Bristol-Myers, Nordic Partnering on Development of Biomarkers for Fibrotic Diseases

Bristol-Myers, Nordic Partnering on Development of Biomarkers for Fibrotic Diseases

Bristol-Myers Squibb and Nordic Bioscience have agreed to work together to develop biomarkers for diagnosing and monitoring patients with fibrotic diseases, such as idiopathic pulmonary fibrosis (IPF).

IPF is a fatal, rare lung disease in which lung tissue and alveoli, tiny sacs in the lungs, become thick and scarred, or fibrotic. This ultimately compromises the transfer of oxygen between the lungs and bloodstream.

There is an urgent need for biomarkers that allow doctors to assess IPF activity and the disease’s response to treatments in clinical trials.

Nordic is a leader in developing, measuring, and validating the use of collagens, elastins and laminins as biomarkers of extracellular matrix activity.

The extracellular matrix consists of material that cells secrete to fill spaces between themselves and other cells. It includes proteins known as collagens, elastins, laminis, reticulins, glycoproteins, proteoglycans, and osteopontin.

Nordic invented a biomarker called C-terminal telopeptide (CTX), which can identify patients with osteoporosis who have a high rate of bone loss. CTX is also used to evaluate patients’ response to therapy.

“Addressing the significant need for better diagnostic and monitoring tools in fibrotic diseases is a key element of Bristol-Myers Squibb’s fibrosis strategy to help patients suffering from these debilitating conditions,” Mike Burgess, head of the company’s cardiovascular, fibrosis and immunoscience development arm, said in a press release.

“We continue to invest in innovative approaches to develop more precise methods to diagnose disease and monitor progression, and we are pleased to partner with Nordic Bioscience and leverage their vast experience in biomarker development,” Burgess added.

Under the agreement, the companies will also work together to develop biomarkers for another fibrotic disease, nonalcoholic steatohepatitis, or NASH. It is caused by liver inflammation that stems from a build-up of fat in the liver. No approved treatments exist for it.

“There is a big unmet need in medical and drug development for simple non-invasive diagnostic, early proof of efficacy of intervention and prognostic biomarkers in the NASH field. Nordic Bioscience is very proud to enter into this collaboration which will benefit the fibrosis field by advancing the research in fibrosis biomarkers for the benefit of patients,” said Nordic CEO Morten Karsdal.

 

One comment

  1. Ric Ellens says:

    FDA CONFIRMS PROMETIC’S PBI-4050 IPF CLINICAL TRIAL DESIGN

    FDA concurs with add-on placebo controlled phase 2/3 clinical trial for PBI-4050 in combination with nintedanib
    Prometic to also conduct placebo controlled phase 2/3 PBI-4050 Monotherapy clinical trial
    LAVAL, QUEBEC, CANADA, – April 18, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic” or the “Corporation”) announced today that it has received concurrence from the US Food and Drug Administration (“FDA”) on the design of the first of its PBI-4050’s planned phase 2/3 clinical trials for IPF based on the efficacy data generated in the recently completed 40 patient Phase 2 open-label study.
    In that phase 2 study, PBI-4050 was given for 12 weeks to patients who were receiving pirfenidone, nintedanib, or neither agent. The results of the study showed that the Forced Vital Capacity (FVC) remained stable in patients on PBI-4050 alone (n=9, FVC -12 ml) or in patients on PBI-4050 in combination with nintedanib (n=15, FVC +2 ml). In contrast, the results of said study showed that the FVC declined significantly in patients on PBI-4050 in combination with pirfenidone (n=16, FVC -105 ml). PBI-4050’s plasma concentration was sub-therapeutic at 50% of the expected level in patients that received the PBI-4050 and pirfenidone combination, suggesting a drug-drug interaction.
    Dr. John Moran, Chief Medical Officer of Prometic commented: “This early evidence of efficacy observed with PBI-4050 alone or in combination with nintedanib points toward very promising treatment options that will be further tested in two separate phase 2/3 clinical trials. We are very pleased that the FDA concurs with our decision to exclude a combined pirfenidone and PBI-4050 treatment arm in the upcoming phase 2/3 add-on study”.
    The design for the add-on placebo-controlled phase 2/3 pivotal trial will therefore be an amended version of the protocol the FDA originally requested during the pre-IND meeting: IPF patients currently treated with nintedanib would be randomized to receive in addition either PBI-4050 or a placebo.
    Prometic also intends to initiate a second phase 2/3 placebo-controlled trial which would enroll IPF patients who have failed to tolerate nintedanib or pirfenidone and would be randomized to receive either PBI-4050 or placebo, (“PBI-4050 Monotherapy”).
    “To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout all clinical trials”, said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. “We are also very pleased that our phase 2 open label study in IPF patients has served the very important strategic purpose of allowing us to optimize the design of our pivotal clinical program for this devastating medical condition”.

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