Lpathomab is well-tolerated at all doses tested in healthy volunteers
SAN DIEGO, CA, USA I February 1, 2016 I Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced today completion of dosing in its Phase 1a double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Lpathomab™ in healthy volunteers. Lpathomab has been well tolerated at all doses tested, and no serious adverse events or dose limiting toxicities have been observed to date.
Lpathomab is a humanized monoclonal antibody targeting the bioactive lipid, lysophosphatidic acid (LPA), which has been shown in the literature to be important in conditions of neuronal injury, such as neuropathic pain-related indications.
Lpathomab was administered in five different ascending dose cohorts at 0.5, 1.0, 3.0, 10.0 and 20.0 mg/kg. All 36 subjects, including those who received placebo, successfully completed dosing with a single intravenous infusion as planned. Complete pharmacokinetic and safety follow up data are anticipated to be available by April, 2016.
“We are very pleased that in this first-in-human study, Lpathomab appears to be safe and well-tolerated at doses as high as 20 mg/kg,” commented Dario Paggiarino, M.D., Lpath’s senior vice president and chief development officer. “Neuropathic pain is an area where the side effect profile of existing drugs is often so debilitating that the patients can’t continue their treatment regimens. The fact that Lpathomab appears to be well-tolerated further underscores the potential value of our product candidate with a novel mechanism of action.”
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN) is the category leader in lipid-targeted therapeutics. The company’s ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind and inhibit bioactive lipids that contribute to disease. The company has developed four drug candidates, has advanced the first two to mid-stage trials and built evidence to support its approach of targeting bioactive lipids to treat a wide range of diseases. For more information, visit www.lpath.com.
SOURCE: Lpath
Post Views: 156
Lpathomab is well-tolerated at all doses tested in healthy volunteers
SAN DIEGO, CA, USA I February 1, 2016 I Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced today completion of dosing in its Phase 1a double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Lpathomab™ in healthy volunteers. Lpathomab has been well tolerated at all doses tested, and no serious adverse events or dose limiting toxicities have been observed to date.
Lpathomab is a humanized monoclonal antibody targeting the bioactive lipid, lysophosphatidic acid (LPA), which has been shown in the literature to be important in conditions of neuronal injury, such as neuropathic pain-related indications.
Lpathomab was administered in five different ascending dose cohorts at 0.5, 1.0, 3.0, 10.0 and 20.0 mg/kg. All 36 subjects, including those who received placebo, successfully completed dosing with a single intravenous infusion as planned. Complete pharmacokinetic and safety follow up data are anticipated to be available by April, 2016.
“We are very pleased that in this first-in-human study, Lpathomab appears to be safe and well-tolerated at doses as high as 20 mg/kg,” commented Dario Paggiarino, M.D., Lpath’s senior vice president and chief development officer. “Neuropathic pain is an area where the side effect profile of existing drugs is often so debilitating that the patients can’t continue their treatment regimens. The fact that Lpathomab appears to be well-tolerated further underscores the potential value of our product candidate with a novel mechanism of action.”
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN) is the category leader in lipid-targeted therapeutics. The company’s ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind and inhibit bioactive lipids that contribute to disease. The company has developed four drug candidates, has advanced the first two to mid-stage trials and built evidence to support its approach of targeting bioactive lipids to treat a wide range of diseases. For more information, visit www.lpath.com.
SOURCE: Lpath
Post Views: 156
