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On March 15, 2023, Homology Medicines, Inc. (FIXX) announced two presentations during the ACMG Annual Clinical Genetics Meeting, showcasing preclinical data supporting the Phase 1 trials for phenylketonuria (PKU) and Hunter syndrome (MPS II). The data highlighted the efficacy of HMI-103, showing it was ten times more potent at reducing blood Phe levels compared to HMI-102. The company is on track to release initial clinical data for both trials in mid to late 2023. The studies also feature an immunosuppression regimen aimed at enhancing vector administration efficacy.
Homology Medicines, Inc. (Nasdaq: FIXX) provided a comprehensive update on clinical trials and financial results for 2022. The company marked a milestone by dosing the first participant in the Phase 1 pheEDIT trial for phenylketonuria (PKU), with initial data expected mid-2023. Anticipated data from the HMI-203 trial for Hunter syndrome is set for the second half of 2023. Financially, the net loss for Q4 2022 was $34.3 million, a slight increase from $33.6 million in Q4 2021, but a significant decrease for the year, dropping from $95.8 million in 2021 to $5.0 million in 2022. Homology expects its cash runway to last until Q4 2024.
Homology Medicines, Inc. (Nasdaq: FIXX) has promoted Dr. Julie Jordan to Chief Medical Officer, following her success as Senior Vice President, Head of Clinical Development and Operations. Dr. Jordan has been pivotal in advancing the company’s gene editing and therapy programs, specifically the pheEDIT trial for phenylketonuria (PKU) and the juMPStart trial for Hunter syndrome. Initial clinical data for both trials is expected in mid-2023 and the second half of 2023, respectively. Dr. Jordan's extensive experience and strong community relationships are anticipated to further enhance the company's clinical initiatives in rare diseases.
Homology Medicines (Nasdaq: FIXX) announced that CEO Albert Seymour, Ph.D., will speak at the 43rd Annual Cowen Healthcare Conference on March 8, 2023, at 10:30 a.m. ET. The event will focus on gene editing and will be streamed live on the company’s website.
Homology is a clinical-stage genetic medicines company dedicated to treating rare diseases through innovative therapies. Its key programs include HMI-103 for phenylketonuria (PKU), HMI-203 for Hunter syndrome, and HMI-102 for adults with PKU. The company is known for its proprietary AAVHSCs vectors that enhance gene delivery.
Homology Medicines recently announced promising preclinical data on its gene therapy candidates, particularly HMI-204 for metachromatic leukodystrophy (MLD) and ongoing trials for phenylketonuria (PKU). The data supports a targeted immunosuppression approach, which effectively reduced immune response to AAVHSC administration while enhancing gene expression. Presentations at the 19th Annual WORLD Symposium detailed significant findings, including a notable increase in PAH gene expression and improved CNS distribution with HMI-204, indicating robust enzyme activity levels that could lead to efficacy. Initial clinical data from ongoing trials is expected mid-year and later in the year.
Homology Medicines (FIXX) has announced updates on clinical trials for its gene editing and gene therapy candidates, HMI-103 and HMI-203. The first participant in the pheEDIT Phase 1 trial for phenylketonuria (PKU) has been dosed, with initial data expected mid-2023. Meanwhile, the juMPStart trial for Hunter syndrome is also progressing. New preclinical data confirm the efficacy of an immunosuppression regimen in trials, enhancing the potential of HMI-103, which has shown significant potency in preclinical models. The company maintains a strong cash position to support operations into Q4 2024.
Homology Medicines (FIXX) reported its Q3 2022 financial results, highlighting a cash position of $201.1 million, providing runway into Q4 2024. The company is advancing its clinical programs, including pheEDIT and juMPStart, aiming for updates by year-end. CEO Albert Seymour reiterated the prioritization of resources toward ongoing trials, pausing the pheNIX trial. The net loss for the quarter was $(33.7) million, with total operating expenses rising to $33.7 million. Collaboration revenues fell to $0.8 million, down from $1.7 million a year ago.
Homology Medicines (FIXX) announced a presentation on the Phase 1 dose-escalation study of its gene editing candidate HMI-103 for treating phenylketonuria (PKU). Presented at the ASHG Annual Meeting, data highlighted preclinical efficacy in PKU models and the role of modified base sequencing in optimizing AAV vectors. The trial aims to enroll three cohorts with up to three patients each and includes a steroid-sparing regimen. The research supports the potential of HMI-103 to normalize Phe levels, showcasing advancements in gene editing.
Homology Medicines, Inc. (Nasdaq: FIXX) announced its participation in key conferences, highlighting its commitment to advancing genetic medicine. On October 11, CEO Albert Seymour will present at the Cell & Gene Meeting on the Mesa and participate in a panel discussion. Chairman Arthur Tzianabos will also speak on new business models for manufacturing investments. Additionally, at the American Society of Human Genetics Annual Meeting on October 26, the company will present research on gene editing and a clinical study for phenylketonuria (PKU).
Homology Medicines announces the promotion of Albert Seymour, Ph.D., to CEO, succeeding Arthur Tzianabos, Ph.D., who becomes Chairperson of the Board. Both joined the company in 2016, collaborating to advance its gene therapy and gene editing programs. Dr. Seymour aims to drive value for shareholders while providing updates on key clinical candidates by year-end. The company emphasizes its strong financial position and pipeline progress, with ongoing work on therapies for rare diseases such as PKU and Hunter syndrome.
