On November 15, 2018, Pharmaxis Limited (ASX: PXS) announced about the Phase 1 clinical trial results. The trial was done to study the outcome from the inhibitor compound LOXL2 (Lysyl Oxidase Like 2) that is used for the treatment of fibrotic diseases such as NASH (Non-Alcoholic Steatohepatitis) and IPF (Idiopathic Pulmonary Fibrosis).Â
The study was divided in two stages. The first stage was conducted on 48 healthy patients who were divided in six groups, with each patient given a single dosage ranging from 5mg to 200 mg or placebo. The second group was having 24 healthy patients who were divided in three groups with each one receiving single dosage of either 50mg, 100mg, 200mg or they were given placebo for 14 days.
On October 10, 2018. PXS has announced the Phase1 trial results of the first inhibitor compound. The results presented were highly positive from the Phase1 trial, confirming with the pre-clinical testing that were conducted earlier. Both the first and the second stages of the study showed nil adverse safety findings and the pharmacokinetic profile showing the expected dose relates to increase in exposure.
LOXL2 enzyme recorded significant target engagement from the two compounds has been very well noticed in blood serum for a full 24 hours with the application of single dosage for a 14-day period. The second compound achieved more than 85% of inhibition over a period of 24 hours with the application of 100 mg dose on daily basis and very well achieved the set target for the program.
CEO Gary Phillips while addressing the media mentioned that several leading players in pharma space are showing interest in the ongoing programs of Pharmaxis, where both of LOXL2 inhibitors have successfullyÂ completed the phase1 study process and has well displayed, best in class results with the inhibition of the target enzyme from a single dose for 24 hour period. The company has well managed to explain the significance of such programs to their potential partners with the help of their proprietary research tools that helps in confirming that the compounds directly impact the activity of the raised level of LOXL2 which is noticed in diseased tissue from NASH and IPF animal type.
He further said, that the only thing that is required for the finalization of the data package upon which the due diligence is being conducted by the companies is the report on 3-month toxicity study conducted on both compounds, and which is due for release later in this quarter.
The release of the report is slightly delayed from its initial expected date. Strong outcome from the 3-month studies will enhance the LOXL2 program. The company will conduct series of scientific briefings before it steps towards discussions for commercialization and securing comprehensive licensing agreement in 2019.
Positive resultsâ impact was well seen on share price move which rallied by 1.9% and closed at the levels of $0.265.
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