Alpine Immune Sciences to Present Povetacicept (ALPN-303) Phase 1 (RUBY-1) Study Data at the 2023 American Academy of Dermatology Annual Meeting

Rhea-AI Summary

On March 18, 2023, Alpine Immune Sciences (NASDAQ: ALPN) will present clinical data from the RUBY-1 Phase 1 study of povetacicept at the American Academy of Dermatology Annual Meeting. The study focuses on the safety, tolerability, pharmacokinetics, and pharmacodynamics of povetacicept, a dual B cell cytokine antagonist targeting autoimmune blistering diseases. Results indicate that povetacicept is well tolerated at doses up to 960 mg, demonstrating dose-dependent pharmacokinetics and significant reductions in immunoglobulins. This paves the way for future clinical advancements.

Positive

• Povetacicept demonstrated good tolerability at doses up to 960 mg.
• The study supports a once every four-week dosing regimen for future trials.
• Povetacicept showed effective reduction in circulating immunoglobulins and antibody-secreting cells.

Negative

• None.

SEATTLE--(BUSINESS WIRE)-- Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present an ePoster with an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, highlighting clinical data from RUBY-1, a phase 1 healthy volunteer (HV) study of povetacicept, a dual B cell cytokine antagonist being developed for multiple B cell and/or autoantibody-related diseases.

Date/Time: March 18, 2023, at 9:30am - 9:35am CST
Poster Title: Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept (ALPN-303), a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Blistering Diseases (RUBY-1)
Poster Number: 42273
Location: Ernest N. Morial Convention Center, Level 1, Hall E, Poster Center 2 in Exhibit Hall
Presenter: Stanford Peng, MD, PhD, President and Head of Research and Development, Alpine Immune Sciences

About Povetacicept (ALPN-303) and the RUBY-1 Phase 1 Study
Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in the activation and survival of B cells, particularly antibody-secreting cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept exhibits greater potency in preclinical studies versus wild-type TACI-based comparators, as well as other inhibitors of BAFF and/or APRIL alone. Povetacicept is in development for multiple B cell and/or autoantibody-related diseases.

RUBY-1 (NCT05034484) is a phase 1, randomized, placebo-controlled study in healthy adult volunteers designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of intravenously and subcutaneously administered povetacicept. Povetacicept was well tolerated at doses up to 960 mg, with dose-dependent pharmacokinetics and reductions in circulating immunoglobulins and antibody-secreting cells, supporting the use of a once every four-week dose regimen for subsequent studies.

About Alpine Immune Sciences
Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; and the timing of our public presentations and potential publication of future clinical data. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and prolonged than currently anticipated; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230316005751/en/

Investors & Media Contact:

Temre Johnson

Alpine Immune Sciences, Inc.

ir@alpineimmunesciences.com

Source: Alpine Immune Sciences, Inc.

FAQ

What did Alpine Immune Sciences present at the AAD Annual Meeting regarding ALPN?

Alpine Immune Sciences presented clinical data from the RUBY-1 Phase 1 study of povetacicept (ALPN-303) focusing on its safety and efficacy.

What are the results of the RUBY-1 Phase 1 study for povetacicept?

The RUBY-1 study indicated that povetacicept is well tolerated, with reductions in circulating immunoglobulins and antibody-secreting cells.

What is the dosing regimen for povetacicept based on the study?

The study supports a once every four-week dosing regimen for povetacicept in future clinical trials.

What is the significance of the RUBY-1 Phase 1 study for investors in ALPN?

The positive results from the RUBY-1 study may enhance investor confidence in ALPN's development pipeline and potential market impact.