Clinical Trial Shows TD139 as a Promising Therapy Against Pulmonary Fibrosis, Maker Says

Clinical Trial Shows TD139 as a Promising Therapy Against Pulmonary Fibrosis, Maker Says

Clinical trial results indicate that inhaled TD139 is an effective, safe and well-tolerated treatment for idiopathic pulmonary fibrosis (IPF), its maker, Galecto Biotech AB, has reported.

The phase 1b/2a clinical trial (NCT02257177) was divided into two parts. Part 1 was a randomized, double-blind, single-center, placebo-controlled, single ascending dose phase 1 study. It assessed TD139’s safety, tolerability, pharmacokinetics, and pharmacodynamics in 36 healthy men.

Pharmacokinetics refers to how a drug behaves in the body, and pharmacodynamics to how the body reacts to a drug.

Part 2 was a randomized, double-blind, multi-center, placebo-controlled, multiple dose expansion study. It assessed TD139’s safety, tolerability, pharmacokinetics, and pharmacodynamics in 24 male and female IPF patients. The group received the drug or a placebo for two weeks.

A key finding was that TD139 had a favorable half-life, Galecto reported. The term refers to the amount of time it takes for a drug to lose half its strength in blood plasma.

The dose-proportional systemic exposure and absorption characteristics of the drug were also favorable, Galecto said. Dose-proportional exposure means that the higher the dose, the better the result. Absorption refers to how much of a therapy the body absorbs.

Read more about TD139.

TD139’s dose-proportional systemic exposure and absorption punch was particularly good in alveolar macrophages, one of the drug’s major targets, Galecto said. Alveolar macrophages are inflammatory cells that are believed to contribute to IPF.

The therapy was also well tolerated in all patients, Galecto said.

“TD139 has shown ground-breaking results in this proof of concept study in individuals with IPF, raising the prospect that this compound could represent an important future therapeutic option for this devastating disease,” Toby Maher, chief investigator of the trial, said in a press release. Maher is with the Royal Brompton Hospital and Imperial College in London.

“Galecto’s IPF trial has resulted in a paradigm shift for studying disease modifying agents for lung disease,” said Nikhil Hirani of the Edinburgh Medical School, the trial’s principal investigator. “By performing bronchoscopies before and after the treatment period, we have been able to detect biomarker changes in plasma and alveolar cells whilst also precisely quantifying the amount of TD139 that has reached the target cell. This has to my knowledge never been done before – neither with a potential IPF treatment nor with an inhaled drug of any kind.”

TD139 is an experimental inhalant for treating fibrosis, or the scarring in the lungs seen in IPF and other conditions. It works by inhibiting the galactoside binding pocket of galectin-3. Galectins are a family of proteins that bind to β-galactoside sugars, which are actively involved in disease mechanisms.

In preclinical studies, TD139 reduced fibrosis in organs and animal models.

“We are delighted to see the successful completion of this complex and pivotal clinical trial,” said Paul Ford, Galecto’s chief medical officer. “Given these unique results, they will pave the way for a phase 2b dose ranging study, which can be started in the near future.”

The company will present the trial results at a meeting of the American Thoracic Society in Washington in May.

“Galecto has transformed into a clinical stage company with a strong and deep portfolio in the fields of fibrosis, cancer and ophthalmology. Truly very exciting,” said Hans Schambye, MD, PhD, the company’s CEO.


  1. Maureen A Lake says:

    Are you looking for more participants in the study? I am from the US, 62yrs old, diagnosed thru high-resolution MRI 2yrs ago. I was on Esbriet for 1 year now trying Ofev. Had upper GI disturbance with each, lower with Ofev. I was hoping inhaled medication would be easier for me to tolerate.
    I am presently fairly stable with my IPF, being seen at Loyola by Dr. Daniel Dilling.

    • Tim Bossie says:

      Hi Maureen. Thank you for the question. It seems like you are doing fairly well and we are all happy about that. Please, talk with your doctor about this trial or have him contact the maker for any information of availability.

  2. Sally Simmonds says:

    Is there any way at all I can get into a free research program for IPF? I am a senior and am worried about the future and being able to afford what is necessary to keep me going.

    • Tim Bossie says:

      Hi Sally. We can not say for sure but it would be worth contacting the PF Assocation or talking with your doctor about options. Also, if there is a support group in your area they may be able to lead you in the right direction.

  3. Ray says:

    Should this help someone who has COPD. It sounds like it might reduce inflamation and allow the lungs to heal. Thank you. Sincerely, Ray

  4. Patty Doyle says:

    Just wondering if the participants in your study for TD139 had any side affects? I’ve been on OFEV for 22 mnths but have side affects which can be annoying.

  5. Patricia Heintzelman says:

    My father-in-law (79) has IPF and is not tolerating his medication very well. May we be notified of clinical trials that he may participate?

    Thank you so much

  6. Alfred Arnold says:

    Is TD139 closer to being approved to market in the US?
    I am 69 years old and have recently been diagnosed and confirmed via high resolution CAT scan.
    Will be starting Esbriet but would be more confident that an inhalation approach is more promising.

  7. Tedchester says:

    My Dad was part of the TD139 trial in the UK, one of only 24 patients. It was a 2 week trial to test for tolerance and NOT efficacy. Those that received the actual drug reported very minimal or no side effects and, after discussion at the annual American Thoracic Society Conference last May, it was agreed that the results overwhelmingly indicated that a trial to test efficacy should be considered. It’s all about funding now and, I guess, the race to see who gets there first. There are a few drugs being trialled and it’s all about which one seems the most likely to offer the greatest outcome for those with the disease. Knowing how long this process takes (Dad took part in the trial in September 2015) we are still some years from finding a drug which can stop this horrible disease. But we are slowly edging closer! Dad’s disease was thankfully diagnosed early and he has been on Pirfenidone since he completed the TD139 trial in 2015. His disease has not worsened since then, thanks to the Pirfenidone, and we remain hopeful that a cure will be found in the not too distant future, if not to reverse the disease, then hopefully capable of stopping progression.

    • Elvis p says:

      im having an ipf for 9months willing to vollunter trials td139 can you tell me where am i going to..pls, tell me the location

  8. Gary Sims says:

    My name is Gary Sims
    I’m 52 years old and have been diagnosed with pulmonary fibrosis 2 years ago.
    Judging by symptoms I’ve had the condition creeping up for many many years.
    I’m only on Betamethasone at the moment , and I’m told the condition is worsening.
    A transplant is being considered before it’s too late , but maybe I could access the new drugs available , maybe I could have free treatment as I’m a pharmacist and could give valuable feedback

  9. Helen Lamb says:

    I have very recently been diagnosed with pulmonary fibrosis this was a very worrying and shock diagnosis. I am an active 75 year old and keep myself fit. As a result of this I would be very willing to volunteer for any clinical trials (TD139) that are running. It sounds like TD139 is my and other sufferers hope for the future which can’t come soon enough.
    Thank you
    Helen UK

  10. Ron Stevens says:

    It’s wonderful to see that effort is being put forth to develop drugs that can stop the disease progression but even more importantly I am looking for these drugs that are showing the ability to reverse the disease something I have been told isn’t possible. However, we live in a world where everything is possible. The usual remedy is often transplant and that is a complicated and delicate undertaking. An effective and non-invasive remedy would be welcome.

  11. Ray Kimble says:

    Is this available at all, whether in a trial basis or approved for use in the U.S. My father is 80 years old, diagnosed with IPF five years ago and his condition is bad. He takes esbriet but it is no longer helping.

Leave a Comment

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