinforce the potential for Clobatacacept As a reminder, Phobatacacept was discovered in-house by our proprietary directed evolution protein engineering platform, which has been quite productive and continues to generate novel drug candidates that may be of great future interest. We therefore look forward to opportunities to provide further updates, not only on Phobatacacept, but also on our development pipeline in the near future. I'm now trying to call over to Paul Rickey, our Chief Financial Officer.
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