The company reported the voluntarily withdrawn of BLA for leronlimab as a combination therapy due to CRO data management issues in patients with HIV with resistance to HAART in HIV-MDR
The withdrawal was based on multiple factors, incl. systemic issues with the quality of data collection & monitoring of pivotal clinical trials by the CRO to manage the trials which raised serious concerns about obtaining FDA BLA approval
The company will publish the results of the P-IIb/III trial for the HIV-MDR population shortly in a peer-reviewed journal. The company also submitted its responses to the US FDA for the clinical hold removal & continues to study leronlimab in other HIV-related, NASH & oncology indications
Ref: Globenewswire | Image: CytoDyn
