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Spyre Therapeutics, Inc. (NASDAQ: AGLE) is a biotechnology company dedicated to advancing a robust pipeline of antibody therapeutics aimed at transforming the treatment of inflammatory bowel disease (IBD). The company was formed following the acquisition by Aeglea BioTherapeutics in June 2023, shifting the focus from rare metabolic diseases to innovative IBD treatments. Spyre combines advanced antibody engineering, rational therapeutic combinations, and precision immunology to maximize the efficacy, safety, and convenience of its treatments.
With a promising portfolio, Spyre's lead programs—SPY001 and SPY002—focus on targeting α4β7 and TL1A, respectively.
- SPY001: This program involves a highly potent and selective anti-α4β7 monoclonal antibody, engineered with half-life extension technology for high-concentration, convenient dosing. It is expected to enter first-in-human studies in the first half of 2024, with interim data anticipated by the end of 2024.
- SPY002: A highly potent anti-TL1A monoclonal antibody engineered for half-life extension, targeting both TL1A monomers and trimers with exceptional binding affinity. First-in-human studies are expected to commence in the second half of 2024, with interim data anticipated in the first half of 2025.
Additionally, Spyre is developing SPY003, a monoclonal antibody targeting the p19 subunit of IL-23, expected to enter clinical trials in 2025.
The company operates with robust financial health, having successfully raised $210 million through a private placement in June 2023, and is positioned to fund its operations into 2026. Spyre aims to address the significant and growing IBD market, which includes conditions like Crohn's disease and ulcerative colitis, affecting approximately 1.7 million patients in the United States alone.
Aeglea BioTherapeutics (NASDAQ: AGLE) has announced interim results from its Phase 1/2 clinical trial of pegtarviliase, aimed at treating Classical Homocystinuria. The trial included 13 participants, of which 11 were evaluable. Cohorts 1 and 2 demonstrated a dose-dependent reduction in total homocysteine levels, with reductions of -26.3% and -33.0% respectively. However, results from Cohort 3 (1.35 mg/kg) were inconsistent, showing only a -11.3% reduction. Additionally, the emergence of anti-drug antibodies may have affected results, prompting further exploration of dosing. The company is also seeking strategic alternatives to maximize shareholder value, reducing its workforce and engaging financial advisors for potential transactions.
Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) announced the granting of non-qualified equity awards to four new employees on March 17, 2023. These awards were part of their 2018 Equity Inducement Plan and serve as material inducements for the new hires. In total, options to purchase 63,000 shares of common stock at an exercise price of $0.31 per share were granted, which is equal to the stock's closing price on the grant date. The options will vest over a four-year period, contingent on continued employment. Aeglea focuses on human enzyme therapeutics for rare metabolic diseases and is progressing with its clinical trials for pegtarviliase and pegzilarginase.
Aeglea BioTherapeutics reported its financial results for Q4 and full year 2022, showing a net loss of $18.8 million for Q4, down from $20.4 million in Q4 2021. The full-year net loss increased to $83.8 million compared to $65.8 million in 2021. As of December 31, 2022, the company had $57.3 million in cash and equivalents, expected to fund operations into Q4 2023. Highlights include the appointment of Jeffrey Goldberg as president and CEO and advancements in clinical trials for pegtarviliase and pegzilarginase, with EMA review for pegzilarginase expected in late 2023.
Aeglea BioTherapeutics announced a restructuring to enhance operational efficiency, following a previous overhaul initiated in August 2022. The workforce will be reduced by approximately 15%, and preclinical work on Cystinuria and other programs will be halted for strategic evaluation. Cortney Caudill has been promoted to chief product officer to lead clinical advancements for pegtarviliase, which is currently in a Phase 1/2 trial for Classical Homocystinuria. The company aims to achieve short-term goals while maximizing long-term value for its pipeline products.
Aeglea BioTherapeutics (NASDAQ: AGLE) has granted 1,884,838 non-qualified stock options to newly appointed CEO Jeffrey M. Goldberg, as per Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $1.22 per share, aligned with the stock's closing price on November 29, 2022. Vesting schedule includes 25% after one year, followed by a 36-month ratable vesting contingent on continued employment. Aeglea is focused on innovative human enzyme therapeutics for rare metabolic diseases, with clinical trials underway for pegzilarginase and pegtarviliase.
Aeglea BioTherapeutics (NASDAQ:AGLE) appointed Jeffrey M. Goldberg as CEO and board member effective November 29, 2022. Goldberg brings over 25 years of biotech experience, previously leading Immunitas Therapeutics. His leadership is expected to enhance Aeglea's mission to develop therapies for rare metabolic diseases. However, amidst this transition, the company has decided not to announce interim clinical data from the ongoing Phase 1/2 trial of pegtarviliase in Classical Homocystinuria, which may concern investors.
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