false 0001746473 0001746473 2024-05-14 2024-05-14

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2024

 

 

PLIANT THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-39303   47-4272481

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

260 Littlefield Avenue,

South San Francisco, CA

  94080
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 481-6770

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   PLRX   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 8.01

Other Events.

On May 14, 2024, Pliant Therapeutics, Inc. (the “Company”) announced topline data from a 12-week, randomized, double-blind, placebo-controlled trial of bexotegrast (PLN-74809) conducted at Massachusetts General Hospital evaluating change in total collagen levels in the lungs of patients with idiopathic pulmonary fibrosis (“IPF”). IPF is a disease characterized by excessive collagen deposition in the lung. Bexotegrast-treated patients showed reduced total lung collagen post treatment as measured by positron emission tomography (“PET”) imaging, compared to increased total lung collagen in the placebo group, suggesting potential reversal of fibrosis. Bexotegrast-treated patients demonstrated improvements in forced vital capacity and reduction in cough severity across all timepoints compared to placebo. Bexotegrast 160 mg was well tolerated over 12 weeks with no drug-related serious adverse events and no discontinuations. A copy of the Company’s press release, titled “Pliant Therapeutics Announces Positive Topline Data from a Phase 2a Collagen PET Imaging Clinical Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis,” is attached as Exhibit 99.1 to this Current Report and is incorporated by reference herein.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

No.

   Description
99.1    Press Release, dated May 14, 2024, titled “Pliant Therapeutics Announces Positive Topline Data from a Phase 2a Collagen PET Imaging Clinical Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis.”
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  PLIANT THERAPEUTICS, INC.
Date: May 14, 2024   By:  

/s/ Keith Cummings

    Keith Cummings, M.D., MBA
    Chief Financial Officer

Exhibit 99.1

 

LOGO

Pliant Therapeutics Announces Positive Topline Data from a Phase 2a Collagen PET Imaging Clinical

Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis

12-week treatment with Bexotegrast 160 mg resulted in reduction of total lung collagen

as measured by PET imaging, compared to an increase on placebo

Improvement in FVC and reduction in cough severity reported in bexotegrast-treated patients

at all timepoints compared to placebo

Bexotegrast 160 mg was well tolerated over 12 weeks of treatment

with no serious adverse events and no discontinuations

SOUTH SAN FRANCISCO, CA., May 14, 2024 – Pliant Therapeutics, Inc. (Nasdaq: PLRX), today announced topline data from a 12-week, randomized, double-blind, placebo-controlled trial of bexotegrast (PLN-74809) conducted at Massachusetts General Hospital evaluating change in total collagen levels in the lungs of patients with idiopathic pulmonary fibrosis (IPF). IPF is a disease characterized by excessive collagen deposition in the lung.

Bexotegrast-treated patients showed reduced total lung collagen post treatment as measured by positron emission tomography (PET) imaging, compared to increased total lung collagen in the placebo group, suggesting potential reversal of fibrosis. Bexotegrast-treated patients demonstrated improvements in forced vital capacity (FVC) and reduction in cough severity across all timepoints compared to placebo. Bexotegrast 160 mg was well tolerated over 12 weeks with no drug-related serious adverse events (SAEs) and no discontinuations.

The trial evaluated bexotegrast at a once-daily dose of 160 mg versus placebo, and measured change in total lung collagen in 10 patients with IPF after 12 weeks of treatment. Patients underwent PET imaging with a collagen-binding radiotracer at baseline and Week 12.

The trial enrolled 7 patients in the active arm and 3 in the placebo arm. Eight out of 10 enrolled patients were on standard of care with the majority of those on nintedanib.

Bexotegrast 160 mg-Treated Patients Showed Reduced Total Lung Collagen Levels After 12 Weeks of Treatment, Suggesting Potential Reversal of Fibrosis

The primary endpoint of the trial was an evaluation of the change in standardized uptake value (SUV) of 68GA-CBP8, a PET ligand that binds to type 1 collagen. Type 1 collagen is the predominant collagen type produced in the lungs as a result of IPF.1 An increase in SUV of in the lung indicates increased total lung collagen and potential progression of disease. IPF patients have been shown to exhibit higher SUV values compared to healthy subjects.2 Additionally, patients with increased total lung collagen as measured by PET imaging had an increased risk of death.3

 

1 

Kuhn C 3rd, et al. 1989. Am Rev Respir Dis. Dec;140(6):1693-703.

2 

Montesi SB, et al. 2019. Am J Respir Crit Care Med 200:258–261.

3 

Justet, A. et al. 2017. Respir Res 18, 74.


After 12 weeks of treatment, bexotegrast-treated patients showed a reduction in SUV in the lung compared to an increase seen in placebo. This reduction in SUV indicates reduced total lung collagen in the treated group, suggesting potential reversal of fibrosis.

