0001564590-20-000767.txt : 20200110 0001564590-20-000767.hdr.sgml : 20200110 20200110163035 ACCESSION NUMBER: 0001564590-20-000767 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20200107 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200110 DATE AS OF CHANGE: 20200110 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Principia Biopharma Inc. CENTRAL INDEX KEY: 0001510487 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 263487603 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38653 FILM NUMBER: 20521382 BUSINESS ADDRESS: STREET 1: 400 EAST JAMIE COURT, SUITE 302 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: (650) 416-7700 MAIL ADDRESS: STREET 1: 400 EAST JAMIE COURT, SUITE 302 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 prnb-8k_20200107.htm 8-K prnb-8k_20200107.DOCX.htm

 

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): January 7, 2020

 

PRINCIPIA BIOPHARMA INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38653

26-3487603

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

220 East Grand Avenue,

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 416-7700

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 (see General Instructions A.2. below):

☐

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))

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. ☐

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

 

PRNB

 

The Nasdaq Global Select Market

 

 

 

Item 8.01 Other Events 

 

Press Releases

Principia Biopharma Inc. (the “Company”) issued a press release on January 7, 2020 announcing an expansion in the development of its lead drug candidate, PRN1008 (now known by the generic name rilzabrutinib) into IgG4-Related Disease (RD).  The Company anticipates initiating a Phase 2 clinical trial in IgG4-RD in the first half of 2020. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In addition, the Company issued a press release on January 9, 2020 announcing an expansion of its Bruton tyrosine kinase (BTK) franchise with an additional BTK inhibitor, PRN473 Topical. PRN473 Topical is entering into a Phase 1, randomized, double blind, placebo-controlled, single and multiple dose clinical trial to evaluate its safety, tolerability and pharmacokinetics.  The trial will be conducted in Australia and is expected to be completed in 2020.  

The Company also summarized certain anticipated key milestones for the Company’s clinical development programs, and announced suspension of its development of PRN1371, an FGFR inhibitor for bladder cancer, to focus the Company’s portfolio on immune-mediated diseases.  A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

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 thereunto duly authorized.

 

 

 

PRINCIPIA BIOPHARMA INC.

 

 

 

 

Date: January 10, 2020

 

By:

/s/ Roy Hardiman

 

 

 

Roy Hardiman

 

 

 

Chief Business Officer

 

 

 EX-99.1 2 prnb-ex991_6.htm EX-99.1 prnb-ex991_6.htm

Exhibit 99.1

 

Principia Announces Expanded Development Program to Broaden BTK Footprint in Immune-Mediated Diseases

 

Company’s lead candidate PRN1008 receives generic name -- rilzabrutinib

 

Rilzabrutinib to enter clinical trial in IgG4-Related Disease

 

SOUTH SAN FRANCISCO, Calif., January 7, 2020 – Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, today announced an expansion in the development of rilzabrutinib (PRN1008) into IgG4-Related Disease (RD). This clinical program broadens the company’s Bruton tyrosine kinase (BTK) therapeutic areas and supports the company’s commitment to innovate and solve high unmet needs.

“Given BTK is critical in multiple signaling pathways across a wide range of immune-mediated diseases, we are expanding our clinical focus to advance the utility of BTK inhibition. Rilzabrutinib has now demonstrated rapid onset and proof of concept in two diverse therapeutic areas, pemphigus (dermatology) and immune thrombocytopenia (hematology) and our new clinical program in IgG4-RD (rheumatology) will allow us to further demonstrate the breadth of our lead clinical candidate,” said Martin Babler, Principia’s president and chief executive officer.  

About IgG4 Related Diseases

IgG4-RD is an immune-mediated disease of chronic inflammation and fibrosis that, if left untreated, can lead to severe morbidity including organ dysfunction and organ failure, which can be fatal. IgG4-related disease typically manifests with multiple organ involvement including but not limited to exocrine glands, GI tract organs (liver, pancreas), and kidneys. Principia believes rilzabrutinib can potentially lead to positive outcomes in IgG4-RD by impacting many of the driving features of the disease, including inflammation, allergic components (IgE and eosinophils), monocytes, macrophages (involved in fibrosis), and B cells implicated in initiation and maintenance of disease.

