Biotechnology company DiscGenics Inc reported on Monday the receipt of the US Food and Drug Administration (FDA) Fast Track designation for IDCT for the reduction in pain and disability associated with degenerative disc disease (DDD).

Chronic low back pain is a serious medical condition that represents a leading cause of disability worldwide and is the most common non-cancer reason for opioid prescription in the US.

IDCT, the company's allogeneic cell therapy, is currently being evaluated in regulator-allowed clinical trials in the US and Japan for the reduction in pain and disability associated with degenerative disc disease (DDD). It is conducting two parallel prospective, randomized, double-blinded, controlled, multicentre clinical trials in both the nations.

In the US, IDCT is being evaluated under an investigational new drug (IND) allowance by the Us FDA as a drug-biologic through a biologics license application (BLA). In Japan, the trial is supported by a Clinical Trial Notification (CTN) approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Primary outcome measures include safety and reduction in pain, said the company.

IDCT is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells, known as Discogenic Cells, which have been derived from intervertebral disc tissue to offer a non-invasive, potentially regenerative solution for mild to moderate DDD.

Additionally, IDCT is regulated by US FDA's Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health Service Act (PHSA). It is manufactured in a cGMP environment and is subjected to extensive testing, including identity, purity, potency and safety evaluation. For the commercial programme for IDCT, the company is in the process of scaling up its cGMP manufacturing process.