Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with fibrotic diseases, today announces the acquisition of OccuRx, a Melbourne-based biotechnology company with highly complementary assets, resources and expertise, and a shared focus on targeting GPR68, a master switch of fibrosis.

The acquisition combines the assets and capabilities of two companies founded by a leader in the GPR68 field, Professor Darren Kelly, consolidating a pipeline that now includes two Phase 2 and one Phase 1 clinical candidates. Building on Professor Kelly’s pioneering research into inhibitors of GPR68 and benefiting from years of further development within biotechnology and major pharma companies, Certa’s pipeline aims to tackle fibrotic diseases upstream of other targeted biological pathways.

Certa’s lead programme is asengeprast (FT011) a novel, first-in-class oral therapy for the treatment of chronic fibrosis in multiple organs, which has shown favourable efficacy, safety and pharmacokinetics in patients with systemic sclerosis (scleroderma or SSc). Post the acquisition, Certa’s pipeline will include the additional asset OCX063 from OccuRx which has successfully completed a Phase 1 clinical trial and is in development for focal segmental glomerulosclerosis (FSGS), a rare disease characterized by fibrosis developing in the kidney glomerulus. In addition, Certa also has CTA382, a second-generation compound with the same chemical backbone as Asengeprast, that is under development to treat chronic kidney disease and a third-generation series of pre-clinical GPR68 antagonists, based on a different chemical backbone. Assets from this series are being developed for other fibrotic conditions and wider therapeutic indications.

Professor Darren Kelly, Certa Therapeutics’ CEO and founder, said, “Fibrotic diseases are an area of significant unmet need, responsible for an estimated 45% of all deaths globally and representing a $15 billion market. We believe GPR68 is a critical ‘master switch’ of fibrosis and through this acquisition we have brought together a unique pipeline and a passionate, experienced team which is uniquely equipped to drive its development. We look forward to rapidly advancing our programs and, ultimately, developing new safe, effective precision therapies for patients.”

Asengeprast has its genesis in Fibrotech, which was sold to Shire in 2014. When Shire was then acquired by Takeda in 2018, Brandon Capital Partners and Uniseed had an opportunity to reinvest in the asengeprast clinical program by forming Certa Therapeutics, and to develop GPR68-targeting ophthalmology assets by forming OccuRx. The two companies have raised $30m (AU$44.5m) over the past six years to advance these assets. Certa will now seek to raise a series B to continue the clinical development of its pipeline and expand its operations.

Dr Chris Nave, chair of Certa Therapeutics and Managing Partner of lead investor Brandon Capital, said, "Bringing together the assets and expertise of Certa Therapeutics and OccuRx under one company creates a powerful platform to advance transformative therapies for fibrotic diseases. This consolidation reinforces Certa’s leadership in the GPR68 field and its commitment to developing innovative treatments with a promising clinical-stage pipeline of GPR68 antagonists.”

For further information please contact

Media – AustraliaKirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228

Media - InternationalSue Charles, Charles Consultants E: sue.charles@charles-consultants.com M: +44 (0)7968 726585

About Certa TherapeuticsCerta Therapeutics is a clinical-stage biotechnology company pioneering innovative precision therapies for the treatment of fibrotic diseases—an area of significant unmet need, responsible for an estimated 45% of all deaths globally and representing a $15 billion market. Certa’s platform targets a critical 'master switch' of fibrosis, GPR68 (a defined G protein-coupled receptor (GPCR)), with a pipeline of inhibitors for various fibrotic indications.

Asengeprast (FT011), the company’s lead program, is being developed as a novel, first-in-class oral therapy for systemic sclerosis (scleroderma, SSc) and has successfully completed a multi-national, phase II clinical trial. Scleroderma is a potentially-life threatening autoimmune disorder with the highest mortality rate among rheumatic diseases. The FDA has granted asengeprast (FT011) Orphan Drug Designation and Fast Track status for SSc. Certa's pipeline includes further programs targeting major indications such as chronic kidney disease, focal segmental glomerulosclerosis, diabetic nephropathy, and other chronic fibrotic conditions.

Based in Melbourne, Australia, Certa is supported by venture investors Brandon Capital and Uniseed.

More information at https://certatherapeutics.com/

Follow us on LinkedIn: https://www.linkedin.com/company/certa-therapeutics/