vTv Therapeutics stock jumps on FDA orphan drug status

Investing.com -- vTv Therapeutics Inc (NASDAQ: VTVT) shares rose 6.4% in premarket trading Thursday after the company announced on Wednesday evening that the FDA granted orphan drug designation to HPPD, its oral Nrf2/Bach1 modulator being investigated as a treatment for sickle cell disease.

The designation reinforces the unmet need in sickle cell disease and strengthens the company's ability to advance strategic partnering discussions for HPPD, according to Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. The company continues to prioritize cadisegliatin, its lead late-stage type 1 diabetes program.

HPPD is an investigational, oral, first-in-class Nrf2/Bach1 modulator. Preclinical studies conducted at Augusta University using the Townes sickle cell disease mouse model showed that HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling.

Sickle cell disease affects approximately 100,000 people in the United States. The condition is characterized by chronic hemolytic anemia, recurrent vaso-occlusive pain crises, oxidative stress, progressive organ damage, and reduced quality of life.

The company is also developing cadisegliatin, a novel oral small-molecule glucokinase activator being investigated as a potential first-in-class adjunctive treatment for type 1 diabetes. Cadisegliatin has been granted Breakthrough Therapy designation by the FDA.

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