LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biopharmaceutical company, announced promising preclinical data for its novel type 2 Natural Killer T (NKT) cell activators, GRI-0803 and GRI-0124, in the treatment of systemic lupus erythematosus (SLE). The findings were presented at the 14th International Congress on Autoimmunity.
The company's second asset in development, GRI-0803, has been observed to inhibit both murine and human invariant NKT (iNKT) cells, which are critical in the progression of inflammatory and fibrotic diseases. Preclinical studies indicate that oral administration of GRI-0803 significantly improved overall survival and reduced disease symptoms in models of lupus nephritis.
Dr. Vipin Kumar Chaturvedi, Chief Scientific Officer at GRI Bio, noted the substantial need for effective SLE treatments, as current options are mostly limited to immunosuppressive therapies. He expressed optimism about the potential of GRI-0803 and GRI-0124 to interrupt disease progression by targeting earlier in the inflammatory cascade.
GRI Bio aims to file an Investigational New Drug (IND) application for GRI-0803 in the second half of 2024, with topline data expected by the fourth quarter of the same year. The company is currently validating bioanalytical methods, completing cGMP manufacturing, and conducting toxicology studies.
The preclinical data also showed that type 2 NKT cells accumulate in the kidneys of NZBWF1 mice, a common model for human lupus, and that activation of these cells inhibits iNKT cell activity. GRI-0124, administered once weekly, led to decreased pro-inflammatory cytokines, reduced renal cellular infiltration, and inhibited proteinuria.
GRI Bio's lead program, GRI-0621, is an inhibitor of iNKT cell activity being developed as an oral therapeutic for idiopathic pulmonary fibrosis.
The company's pipeline includes over 500 proprietary compounds with the potential to treat a range of inflammatory, fibrotic, and autoimmune diseases.
This news is based on a press release statement from GRI Bio, Inc. The company cautions that forward-looking statements within the release are subject to uncertainties and risks, and there is no guarantee that future results will match those in preclinical studies.
InvestingPro Insights
As GRI Bio, Inc. (NASDAQ: GRI) continues to progress in its preclinical studies, the company's financial health and market performance provide additional context for potential investors. According to recent data from InvestingPro, GRI Bio's market capitalization stands at a modest 1.37 million USD, reflecting the company's current valuation within the biopharmaceutical industry.
Notably, GRI Bio has been facing significant challenges, as evidenced by a substantial decline in its stock price over various time frames. The company's stock has experienced a one-year price total return of -99.01%, highlighting the volatility and investor sentiment surrounding the stock. In the short term, the one-month price total return shows a decrease of -18.55%, which aligns with the InvestingPro Tip that the stock has fared poorly over the last month.
Moreover, GRI Bio's financial metrics indicate that it is not profitable over the last twelve months, with a negative return on assets of -474.16%. This data point, along with the fact that the company is quickly burning through cash, suggests that GRI Bio may need to secure additional funding or partnerships to continue its research and development efforts effectively.
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