“We remain committed to advancing our arginase inhibitor clinical development program to fully explore the potential of this new class of therapeutics in a variety of conditions,” said
Research in CF patients has demonstrated that increased arginase activity correlates directly with worsened lung function, and reduced expiratory nitric oxide (NO) levels. Pre-clinical studies conducted by Calithera and collaborators have shown that arginase inhibition increases systemic arginine levels, decreases airway bacterial colonies, and improves lung function in CF mouse models of infection. Inhibiting arginase may reduce infection and improve lung function in people with CF. Chronic poly-microbial infection remains a major area of unmet need in CF.
The Phase 1b randomized, double blind, placebo-controlled, dose escalation trial will evaluate multiple ascending doses of CB-280 compared to placebo in 32 adult CF patients to determine a safe dose range for CB-280, dosed orally twice daily for 14 days. The study follows the completion of a Phase 1 trial that evaluated the safety, tolerability and pharmacokinetic profile of CB-280 in healthy volunteers, which was conducted under a United States Food and Drug Administration Investigational New Drug (IND) application.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of the arginase inhibitor CB-280 in adult patients with cystic fibrosis, the overall advancement of CB-280 in the Phase 1b clinical trial , the unmet need in the treatment of patients despite recent therapeutic advancements, Calithera’s global collaboration with Incyte, and Calithera’s plans to continue development of CB-280. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's most recent Quarterly Report on Form 10-Q filed with the
SOURCE: Calithera Biosciences, Inc.
Source: Calithera Biosciences, Inc.