FIXX Stock
FIXX Stock

Homology Medicines, Inc. (FIXX) stock plummeted 19.69% in the pre-market trading session at the price of $3.10 after it published data regarding the Phenix Gene Therapy Trial for adults with phenylketonuria. Homology Medicines is a genetic pharmaceuticals firm devoted to improving the lives of patients with rare conditions by addressing the primary cause of the disease.  

FIXX Published HMI-102 Trial Data  

On 18th February 2022, FIXX reported that its pheNIX gene therapy trial in adults with PKU had been placed on clinical hold by the Food and Drug Administration. The company had informed that its study needs some changes in risk mitigation measures in compliance with observations from liver function tests. Homology anticipates receiving a clinical hold letter within the month.

The company is recently working on its pheEDIT trial of HMI-103 for phenylketonuria. It expects to provide program updates for the juMPStart trial of HMI-203 by the end of the year. 

Management Comments 

Chief Executive Officer of FIXX, Arthur Tzianabos, commented that they were looking ahead to working with the Federal Investigation Agency to address its queries once they get the official letter. This hold on their phenylketonuria gene therapy trial had based on clinical observations in the pheNIX trial study. It, however, is not associated with the company’s other clinical programs or CMC/manufacturing capacities. Homology will move towards the next stages after receiving further details from FDA, Arthur added.   

FIXX Presented at WORLDSymposium Annual Meeting 

Earlier on 10th February 2022, FIXX delivered multiple presentations on HMI-203 gene therapy to treat Hunter syndrome. The study, evaluated in juMPStart, is an open-label, dose-escalation, phase-I clinical trial for adults suffering from Hunter syndrome.  

In oral presentations, planned endpoints and the key eligibility criteria for the juMPStart trial had discussed. Homology had also published data regarding the HMI-203 studies. Additionally, the company provided feedback from the patients and key opinion leaders on the unmet medical need in Hunter syndrome. These presentations at the WORLDSymposium Annual Meeting also included information on the AAVHSC platform and its potential to treat lysosomal storage conditions.

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