FDA grants Fast Track Designation to Polaryx Therapeutics’ PLX-200
Category: #health  | By Nikita Chaurasia  | Date: 2020-08-22 |
  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn

FDA grants Fast Track Designation to Polaryx Therapeutics’ PLX-200

Polaryx Therapeutics Inc., a biotechnology firm which develops small molecule therapeutics, has reportedly been granted approval by the U.S. FDA (Food & Drug Administration) of Fast Track Designation for analyzing the treatment option of JNCL/CLN3 (Juvenile Neuronal Ceroid Lipofuscinosis) patients with PLX-200.

For those uninitiated, JNCL/CLN3, which is caused by a Cln3 mutation, is a terminal genetic disorder pertaining to lysosomal storage. The incurable disease is typically indicated by progressive neurological deterioration, seizures, cognitive declines, and visual loss leading to blindness.

According to reliable sources, the Fast Track Designation program provides the FDA with greater access to the drug and further facilitates in conducting frequent audits. It also allows the FDA to expedite development of drug candidates which are being tested for the treatment of life-threatening and incurable ailments.

CEO and President of Polaryx Therapeutics, Dr Hahn-Jun Lee was reported stating that the company was looking forward to Fast Track designation program since frequent access of the FDA will help in accelerating the process of developing PLX-200 for the treatment of CLN3.

Sources close to the matter stated that the repurposed drug PLX-200 helps in improving the production of TFEB (transcription factor EB) by activating PPARα. The drug also apparently activates gene production which are required during lysosome biogenesis and therefore has therapeutic potential for lysosomal storage disorders such as JNCL/CLN3.

Chairman of Polaryx Therapeutics and CEO & President of Mstone Partners Alex Yang expressed that the company’s motivation towards initiating clinical trials to develop patient-friendly drugs and meet the medical needs of CLNR patients.

In other news, the U.S. Food and Drug Administration (FDA) reportedly flagged accuracy issues regarding the Thermo Fisher’s TaqPath genetic tests of COVID-19 virus. The warnings pointed out issues related to the software as well as laboratory equipment used for testing the virus.

Source Credits: https://www.prnewswire.com/news-releases/polaryx-therapeutics-receives-fda-fast-track-designation-to-plx-200-for-the-treatment-of-patients-with-juvenile-neuronal-ceroid-lipofuscinosis-301115070.html

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Nikita Chaurasia     twitter

Nikita Chaurasia

Having always been daft at wordplay, Nikita Chaurasia, post the completion of post-graduation, commenced her journey into the content generation cosmos. Endowed with a professional MBA degree in Advertising and Public Relations, Nikita strives to integrate her creativ...

Read More..

More News By Nikita Chaurasia

Samsung kickstarts chip production with 3nm process technology

Samsung kickstarts chip production with 3nm process technology

By Nikita Chaurasia

Samsung Electronics Co Ltd has reportedly declared that it has begun the mass production of chips using advanced 3-nanometre technology. The company is the first in the entire world to do so and is actively looking for new clients to contest with Tai...

Progcap nabs $40Mn in funding round for expansion & product development

Progcap nabs $40Mn in funding round for expansion & product development

By Nikita Chaurasia

Progcap, a pioneer in the field of corporate-driven financing solutions for small and medium-sized businesses (SMBs), has secured $40 million in private equity capital at $600 million valuation. The raised capital forms a part of the Series C exte...

Microsoft solidifies Qatar investment; Unveils new high-tech office

Microsoft solidifies Qatar investment; Unveils new high-tech office

By Nikita Chaurasia

Microsoft, the global tech behemoth, has recently stated that it is expanding its operation in Qatar by unveiling a new Lusail City unit, the firm’s largest and fourth in the country. This new facility forms part of a substantial investment tha...