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Protagonist Therapeutics Presents Clinical Data from the PROPEL Study of PTG-100 in Ulcerative Colitis at United European Gastroenterology Week
-- PTG-100 demonstrates signals of clinical efficacy and is well tolerated --
-- Dose-dependent induction of histologic remission provides further support for PTG-100 as an oral, gut-restricted approach for alpha-4-beta-7-integrin-targeted therapy --

NEWARK, Calif., Oct. 22, 2018 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today presented clinical data from the PROPEL study of PTG-100, the Company's oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide for the treatment of ulcerative colitis (UC), in a featured oral presentation at the United European Gastroenterology Week (UEGW). Data from the PROPEL study demonstrated that treatment with PTG-100 was associated with higher rates of clinical remission relative to placebo. In addition, a dose-dependent increase in rates of histologic remission and target engagement based on blood biomarker of receptor occupancy was also observed in the study. No safety concerns were noted in the study.

The histologic and blood biomarker data and topline safety data presented at the meeting expand upon the clinical remission and endoscopic response results announced previously in August 2018 that involved an independent, blinded re-read of endoscopies and had demonstrated signals of clinical efficacy. A human error in initial endoscopy reads by the original vendor which was characterized by an unusually high placebo effect (4/17, 23.5%) had led to the original futile outcome reported in March 2018. A presentation abstract of the UEGW presentation will be available at https://www.ueg.eu and published in the December issue of European Gastroenterology Journal. A summary of clinical data follows.

Treatment arm (N=83)

Clinical remission

Endoscopic response*

Histologic remission

PTG-100 (150 mg QD)

2/22 (9.1%)

2/22 (9.1%)

2/13 (15%)

PTG-100 (300 mg QD)

2/21 (9.5%)

3/21 (14.3%)

2/9 (22%)

PTG-100 (900 mg QD)

3/19 (15.8%)

3/19 (15.8%)

7/16 (44%)

Placebo

1/21 (4.8%)

1/21 (4.8%)

0/13 (0%)

*defined as an endoscopic subscore of 0 or 1

†Robarts Histopathology Index score of less than or equal to 3

"PTG-100 is safe and well tolerated, and the totality of the data which now include clinical, endoscopic, histologic and biomarker data is consistent with both a biologic and clinical dose-dependent response for this oral peptide agent," commented William J. Sandborn, M.D., Chief of the Division of Gastroenterology and Professor of Medicine at the University of California San Diego School of Medicine. "It is highly encouraging to see these results that support further development of PTG-100 as there is a clear need for oral targeted therapy agents working through proven and safe mechanisms such as the alpha-4-beta-7-integrin pathway."

"The results presented today provide the first demonstration of signals of clinical efficacy with an oral alpha-4-beta-7-integrin specific antagonist," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "Despite a small sample size (n=83 patients), it is encouraging to see that the observed clinical remission rates for PTG-100 are on par with other oral and injectable drugs approved or in development for treatment of UC. We are very encouraged by these findings and look forward to progressing PTG-100 further in clinical development in UC pending our discussions with U.S. and European regulatory agencies. Overall, we also view this cumulative data as supportive of the broader GI-restricted, oral targeted therapy approach enabled by our proprietary technology platform for the treatment of inflammatory bowel diseases."

About the Phase 2b PROPEL Trial

The Phase 2b PROPEL trial was a global, randomized, double-blind, placebo-controlled, two-stage adaptive clinical trial to assess the safety, efficacy, and dose-optimization of three doses (150 mg, 300 mg, or 900 mg) of PTG-100 compared to placebo for 12 weeks in patients with moderate to severe ulcerative colitis. The primary efficacy endpoint of the study was the proportion of patients who achieved clinical remission as defined by rectal bleeding, stool frequency, and endoscopic subscores of the Mayo score, as per most recent FDA guidance.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. PTG-100 is an oral alpha-4-beta-7 integrin specific antagonist peptide that is under development for potential treatment of inflammatory bowel diseases. PTG-200 is an oral peptide interleukin-23 receptor antagonist in development for the treatment of Crohn's disease. The company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200. Protagonist is also developing an injectable hepcidin mimetic, PTG-300, for the potential treatment of anemia and iron overload related to rare blood diseases with an initial focus on beta-thalassemia. The company has completed a Phase 1 clinical trial of PTG-300, which established safety/tolerability and pharmacodynamic-based clinical proof-of-concept in normal healthy volunteers. The U.S. Food and Drug Administration has granted Orphan Drug designation and Fast Track designation to PTG-300 for beta-thalassemia for which a global Phase 2 trial is to be initiated in the fourth quarter of 2018.

Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our programs including PTG-100 and the initiation and availability of results of our clinical trials. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our quarterly report on Form 10-Q for the three months ended June 30, 2018 filed with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

 

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SOURCE Protagonist Therapeutics, Inc.

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