Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense, announced today that it secured a $1.8 million Translation Fund Award supplement from the Wellcome Trust based on the positive Phase 1a clinical study results in healthy volunteers. This award will fund the Phase 1b multiple ascending dose (MAD) clinical trial and position LHF-535 for Phase 2 evaluation in Lassa fever patients where no approved treatment is currently available. The Wellcome Trust awarded Kineta with a Translation Fund Award of up to $7.2M in 2016 to advance the development of LHF-535 for the treatment of Lassa fever.
“We are encouraged by the favorable safety and pharmacokinetic data from the Phase 1a study that supports the continued development of LHF-535 as a potential oral treatment for patients with Lassa fever,” said Kineta CEO Shawn Iadonato. “The Wellcome Trust has been very supportive of our Lassa fever program and their continued support is further validation of this novel drug program.”
A phase 1a clinical study was conducted to evaluate the safety and pharmacokinetic profile of LHF-535 in healthy volunteers. A total of 48 volunteers across six cohorts were evaluated in a double-blind, placebo-controlled study. Each participant received a single oral dose of either placebo or active LHF-535 across six doses ranging from 0.3 to 40 mg per kg of body weight.
LHF-535 was safe and well tolerated with the frequency of treatment-related adverse events being similar across placebo and active LHF-535 participants with no dose relationship pattern. There was one moderate (grade 2) treatment-related treatment emergent adverse event, while all others were mild (grade 1). LHF-535 pharmacokinetics assessment demonstrated exposures predicted to be clinically efficacious.
A Phase 1b multiple ascending dose clinical trial will be initiated in Q3 2019 to further evaluate the safety and pharmacokinetic profile of LHF-535 in healthy volunteers. Earlier this year, Kineta announced that it received a grant of up to $5.8M from the National Institute of Allergy and Infectious Diseases (NIAID) to expand LHF-535 into additional potential arenavirus indications.
Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs. We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in oncology, neuroscience and biodefense. We actively collaborate with a broad array of private, government and industry partners to advance our innovative products. For more information on Kineta visit our website, www.kinetabio.com, follow us on Twitter at @kinetabio, LinkedIn and Like us on facebook.com/KinetaBio.
Lassa fever is an acute viral illness that is known to be endemic in West Africa. NIAID and CDC have identified it as a Category A pathogen that poses the highest risk to national security and public health. Lassa fever causes 100,000-300,000 infections and is responsible for ~5000 deaths annually in West Africa. Death rates are particularly high for women in the third trimester of pregnancy and fetal loss occurs in nearly all infected pregnant women. There is a significant unmet medical need as there are currently no therapeutics or vaccines that are indicated to treat Lassa fever.
LHF-535 is a first-in-class antiviral treatment with potent activity against Lassa and other arenaviruses. It inhibits virus entry into target host cells and serves to suppress viral replication. It has demonstrated safety and efficacy in preclinical models. In preclinical studies, LHF-535, reduced virus titers and provided complete survival when administered as a therapeutic in animals infected with Lassa. LHF-535 is a once daily oral therapeutic currently being evaluated in first-in-human Phase 1 safety studies. Kineta is receiving funding from the Wellcome Trust to advance LHF-535 through Phase I human safety studies and the National Institutes of Health to investigate broad activity against arenaviruses.
SOURCE Kineta, Inc.