 

LOGO

Figure 1. Mean Change from Baseline in Uptake of Collagen PET Tracer After 12 Weeks

Bexotegrast-Treated Patients Demonstrated Improvements in FVC, Cough Severity, and Fibrosis Biomarkers Across All Time Points

The trial’s exploratory efficacy endpoints assessed changes in FVC, forced vital capacity percent predicted (FVCpp), patient reported cough severity, and fibrosis biomarkers. Bexotegrast-treated patients experienced improved lung function, as measured by FVC and FVCpp, with a clear separation from placebo across all timepoints.

 

LOGO

Figure 2. Change in FVC and FVCpp from Baseline of Bexotegrast 160 mg Over 12 Weeks


Chronic cough in IPF is often refractory and debilitating.4 It is an independent predictor of disease progression and may predict time to death or lung transplantation.5 Across all timepoints, bexotegrast-treated patients experienced reduced patient-reported cough severity as measured by the cough visual analog scale (VAS) compared to placebo patients who experienced increased cough severity at all timepoints.

 

LOGO

Figure 3. Mean Change from Baseline in Cough Severity Visual Analog Scale (VAS)

of Bexotegrast 160 mg Over 12 Weeks

Elevated integrin beta-6 plasma levels have been associated with interstitial lung disease (ILD) progression as defined by mortality, transplant or ≥ 10% relative reduction in FVC (mL) over 12 months.6 PRO-C3, a serum biomarker of type III collagen synthesis, is elevated in patients with IPF and associated with progressive disease.7 At weeks 4 and 12, bexotegrast-treated patients demonstrated a reduction in circulating biomarkers integrin beta-6 and PRO-C3 relative to placebo.

The trial’s secondary endpoint was the evaluation of the safety and tolerability of bexotegrast. Bexotegrast was well tolerated at a dose of 160 mg over 12-weeks of treatment with no serious adverse events (SAE) reported. Most frequently reported treatment-emergent adverse events (TEAEs) were mild in severity with no trial discontinuations.

“These imaging data continue to demonstrate the antifibrotic mechanism of action of bexotegrast and build on previous results, including from our INTEGRIS-IPF Phase 2a trial,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.

“Results from this first study using collagen PET imaging to assess a therapeutic intervention highlight the possible utilization of this novel technology to identify potentially disease-modifying antifibrotic IPF therapies in short-term studies,” said Sydney Montesi, M.D., Clinician-Researcher, Division of Pulmonary and Critical Care Medicine at Massachusetts General Hospital and Principal Investigator in the trial.

 

4 

van Manen MJG et al. Eur Respir Rev 2016; 25: 278–286.

5 

Ryerson CJ et al. Respirology 2011; 16: 969–975.

6 

Organ LA et al. Respir Res. 2019 Jul 12;20(1):148.

7 

Bowman WS et al. Lancet Respir Med. 2022 Jun;10(6):593-602.


A slide deck with the topline data from this trial is available under the Investors & Media section of the Pliant website at www.PliantRX.com.

Phase 2a PET Imaging Trial (NCT05621252)

This was a Phase 2a, 12-week, single-center, randomized, double-blinded, placebo-controlled trial that evaluated bexotegrast at a once-daily dose of 160mg or placebo on levels of total collagen deposition in the lungs of participants with IPF. Patients were randomized in a 2:1 ratio of (active:placebo) and stratified based on use of standard of care IPF therapy. Participants underwent positron emission tomography (PET) imaging with a radiotracer, 68Ga-CBP8, that binds to total collagen at Baseline and at Week 12. The trial’s primary endpoint was the assessment of change in Baseline of type 1 collagen in the lung and the secondary endpoint was the evaluation of the safety and tolerability of bexotegrast. The trial’s exploratory efficacy endpoints assessed changes in forced vital capacity (FVC) and forced vital capacity percent predicted (FVCpp), changes in patient reported cough severity, and changes in fibrosis biomarkers. Bexotegrast-treated patients demonstrated improvements across all the exploratory efficacy endpoints compared to placebo.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant’s lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, a Phase 2b/3 trial of bexotegrast in IPF. Pl Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody against integrin α7ß1 targeting muscular dystrophies. For additional information, please visit: www.PliantRx.com. Follow us on social media X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast, PLN-101325 and PLN-101095; bexotegrast’s potential to become a treatment for IPF and the potential future utilization of PET imaging technology to identify IPF therapies. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These


forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the impact of current macroeconomic and marketplace conditions, including the effects of health epidemics and pandemics, such as COVID-19, on our business, operations, clinical supply and plans, our reliance on third parties for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, including the availability of additional term loans under our loan facility, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the period ended December 31, 2023, as updated in our Quarterly Report on Form 10-Q for the period ended March 31, 2024, each available on the SEC’s website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:

Christopher Keenan

Vice President, Investor Relations and Corporate Communications

Pliant Therapeutics, Inc.

ir@pliantrx.com

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May 14, 2024
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Document Type 8-K
Document Period End Date May 14, 2024
Entity Registrant Name PLIANT THERAPEUTICS, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-39303
Entity Tax Identification Number 47-4272481
Entity Address, Address Line One 260 Littlefield Avenue
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code (650)
Local Phone Number 481-6770
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Security 12b Title Common Stock, par value $0.0001 per share
Trading Symbol PLRX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

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