“There is a tremendous need for new treatment options for patients with IgG4-RD. A clinical trial with rilzabrutinib is very exciting for the rheumatology community as it has the

Exhibit 99.1

potential to stop the inflammation, allergic components and fibrosis without chronic steroids or immune depleting agents. Rilzabrutinib has the potential to be a single oral agent that rapidly gets to the heart of the disease,” said John Stone, MD, MPH, professor of medicine in Boston and principal investigator.

Treatment is typically glucocorticoids (GCs), however, patients often relapse after GCs are tapered and thus require chronic GC dosing, which can lead to severe and debilitating side effects. Rituximab has been shown to have an effective clinical response; however, patients frequently relapse after treatment as well. Recent advances in the field have led to recognition of this disease and the many unmet needs for the patients diagnosed with it. Awareness and recognition of IgG4-RD is growing and the exact prevalence remains unknown, with estimates ranging from 40,000 to 180,000 in the United States alone. The company anticipates initiating a Phase 2 clinical trial in the first half of 2020.

Timely with the company’s clinical development program, the American College of Rheumatology and European League Against Rheumatism published new IgG4-RD diagnosis and treatment guidelines in the January 2020 issue of Arthritis and Rheumatology. These new treatment guidelines were led by Dr. Stone who commented: “Despite the seriousness of IgG4-RD, guidelines and treatment criteria have been non-existent. Validated in 1,879 subjects, these criteria should contribute substantially to future clinical, epidemiologic, and basic investigations.”  

About Rilzabrutinib  

Rilzabrutinib, Principia’s most advanced drug candidate, is an oral, first-in-class, reversible covalent, BTK inhibitor optimized for the treatment of immune-mediated diseases. Bruton tyrosine kinase (BTK) is involved in innate and adaptive immune responses and is a critical signaling molecule in immune-mediated diseases. Rilzabrutinib data demonstrates an ability to block inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib’s unique attributes are based in the power of the bond from Principia’s proprietary Tailored Covalency® platform.  This enabled the company to optimize rilzabrutinib’s safety and efficacy profile, with prolonged and reversible action at the target site while being rapidly eliminated from the body. Principia believes this bonding and the limited systemic exposure of rilzabrutinib enables rapid clinical reversibility of effects on the immune system, and it is thus designed for safety in immune-mediated diseases.  

Exhibit 99.1

About Principia Biopharma

Principia is a late-stage biopharmaceutical company dedicated to bringing transformative therapies to patients with significant unmet medical needs in immune-mediated diseases. Principia’s proprietary Tailored Covalency® platform differentiates the company’s investigational therapies from traditional small molecules and provides the potential to deliver the potency, selectivity and safety of injectable drugs while maintaining the convenience of a pill. This highly reproducible approach enables the company to pursue multiple programs efficiently. Rilzabrutinib, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus -- an orphan autoimmune disease – and a Phase 2 clinical trial in patients with immune thrombocytopenia (ITP), and the company plans to initiate a Phase 2 clinical trial in patients with IgG4-related diseases. PRN2246/SAR442168, a covalent BTK inhibitor which crosses the blood-brain barrier, is being evaluated in a Phase 2 clinical trial in patients with multiple sclerosis and is partnered with Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer. For more information, please visit www.principiabio.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Principia’s expectations regarding the Principia pipeline of product candidates, the design of, progress of, results from, and timing of, its clinical trials and information regarding the timing, scope and success of additional clinical results. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principia’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Principia’s business in general, see the risk factors set forth in Principia’s reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Principia specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact
Christopher Chai, CFO
ir@principiabio.com

Media Contact
Paul Laland, VP of Corporate Communications
paul.laland@principiabio.com
415.519.6610

 

 

 EX-99.2 3 prnb-ex992_7.htm EX-99.2 prnb-ex992_7.htm

 

 

Exhibit 99.2

 

 

Principia Announces Expansion of its BTK Franchise with PRN473 Topical

 

Company expands focus on immune-mediated diseases and

suspends FGFR program

Company outlines anticipated key corporate milestones

 

SOUTH SAN FRANCISCO, Calif., January 9, 2020 – Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, today announced an expansion of its Bruton tyrosine kinase (BTK) franchise with PRN473 Topical. The company also announced suspension of PRN1371, an FGFR inhibitor for bladder cancer to focus the portfolio on immune-mediated diseases.

