Kineta focuses on extending the clinical trials with LHF-535 into Phase 1b MAD clinical trials based on the positive Phase 1a clinical study results in healthy volunteers.
FREMONT, CA: Kineta, Inc., a clinical-stage biotechnology company, dedicated to developing novel life science technologies for immunotherapies in oncology, neuroscience, and biodefense acquires 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 that is to commence in Q3 of 2019. It will further advance LHF-535, a first-in-class antiviral treatment with potent activity against Lassa and other arenaviruses for Phase 2 evaluation in Lassa fever patients.
Lassa fever is an acute viral illness that can cause 100,000-300,000 infections and is known to be endemic in West Africa. Currently, there are no therapeutics or vaccines that can potentially treat Lassa fever. LHF-535 is identified as an oral treatment for Lassa fever and is being evaluated in first-in-human Phase 1 safety studies.
The Phase 1a clinical study is conducted to analyze the safety and pharmacokinetic profile of LHF-535 in healthy volunteers. A total of 48 volunteers across six cohorts participated in the clinical studies, and they were subjected to a double-blind, placebo-controlled study. Each participant is administered with an oral-dose of either placebo or active LHF-535 across six doses that range between .03 and 40mg per kg of body weight. From the observations, LHF-535 was safe and tolerable with the same frequency of treatment-related adverse events in participants involved in placebo. In the studies conducted, there was one moderate (grade 2) treatment-related emergent adverse event, while all others were mild (grade 1). In preclinical studies, LHF-535 administered for therapeutic purposes reduced virus titers and ensured complete survival of animals infected with Lassa.
It is expected that a Phase 1b MAD clinical trial will be initiated in 2019 Q3, following the Phase 1a clinical trials to further evaluate the safety and pharmacokinetic profile of LHF-535 in healthy volunteers. Also earlier this year, Kineta has acquired a fund award of $5.8 million from the National Institute of Allergy and Infectious Diseases (NIAID) to expand the clinical trials with LHF-535 into other serious indications associated with arenavirus.
“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 Welcome Trust has been very supportive of our Lassa fever program and their continued support is further validation of this novel drug program.”