SAN FRANCISCO and WALTHAM, Mass. - Apogee (NASDAQ:APOG) Therapeutics, Inc. (Nasdaq: APGE), a biotechnology firm focused on inflammatory and immunology therapies, announced encouraging results from its ongoing Phase 1 clinical trial of APG777, a treatment for moderate-to-severe atopic dermatitis (AD). The data, presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting, showed a favorable safety profile and sustained biomarker inhibition for up to nine months.
The trial involved 40 healthy volunteers across single and multiple dose cohorts. APG777 demonstrated a half-life of approximately 75 days, significantly longer than current AD treatments, and consistent pharmacokinetic properties, with dose-proportional increases in maximum concentration and area under the curve. Pharmacodynamic results indicated near-complete inhibition of pSTAT6 and sustained suppression of TARC, key biomarkers associated with AD, for up to nine months. No serious adverse events or dose-dependent trends were observed.
These findings bolster the ongoing Phase 2 trial of APG777 for patients with moderate-to-severe AD, suggesting the potential for less frequent dosing intervals of three to six months, compared to the two-to-four week regimen of existing therapies. Topline data from part A of the Phase 2 trial is expected in the second half of 2025.
APG777, an extended half-life monoclonal antibody targeting IL-13, a primary driver of AD, has shown equivalent or superior potency in preclinical studies compared to lebrikizumab. The drug's pharmacokinetic profile may offer improved clinical responses and a reduced dosing frequency, addressing challenges such as patient compliance associated with current treatments.
Apogee's Chief Medical Officer, Dr. Carl Dambkowski, expressed confidence in the potential of APG777 to achieve maintenance dosing every three to six months for AD patients. The company anticipates sharing further updates on its programs and R&D strategies on December 2nd.
Apogee Therapeutics is advancing a range of novel biologics for large inflammatory and immunology markets, including AD, asthma, and chronic obstructive pulmonary disease. APG777 is the first clinical-stage candidate from their collaboration with Paragon Therapeutics, Inc.
This news is based on a press release statement from Apogee Therapeutics and does not constitute an endorsement of the company's claims. Investors and interested parties are advised that forward-looking statements involve risks and uncertainties, which may cause actual results to differ materially from those projected.
In other recent news, Apogee Therapeutics has shown considerable progress in its clinical trials and product development. The company has received FDA approval for Dupixent, an add-on treatment for Chronic Obstructive Pulmonary Disease, marking a significant milestone. Guggenheim has maintained its Buy rating on Apogee, highlighting the company's potential to tap into the Th2 disease market, projected to exceed $50 billion by 2030. BTIG has also reaffirmed its Buy rating, citing positive results from APG777's Phase 1 trials.
Apogee has initiated a Phase 1 trial for APG990, a promising drug for atopic dermatitis, with interim data expected in 2025. Concurrently, the company is advancing a Phase 2 trial for APG777, another novel antibody targeting atopic dermatitis and asthma. Jeff S. Hartness has recently been appointed as the new Chief Commercial Officer at Apogee, and Dr. Lisa Bollinger has joined the company's board of directors, bringing valuable regulatory expertise.
The company's financial position remains robust, with $790 million in assets expected to support the continued development of its pipeline into 2028. Analysts from BTIG and Stifel have maintained their Buy ratings on Apogee's stock, reflecting confidence in the company's drug pipeline. These are the recent developments at Apogee Therapeutics.
InvestingPro Insights
Apogee Therapeutics' promising clinical trial results for APG777 are reflected in the company's strong market performance. According to InvestingPro data, Apogee has seen an impressive 217.08% price total return over the past year, indicating significant investor confidence in the company's potential.
Despite the positive clinical developments, it's important to note that Apogee is not yet profitable. An InvestingPro Tip reveals that analysts do not anticipate the company will be profitable this year. This is not uncommon for biotechnology firms in the early stages of drug development, as they often prioritize research and clinical trials over immediate profitability.
Another relevant InvestingPro Tip highlights that Apogee holds more cash than debt on its balance sheet. This strong liquidity position is crucial for a company conducting expensive clinical trials and could provide the financial runway needed to bring APG777 through its ongoing Phase 2 trial and potentially to market.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips that could provide valuable insights into Apogee's financial health and market position.
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