“PRN473 Topical broadens Principia’s portfolio of purpose-designed BTK inhibitors, with the goal of expanding the options for patients and the knowledge of BTK’s role across immune-mediated diseases,” said Martin Babler, Principia’s president and chief executive officer. “Principia remains at the forefront of BTK immune therapy with three separate molecules and approaches (systemic, topical, and CNS), each with distinctive rationales and potential future commercial opportunities.”

By commencing clinical development of PRN473 Topical, a reversible covalent BTK inhibitor, Principia believes topical administration will be an important addition to the expected utility of systemic BTK inhibition (rilzabrutinib) and CNS-penetrant BTK therapy (SAR442168/PRN2246).  Each of the three programs were discovered by Principia and have separate intellectual property estates.

About PRN473 Topical

PRN473 Topical, an investigational drug, is entering into a Phase 1, randomized, double blind, placebo-controlled, single and multiple dose trial to evaluate its safety, tolerability and pharmacokinetics. The trial will be conducted in Australia and is expected to be completed in 2020.

BTK is involved in innate and adaptive immune responses and is a critical signaling molecule in immune-mediated diseases. BTK inhibitors have demonstrated an ability to block

 

 

 

 

 

 

Exhibit 99.2

 

inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Given the abundance of immune cells in skin and their role in immune-mediated diseases, PRN473 Topical is being developed for localized skin applications. PRN473 Topical is the company’s third BTK inhibition molecule to enter the clinic, joining rilzabrutinib, an oral, reversible covalent BTK inhibitor designed to treat systemic diseases (pemphigus, immune thrombocytopenia, and IgG4-RD) and SAR442168/PRN2246, the company’s partnered central nervous system (CNS) penetrating BTK inhibitor that targets immune and inflammatory diseases of the CNS (multiple sclerosis).

Anticipated key corporate milestones

Principia also announced anticipated key milestones for the company’s clinical development programs:

 

-

Rilzabrutinib

 

o

1H20 – Presentation of pemphigus Phase 2 Part B trial

 

o

1H20 – Initiation of Phase 2 trial for IgG4-RD

 

o

2H20 – Presentation of ITP Phase 2 trial

 

o

2H21 – PEGASUS Phase 3 trial results (accelerated from 1H22)

 

-

PRN473 Topical

 

o

1H20 – Initiation of Phase 1 trial

 

o

2020 – Phase 1 trial results

 

-

SAR442168 / PRN2246

 

o

1Q20 – Sanofi anticipates Phase 2b trial data in multiple sclerosis

 

o

2020 – Principia Phase 3 co-funding decision

About Principia Biopharma

Principia is a late-stage biopharmaceutical company dedicated to bringing transformative therapies to patients with significant unmet medical needs in immune-mediated diseases. Principia’s proprietary Tailored Covalency® platform differentiates the company’s investigational therapies from traditional small molecules and provides the potential to deliver the potency, selectivity and safety of injectable drugs while maintaining the convenience of a pill or cream. This highly reproducible approach enables the company to pursue multiple programs efficiently. Rilzabrutinib, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus -- an orphan autoimmune disease -- a Phase 2 clinical trial in patients

 

 

 

 

with immune thrombocytopenia (ITP), and the company plans to initiate a Phase 2 clinical trial in patients with IgG4-related diseases. PRN2246/SAR442168, a covalent BTK inhibitor which crosses the blood-brain barrier, is being evaluated in a Phase 2 clinical trial in patients with multiple sclerosis and is partnered with Sanofi. PRN473 Topical, a reversible covalent BTK inhibitor plans to initiate a Phase 1 clinical trial for immune-mediated diseases. For more information, please visit www.principiabio.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Principia’s expectations regarding the Principia pipeline of product candidates, the design, progress, initiation, and timing of, and results from, its clinical trials and information regarding the timing, scope and success of clinical results and potential commercial opportunities. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principia’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Principia’s business in general, see the risk factors set forth in Principia’s reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Principia specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact
Christopher Chai, CFO
ir@principiabio.com

Media Contact
Paul Laland, VP of Corporate Communications
paul.laland@principiabio.com

415.519.6610

 

 

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