Just the other day, Pliant Therapeutics announced that it would enact a strategic restructuring of its workforce in order to extend its cash runway. It intends to reduce its workforce by as much as 45% to implement this cost-cutting measure. This isn’t something that will happen immediately, though, because it notes that it won’t complete this particular process until the end of Q2 of 2025.
The reason for doing this is because the company wants to extend its cash runway as it advanced a few of its drug candidates from its pipeline. This is a bold move but a necessary one, as it will allow the company to focus its efforts on reaching data from its phase 2b/3 BEACON-IPF trial.
Speaking of which, this particular study is using the drug bexotegrast (dual selective inhibitor of αvβ8 and αvβ1 integrins) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis occurs as a result of scarring or damage of the liver that leads patients to have breathing issues. The nature of the term “idiopathic” means “no known cause.”
The company isn’t implementing this workforce reduction randomly out of nowhere. It is doing so because of a major roadblock it suffered back in March of 2025. At that time, it provided an update on this program, stating that it would discontinue the BEACON-IPF trial. The reason for doing so is because of the recommendation it had received from two particular bodies, which were the Data Safety Monitoring Board (DSMB) and an outside expert panel.
The thing is that the drug bexotegrast was actually helping these patients because it actually had an effect of improving forced vital capacity (FVC). A problem that these patients suffer from is scarred/stiff lungs, and they are not able to exhale as much air because of disease. Thus, these IPF patients suffer from low FVC. The point of this drug was to allow these patients to see an increase of this endpoint measure, which was happening.
The problem lies with adverse events noted between the patients who took the drug and those who took the placebo. This finding led both of the bodies noted above to recommend the discontinuation of the phase 2b/3 BEACON-IPF trial. There might still be a path forward here for the company depending on how good or bad the upcoming top-line data is that will be released from this study in the second quarter of 2025.
If the drug shows strong efficacy, then it is thinking about exploring several options, like doing additional dose-ranging phase 2b studies targeting patients with pulmonary fibrosis or other non-respiratory diseases. At least it has a few other drugs in place from its pipeline, just in case things don’t pan out with bexotegrast.
For example, it is evaluating the use of integrin αvβ8 and αvβ1 inhibitor PLN-101095 for the treatment of patients with advanced or metastatic solid tumors. However, to be more precise, these are patients who are immune checkpoint inhibitor (ICI) refractory in disease. In essence, drugs like KEYTRUDA from Merck or OPDIVO from Bristol-Myers Squibb don’t work alone for them as monotherapy.
What Pliant is doing is combining the use of PLN-101095 together with KEYTRUDA (pembrolizumab) to treat these patients with advanced or metastatic solid tumors. Things are going pretty well for this program based on what has been reported thus far. However, it is too early to say that this data is highly ideal until additional proof of concept is established.
In a phase 1 study that had completed 3 out of 5 dosing cohorts of oral PLN-101095 given twice daily (BID) in combination with KEYTRUDA, it was noted that 3 partial responses (PR) out of 6 patients were observed at the highest dose of 1,000 mg. This gives an initial objective response rate of 50%.
The reason why I state initial response is because there are other dosing cohorts to be tested. While there is no guarantee, it is possible that further responses could be achieved in them with higher dosing. Investors should keep an eye on this program, especially since the M.D. Chief Medical Officer of Pliant noted, “We look forward to sharing the final results from this trial in the future.” Further confirmation here would at least keep this company providing value to its shareholders even if the bexotegrast program is ultimately terminated.