SAN DIEGO, CALIFORNIA — Ting Therapeutics has announced that its investigational drug TT004 has received approval to begin clinical testing in China, clearing the way for a Phase Ib study evaluating its potential to protect patients from the harmful effects of cisplatin chemotherapy, including treatment-related hearing loss.
The study, which will be conducted at Fudan ENT Hospital in Shanghai, will evaluate the safety and tolerability of oral TT004 administered alongside standard cisplatin chemotherapy in patients with head and neck cancer. The trial has received institutional ethics approval and is preparing to begin patient recruitment.
The authorization from China’s Center for Drug Evaluation (CDE) marks the first planned human evaluation of TT004, which has demonstrated protective effects against hearing loss and kidney injury in preclinical research.
Addressing Cisplatin-Induced Hearing Loss
Cisplatin is a widely used chemotherapy drug for several cancers, but its effectiveness can be accompanied by significant adverse effects, including permanent sensorineural hearing loss, kidney injury, and other treatment-related complications.
According to Ting Therapeutics, cisplatin-associated hearing loss can affect up to 80% of patients, while acute kidney injury occurs in approximately 30%. The company also cites treatment-related toxicities as a factor in chemotherapy discontinuation or modification among approximately 40% of patients.
TT004 is being developed as a chemoprotective therapy intended to reduce damage to healthy tissues without interfering with cisplatin’s anticancer activity.
In preclinical studies described by the company, TT004 increased survival following cisplatin exposure threefold and reduced cisplatin-induced hearing loss and kidney injury by approximately 70%. Ting Therapeutics reported that these protective effects were achieved without compromising cisplatin’s anticancer effects in the experimental models studied.
However, these findings have not yet been demonstrated in humans, and it remains unknown whether the treatment can provide similar protection in patients receiving chemotherapy.
“These findings support our vision of TT004 as a chemoprotective therapy that could improve the tolerability of cisplatin while maintaining its anticancer efficacy. Our goal is to reduce the suffering caused by treatment-related toxicities and help more patients receive and complete effective chemotherapy.”
–Jian Zuo, PhD, Co-Founder and CEO of Ting Therapeutics
Phase Ib Trial Planned in Shanghai
Ting Therapeutics recently licensed the Chinese development rights for TT004 to Rising Dragon, a biotechnology company based in China. The companies collaborated on the development of an oral tablet formulation and obtained investigational new drug (IND) authorization from China’s CDE to begin clinical evaluation.
The upcoming Phase Ib study will be conducted in collaboration with oncologists and otolaryngologists at Fudan ENT Hospital in Shanghai. It will assess the safety and tolerability of TT004 when administered alongside standard-of-care cisplatin chemotherapy in patients with head and neck cancer.
Although the preclinical findings suggest potential benefits for protecting hearing and kidney function, the initial clinical study is designed to evaluate whether TT004 can be administered safely to patients receiving cancer treatment.
The company has not yet reported human efficacy results for TT004, and the treatment remains investigational.
Potential Implications for Hearing Preservation
Cisplatin-induced ototoxicity remains an important concern in oncology and hearing healthcare because treatment-related hearing damage can be permanent and may affect communication, quality of life, and long-term rehabilitation needs.
Developing treatments that protect the inner ear without reducing the effectiveness of chemotherapy represents an important area of investigation, particularly for patients receiving cisplatin-based treatment regimens.
TT004’s transition into clinical development represents an early step toward determining whether the protective effects observed in laboratory and animal models can translate into meaningful benefits for patients.
If initial safety findings are favorable, additional clinical research would be needed to establish whether TT004 can prevent or reduce hearing loss and other complications in people receiving cisplatin.
About Ting Therapeutics
Founded in 2018 and based in San Diego, California, Ting Therapeutics develops investigational therapies aimed at preventing and treating hearing loss and other forms of treatment-related tissue injury. The company’s research pipeline includes approaches targeting hearing loss associated with chemotherapy, noise exposure, antibiotics, aging, and other causes.
Source: Ting Therapeutics
