HLB Therapeutics said Friday that the U.S. Food and Drug Administration has approved the execution of an expanded access program (EAP) for its NHPN-1010, a treatment candidate for hearing loss and tinnitus.

HLB Therapeutics has received approval from the U.S. FDA to execute an expanded access program for NHPN-1010, a drug candidate for treating hearing loss and tinnitus,
HLB Therapeutics has received approval from the U.S. FDA to execute an expanded access program for NHPN-1010, a drug candidate for treating hearing loss and tinnitus,

Upon winning the approval, the company began to administer the drug to a chronic tinnitus patient.

NHPN-1010, developed by Oblato, a U.S. subsidiary of HLB Therapeutics, is a candidate for the combined use of OKN-007 under development as a therapy for brain tumors and antioxidant ANN-acetylcysteine. The company has confirmed the therapeutic effect on hearing loss prevention and tinnitus in a preclinical trial.

According to HLB Therapeutics, the company applied for the EAP after Dr. Santosh Kesari of the Saint John's Cancer Institute in the U.S., who had conducted clinical trials to treat recurrent glioblastoma of HLB Therapeutics, suggested its possible efficacy in tinnitus.

Oblato, which retains the right to develop and market NHPN-1010 exclusively, administered NHPN-1010 to a patient who had received treatment for an acoustic nerve tumor by Dr. Kesari.

"Although FDA's approval for compassionate use is different from formal clinical trials, the company expects that the EAP is very valuable for confirming the treatment effect of tinnitus," a company official said. "We also expect that it will produce very precious data in the development and approval process of OKN-007, a glioblastoma treatment substance under development by Oblato."

EAP authorizes the use of new drugs under development for long-term, life-threatening or severe patients that have no other suitable treatment options. The FDA approves it on a limited basis for humanitarian reasons.

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