Update on new tinnitus drug (GW-201) from NEOMED researcher Jianxin Bao and Gateway Biotechnology

The name of the leading tinnitus drug candidate is tetrandrine (TET) and researchers believe it could prevent and treat tinnitus by targeting both inflammatory and calcium signaling pathways.

BACKGROUND:

Recent media coverage of Bao’s efforts to develop the first human treatment for tinnitus left many people itching to know more about the mysterious new drug.

The articles teased at the possibility of a cure… but did not provide specific details or even hint at how it might work.

The website for Bao’s company, Gateway Biotechnology, appeared to be equally secretive. The only reference to an upcoming tinnitus treatment in their pipeline was a code name: GW-201.

Sadly, a search for GW-201 on Google did not fill in the blanks.

But today, we have finally tracked down those elusive details concerning Bao’s tinnitus research and GW-201 – including a copy of the official project abstract.

The information was found by searching through a U.S. Department of Health & Human Services (HHS) grant-award program database for new entries with “Gateway Biotechnology Inc” as the recipient name.

Tetrandrine (TET) for tinnitus: a leading drug candidate almost ready for human trials?

TARGETING MULTIPLE SIGNALING PATHWAYS FOR TINNITUS PREVENTION AND TREATMENT

Award Number: R44DC018759
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH
AWARD ABSTRACT:
Subjective tinnitus is the perception of a phantom sound, which negatively impacts the quality of life for millions of people worldwide. Despite the great demand for remedy, there are no FDA-approved drugs to prevent or treat tinnitus. Possible causes of tinnitus are complicated. The current view is that hyperactivity in the central auditory nervous system contributes to the majority of tinnitus cases. This abnormal electrical activity, including an increase in delta-band activity, may be the direct result of an increase in T-type calcium channel activity. Other studies suggest that inflammatory responses within the brain may be involved in the development and persistence of tinnitus; therefore, drug candidates targeting both inflammatory and calcium signaling pathways may act synergistically to prevent and treat tinnitus. Tetrandrine (TET), an approved drug used in China, exhibits both anti-inflammatory and calcium channel-blocking properties. Using a new tinnitus detection method in mice, we have shown that both salicylate-induced and noise-induced tinnitus can be effectively treated by TET in a dose-dependent manner. Our hypothesis is that TET or its chemical analogs can be developed as drugs to prevent and treat tinnitus. In our proposed experiments, we have two parallel goals: (1) obtain investigational new drug (IND)-enabling toxicity and pharmacokinetics data for TET (Aim 1) and (2) optimize second-generation products with structure-activity relationship studies of TET and its chemical analogs (Aim 2). Successful accomplishment of Aim 1 will enable TET to advance into clinical development. In addition, the studies of Aim 2 will enable us to identify additional candidates in case TET fails at clinical stages. By targeting multiple cellular signaling pathways that impinge upon tinnitus, our study will open new areas for the treatment and prevention of tinnitus. The extensive body of data publicly available for TET and its analogs will help us significantly reduce development time and costs.

SOURCE: HHS Tracking Accountability in Government Grants System (TAGGS)

MORE INFORMATION:

From a U.S. patent assigned to Gateway Biotechnology…

In some cases, the therapeutically effective amount of TET or salt thereof is in a supplement product. In some cases, the therapeutically effective amount of TET or salt thereof is comprised in an herb extract. In some cases, the herb is Stephania tetrandra. In some cases, the herb is Stephania tetrandra S Moore. In some cases, the therapeutically effective amount of TET or salt thereof is isolated and purified. In some cases, the therapeutically effective amount of TET or salt thereof is a diastereoisomer having a diastereomeric excess of at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or from at least about 50% to about 100%.

SOURCE: https://patents.justia.com/patent/10434097

Gateway Biotechnology, Inc., a biotechnology company that repurposes drugs with established safety records to prevent and treat hearing disorders, today announced that is has been assigned U.S. patent number 10,434,097 to develop a compound isolated from a Chinese medicinal plant for the prevention and treatment of noise-induced hearing loss.

SOURCE: http://www.gatewaybiotechnology.com/blog/blog11/

FURTHER READING:

https://en.wikipedia.org/wiki/Stephania_tetrandra

https://pubmed.ncbi.nlm.nih.gov/10687873/


Developing story… more information about GW-201, tetrandrine (TET), and Stephania tetrandra will be added to this post…


This exclusive update is brought to you by Tinnitus Treatment Report. If you have a question, comment, or correction for this article, send an email to michael@urgentresearch.com and say hello. For email updates about GW-201, tetrandrine (TET), and other promising new treatments in the pipeline for tinnitus, subscribe.


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