SAN FRANCISCO and WALTHAM, Mass. - Apogee (NASDAQ:APOG) Therapeutics, Inc. (NASDAQ: APGE), a biotechnology firm focused on inflammatory diseases, today announced positive interim results from a Phase 1 study of APG777, a treatment candidate for moderate-to-severe atopic dermatitis (AD). The study revealed that APG777, an anti-IL-13 antibody, could potentially be administered every three or six months, a significant extension over current biologic therapies that require dosing every two to four weeks.
The pharmacokinetic (PK) data indicated a half-life of approximately 75 days, suggesting the potential for improved clinical responses with higher drug exposures during induction phases and less frequent dosing for maintenance. The pharmacodynamic (PD) data showed sustained inhibition of AD biomarkers pSTAT6 and TARC for about three months, with the effects ongoing at the time of the data cut.
APG777 was well tolerated in doses up to 1,200mg, aligning with the safety profile of the anti-IL-13 class. The most common treatment-emergent adverse events were related to the injection site, headaches, and bruising, with no severe adverse events leading to study discontinuation reported.
Based on these findings, Apogee plans to initiate a randomized, placebo-controlled Phase 2 clinical trial in the first half of 2024. The trial aims to test greater pathway inhibition during induction to potentially deliver better clinical outcomes for AD patients.
The company's CEO, Michael Henderson, M.D., expressed enthusiasm for the next development phase of APG777, highlighting the potential for a transformational therapy that could extend dosing intervals and improve patient responses compared to the current standard of care.
The forthcoming Phase 2 trial will enroll approximately 110 patients with a primary endpoint of mean percentage changes in the Eczema Area and Severity Index (EASI) score from baseline to Week 16. A maintenance phase will follow for patients benefiting from treatment, evaluating 3- to 6-month dosing intervals.
The development of APG777 is part of Apogee's strategy to provide differentiated biologics for diseases such as AD, chronic obstructive pulmonary disease, asthma, and others. The company believes its advanced antibody engineering can optimize half-life and other properties to improve patient care.
Apogee's announcement is based on a press release statement.
InvestingPro Insights
As Apogee Therapeutics, Inc. (NASDAQ: APGE) advances its clinical trials for APG777, investors are closely monitoring the company's financial health and market performance. With a market capitalization of $2.12 billion, the biotech firm is navigating a challenging landscape. According to InvestingPro data, the company's adjusted Price-to-Earnings (P/E) ratio stands at a negative 30.27 based on the last twelve months as of Q3 2023, reflecting investor skepticism about future profitability. Moreover, Apogee's operating income during the same period was negative $72.74 million, indicating operational challenges.
However, the stock has seen a significant return over the last week, with a 19.94% increase in price total return. This is part of a larger trend, as the stock has also returned 96.61% over the past year. Additionally, the stock is trading near its 52-week high, at 96.51% of the peak price. This momentum could be a reflection of investor confidence in the potential of APG777 and the company's pipeline.
InvestingPro Tips for Apogee Therapeutics highlight two key insights: the company holds more cash than debt on its balance sheet, providing a level of financial stability, and the stock is currently in overbought territory according to the Relative Strength Index (RSI), which could signal a pullback in the near term. For investors seeking more in-depth analysis, there are additional tips available on InvestingPro, including insights on gross profit margins, net income projections, and profitability expectations. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and unlock a wealth of financial data and expert analysis on companies like Apogee Therapeutics.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.