Spero Therapeutics Inc (NASDAQ:SPRO) just announced results from preclinical IND-enabling studies of SPR720, an oral antimicrobial agent being developed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.
According to the release, “The preclinical in vitro and in vivo toxicology studies demonstrate that SPR720 achieved wide therapeutic margins and activity versus multiple clinically important species of non-tuberculous mycobacteria, which Spero believes supports its advancement into human clinical trials.”
Spero Therapeutics Inc (NASDAQ:SPRO) bills itself as a clinical-stage biopharmaceutical company that focuses on identifying, developing, and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections in the United States.
Its product candidate includes SPR994, an oral carbapenem-class antibiotic to treat MDR gram-negative infections for adults; and SPR741, which is in Phase Ib clinical trial to treat MDR gram-negative infections in the hospital setting.
The company also develops SPR206, an agent that is in preclinical development stage to disrupt the outer membrane of gram-negative bacteria; SPR720, an oral antibiotic, which is in preclinical development stage for the treatment of pulmonary non-tuberculous mycobacterial infections.
Spero Therapeutics, Inc. was founded in 2013 and is headquartered in Cambridge, Massachusetts.
SPR720 represents a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication. SPR720 was in-licensed from Vertex and is being developed as an oral therapy for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections. NTM are ubiquitous environmental pathogens that can cause progressive lung damage and respiratory failure, particularly in patients with compromised immune systems or underlying pulmonary disorders.
Although rare, the incidence of pulmonary NTM infections is increasing worldwide. Treatment of pulmonary NTM infections requires prolonged therapy (continuing for approximately 12 to 24 months) with a combination regimen and is frequently complicated by tolerability and/or toxicity issues. Additionally, there are currently no oral antibiotics specifically approved for use to treat pulmonary NTM infections. Thus, if successfully developed, SPR720 has the potential to address an important unmet need as the first oral antibiotic approved for the treatment of this debilitating disease. Pre-clinical in vitro and in vivo studies have demonstrated potency for SPR720 against a range of bacteria that cause pulmonary NTM infections, including Mycobacterium avium complex and Mycobacterium abscessus, a highly resistant strain responsible for high mortality. Spero believes that its intellectual property portfolio for SPR720 will provide protection globally, including in the United States and Europe, through 2033.
Are We There Yet?
We started off by noting that SPRO just hit the wires with the announcement results from preclinical IND-enabling studies of SPR720, an oral antimicrobial agent being developed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.
SPRO has responded well, rallying about 5% over the past five days, with this news clearly driving the action. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -18%.
“With these encouraging results, we look forward to advancing SPR720 into the clinic in early 2019,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “SPR720 offers the potential to address an important unmet need as the first oral agent for the treatment of pulmonary NTM, a chronic debilitating disease with limited treatment options.”
Spero Therapeutics Inc (NASDAQ:SPRO) pulled in sales of $463K in its last reported quarterly financials, representing top line growth of -59.8%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($66.6M against $6.6M).