Complexa has obtained $62 million in financing to continue advancing its pulmonary arterial hypertension therapy CXA-10 through the clinical trial process.
The company is also developing CXA-10 as a treatment for kidney disease focal segmental glomerulosclerosis, or FSGS.
Companies that participated in Complexa’s third round of financing included New Enterprise Associates, Pfizer Venture Investments, Edmond de Rothschild Investment Partners, HBM Healthcare Investments, and JAFCO.
Complexa developed CXA-10 to regulate signals triggered by the proteins Nrf2 and NF-κB. Those signals play key roles in fibrotic — or tissue-scarring — processes and in inflammatory mechanisms.
CXA-10 belongs to a class called nitro fatty acids that regulate signaling mechanisms.
“This financing enables Complexa to advance CXA-10, the first drug candidate from our novel nitrated fatty acid platform, into Phase 2 trials,” Josh Tarnoff, president and chief executive officer of Complexa, said in a press release. “We are honored to have this sophisticated group of investors help build Complexa as we test CXA-10 in these two proof-of-concept trials, and appreciate the continued confidence that JAFCO and other existing investors have shown with their participation.”
Preclinical-trial studies have demonstrated that CXA-10 can increase levels of the anti-inflammatory protein Nrf2 while inhibiting the inflammatory signaling molecule NF-kB.
Phase 1 clinical trials involving more than 100 healthy volunteers confirmed how CXA-10 works and showed it to be safe. The trials also demonstrated that the drug could regulate key fibrosis and inflammation biomarkers.
“CXA-10 is a highly differentiated agent that has the potential for disease-modifying effects in inflammatory conditions such as FSGS and PAH [pulmonary arterial hypertension], in which many patients fail to respond to existing treatment options,” Tarnoff said.
One of the clinical trials that the additional financing will cover will be a Phase 2 study of CXA-10’s effectiveness against FSGS, which Complexa plans to start in the beginning of 2018. Another study it plans to start in the first half of 2018 is a Phase 2 trial of oral CXA-10 as a disease-modifying treatment for PAH patients.
“We strive to invest in compounds that have the potential to change the treatment paradigm in indications with high unmet need,” said Dr. Sara Nayeem, a partner at New Enterprise Associates.
“Upregulation [increased production] of Nrf2 is a validated mechanism in PAH, while inhibition of NF-κB is essential to the effects of steroids in FSGS,” she said. “In combining these proven mechanisms of action, Complexa’s CXA-10 may offer the key to halting inflammation and repairing damage in hard-to-treat inflammatory conditions.”
She added that her company is “pleased to contribute as a partner to help build” Complexa.
Complexa is adding Nayeem to its board, along with David Mott, head of New Enterprise Associates’ healthcare practice; Dr. Barbara Dalton, vice president of venture capital at Pfizer Venture Investments; and Gilles Nobécourt, a partner at Edmond de Rothschild Investment Partners. Board members that Complexa is retaining include Tarnoff, Dr. Kenji Harada of JAFCO, and I. Wistar Morris.