• NRX-101 demonstrated potent antibacterial effect against antibiotic-resistant pathogens in culture medium and in an artificial urine model
• D-cycloserine (DCS), a key component of NRX-101, was originally developed as an anti-infective in the 1950's but was replaced by antibiotics that have since lost effectiveness against complicated Urinary Tract Infections (cUTI)
• In an era when 90% of cUTI pathogens demonstrate resistance to standard antibiotics, NRX-101 may prove effective in treating cUTI and preventing urosepsis

D-cycloserine (DCS) was originally developed as an anti-infective in the 1950's but was never labeled for treatment of UTI, because of the prevalent and then-effective use of common antibiotics. In recent years, however, cUTI is increasingly caused by pathogens that are resistant to common antibiotics and are increasingly likely to cause sepsis, a lethal condition. Approximately 17,000 deaths per year in the United Statesare attributed to genitourinary sepsis.¹ The study, commissioned by NRx at Charles River Laboratories, is consistent with previously reported academic studies that demonstrate potency of DCS in antibiotic-resistant strains of urinary pathogens.

"These newly-obtained data from an internationally-recognized research organization demonstrate that NRX-101 has a potent level of in-vitro activity against dangerous pathogens, such as Pseudomonas and Acinetobacter. DCS was eclipsed by common antibiotics in the 1950s, partly because of the rarity of such pathogens at the time and the effectiveness of first and second generation antibiotics against the common urinary tract pathogens of the day. DCS additionally had an early history of causing mild hallucinations in some patients, although it remains widely used by the World Health Organization. In the studies conducted by NRx and others with DCS in combination with lurasidone and similar drugs, these CNS side effects have not been observed. At the same time, the fourth generation antibiotics that are now used to treat cUTI are increasingly associated with systemic side effects." said Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals, Inc.  "DCS has the advantage of being highly concentrated in the urine, suggesting that NRX-101 has potential to be developed as a safe and effective treatment of cUTI."

If successfully developed, NRX-101 could offer cUTI patients an effective therapy with a favorable safety profile. Because NRx has already completed the phase 3 manufacture of NRX-101, the Company is in a position to immediately seek investigational human use for this indication, while continuing to develop NRX-101 for suicidal depression and chronic pain.

Complicated UTI is increasingly common in the US, with an estimated 3 million new diagnoses annually.²  Antibiotic resistance is common as well.³  While the CNS effect of DCS is based on its inhibition of the brain's NMDA receptor, Cycloserine also inhibits cell-wall synthesis in various bacteria.