Anti Fibrotic LOXL2 Program Set To Commence Phase 1 Trials in Q4 2017
Pharmaxis has consolidated its position as a significant competitor in the NASH market as the LOXL2 inhibitor joins its SSAO inhibitor in the clinic. Pharmaxis and its collaborator UK biotechnology company Synairgen plc recently announced completion of the preclinical development stage of their anti-fibrotic Lysyl Oxidase type 2 (LOXL2) inhibitor program allowing the first compound to commence human clinical phase I studies in Q4 2017.
The Pharmaxis drug discovery group has developed a number of selective small molecule inhibitors to the LOXL2 enzyme utilising the same amine oxidase platform that delivered PXS-4728A, an anti-inflammatory drug that was acquired by Boehringer Ingelheim in 2015. The LOXL2 enzyme is fundamental to the fibrotic cascade that follows chronic inflammation in the liver disease NASH, cardiac fibrosis, kidney fibrosis, and idiopathic pulmonary fibrosis (IPF), and it also plays a role in some cancers.
The extensive pre‐clinical program performed on the program compounds confirmed that they have all the characteristics of a successful once a day, oral drug showing excellent efficacy in several different in vivo fibrosis models including fibrosis of the liver, lung, kidney and heart. In regulatory toxicity studies, our compounds have been well tolerated and shown a good safety profile.
NASH is a growing and valuable market for the future and we anticipate that our LOXL2 program will be attractive to many of the multinational pharmaceutical companies that are building a portfolio approach to treating NASH and some other fibrotic diseases such as IPF.
Boehringer Initiates a Phase 2a Study in Second Disease Indication for Drug Acquired from Pharmaxis in 2015
Boehringer Ingelheim and Pharmaxis have announced that Boehringer Ingelheim is initiating a Phase 2a study in diabetic retinopathy (DR) using orally administered BI 1467335 - a Pharmaxis drug discovery formerly known as PXS-4728A.
This new study is in addition to a phase 2a clinical trial commenced in the liver-related disease NASH in August 2017 - the start of which triggered a payment of a development milestone to Pharmaxis of approximately A$27 million.
Key points about the second study:
- DR is the leading cause of vision-loss in adults aged 20-74.
- Diabetic retinopathy is the second severe metabolic complication on top of non-alcoholic steatohepatitis (NASH) to be investigated for BI 1467335, which was acquired from Pharmaxis
- Pharmaxis will receive €10 million milestone payment when the first patient is dosed in this 2nd indication Phase IIa study.
- Boehringer Ingelheim’s holistic cardio metabolism R&D strategy reaches from risk factors, like obesity to complications, like NASH and DR
Details of the DR clinical trial can be found here.
Watch a 5 minute video with Pharmaxis CEO Gary Phillips discussing the clinical program with Boehringer: https://www.youtube.com/watch?v=OSB0fGkW5Kk
Pictured above : Pharmaxis CEO Gary Phillips and Boehringer Ingelheim MD Australia & NZ Wes Cook mark the start of a new clinical tril in diabetic retinopathy.
Pharmaxis Appoints Former Head of Global Research at Merck to Board of Directors
Pharmaxis has expanded its Board with a significant new appointment of internationally recognised executive Dr Kathleen Metters. Dr Metters has an impressive career spanning more than 25 years in the discovery and development of novel therapies for the treatment of serious diseases.
Dr Metters spent 9 years as a senior executive with Merck & Co. (Merck Sharp & Dohme, known as MSD outside the United States and Canada) which included senior executive roles leading work in global research, discovery and preclinical sciences.
In 2011 Dr Metters was appointed President and Chief Executive Officer for Lycera Corp., a biopharmaceutical company pioneering innovative approaches to novel oral medicines for treatment of autoimmune diseases and cancer. She is currently a senior advisor for Bridge Medicines where she is working to improve the translation and commercialisation of research in New York based academic institutions.
Dr Metters will serve as a Non-Executive Director on the Pharmaxis Board – joining current members Malcolm McComas, Simon Buckingham, Will Delaat and Gary Phillips.
Pharmaxis Chairman Malcolm McComas said, “The appointment of Dr Metters to the Pharmaxis Board follows a global search for a candidate who could contribute to the Pharmaxis business model of creating value through excellence in drug discovery and development. Her distinguished career in drug discovery inside a major multinational Pharma company and more recent role as a CEO of a smaller biotech company gives Dr Metters the experience and insight to make a significant contribution to Pharmaxis. We are delighted to welcome her to the Board at a time when we are making significant steps forward with our pipeline of anti-inflammatory and anti-fibrotic therapies and progressing our aim to building a globally competitive company.”