Investigational BLD-2660 for Fibrosis Treatment Enters Phase 1 Trial, Blade Announces

Investigational BLD-2660 for Fibrosis Treatment Enters Phase 1 Trial, Blade Announces

Blade Therapeutics has launched a Phase 1 clinical trial to evaluate BLD-2660, its lead therapy candidate for the treatment of fibrosis, the company recently announced.

The randomized, placebo-controlled, dose-escalation Phase 1 trial (NCT03559166) is enrolling an estimated 88 healthy volunteers to assess the safety and pharmacokinetics — how the drug is absorbed, distributed, metabolized, and eliminated from the body  — of oral BLD-2660. It is currently recruiting participants.

“We are excited to initiate clinical development with BLD-2660. This represents a major milestone for the Company,” Wendye Robbins, MD, Blade’s CEO, said in a press release. “BLD-2660 has shown remarkable anti-fibrotic properties in multiple preclinical disease models. We believe it will be an effective treatment option with a favorable safety profile for patients suffering from debilitating fibrotic diseases.”

Fibrosis is a condition caused by the excessive formation and accumulation of connective tissue in an organ — also known as scarring — which can interfere with the organ’s normal structure and function.

Fibrosis can affect several organs, including the lungs, liver, and skin, and is often accompanied by local inflammation. As a result, several therapies aimed at controlling and reducing tissue inflammation have been developed in an effort to improve patients’ quality of life.

Interested in Pulmonary Fibrosis research? Check out our forums and join the conversation!

BLD-2660 is one such therapy in development. The compound is a highly selective inhibitor of calpains — a family of enzymes called proteases that play an important role in protein degradation and also regulate inflammation, cell migration, and other important processes.

In previous preclinical studies, BLD-2660 exhibited strong anti-fibrotic activity in multiple animal models of pulmonary, skin, and liver fibrosis. Moreover, biochemical analyses revealed that BLD-2660 had high metabolic stability and a favorable pharmacokinetic profile when administered orally or directly into the vein.

The trial will be conducted in Australia, with the first results expected by the end of 2018.

“By initiating the clinical trial in Australia, we are able to expedite our development timelines, work with top clinicians, and take advantage of favorable government rebates,” Robbins said. “We plan to file a U.S. Investigational New Drug Application (IND) with human safety and PK [pharmacokinetic] data by the end of the year, which we anticipate will allow us to move BLD-2660 into human proof-of-concept studies in 2019.”

13 comments

    • Joana Carvalho says:

      Hey Timothy,
      As far as I know, the trial will be running only in Australia for the time being. I am not sure if it will be expanded to the US later on, so I would recommend you to get in touch with the researchers involved in the study and ask them directly. I am sure they will be able to answer this and any other questions you might have.
      You can find their contact information here:
      https://clinicaltrials.gov/ct2/show/study/NCT03559166#contacts
      Wish you all the best.

  1. Rose Miller says:

    Hello,
    I am age 77 and in going into my 4th year of IPF since diagnosed at an early stage in 2015. If I am eligible for this trial and accepted, would I still be able to continue taking my OFEV twice daily?

    Thank you for your considertion
    Rose Miller
    [email protected]

    • Joana Carvalho says:

      Hello Rose,
      I am afraid you wouldn’t be eligible for this particular trial, because you are already exceeding the maximum age limit, which is 75.
      In any case, to answer your question: I didn’t see any topic in the exclusion criteria stating that patients with IPF won’t be allowed to take their usual medication during the trial.
      But to be sure, and for future reference, I would recommend you to get in touch with the researchers involved in the study and ask them directly. Usually you can find their contact information at the bottom of the page, like in this case:
      https://clinicaltrials.gov/ct2/show/study/NCT03559166#contacts
      Wish you all the best.

  2. Karmin Chowbay says:

    Am I eligible for this trial? I am 66 yrs old, diagnosed in 2016 with IPF taking OFEV since June of 2018.

    • Joana Carvalho says:

      Hello Karmin,
      Do you live in Australia? I am asking because as far as I know, the trial will be recruiting patients only in Australia for the time being.
      As for the rest, you are within the age interval eligible for the study. However, I am not sure if patients with IPF are allowed to take their usual medication during the trial, so I would recommend you to get in touch with the researchers involved in the study and ask them directly.
      You can find their contact information here:
      https://clinicaltrials.gov/ct2/show/study/NCT03559166#contacts
      Wish you all the best.

  3. Eleanor Demarzo says:

    I’m 67 years old I have a fibrosis of the lungs COPD emphysema but lately my oxygen level has been going low especially when I walk if I’m resting it’s fine it’s at 9293 is there any help I could get

    • Joana Carvalho says:

      Hi Eleanor,
      Are you taking any medication for your condition?
      This trial is recruiting healthy volunteers and patients previously diagnosed with lung fibrosis, which seems to be your case. If you live in Australia and you are interested in participating in this study, I would recommend you to get in touch with the researchers involved to know more details.
      You can find their contact information here:
      https://clinicaltrials.gov/ct2/show/study/NCT03559166#contacts
      Wish you all the best.

  4. Rhonda Battock says:

    HI i have systemic sceloderma sine and i live in New zealand but have a rhuematologist in Melbourne could i be a candidate for this drug trial.

    • Joana Carvalho says:

      Hi Rhonda,
      I am afraid you wouldn’t be eligible for this particular trial, because as far as I know, only healthy volunteers and patients with a diagnosis of lung or liver fibrosis are being recruited to the trial.
      In any case, to be sure, I would suggest you to get in touch with the researchers involved in the study and ask them directly.
      You can find their contact information here:
      https://clinicaltrials.gov/ct2/show/study/NCT03559166#contacts
      Wish you all the best.

      • Rhonda Battock says:

        maybe i could be a candidate in the next trial im going to talk it over with my rhuematologist i would love to help find a cure for systemic sceloderma it is one very cruel disease

Leave a Comment

Your email address will not be published. Required fields are marked *