Press Release Details

Patient data establishes key correlations for therapeutic exposure in tissue and alternative inflammatory pathways, supporting the hypotheses of targeted therapeutic delivery and potential combination therapy for ulcerative colitis

SAN DIEGO, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), a biotechnology company innovating in the field of oral biotherapeutics for gastrointestinal health and beyond, today shared two poster presentations that were presented during the 17^th Congress of the European Crohn’s and Colitis Organisation (ECCO) on February 18, 2022.

Dr. Geert D'Haens and Mr. Joep van Oostrom shared a poster titled “Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe UC,” which explores potential causes for the 30% of patients who are primary non-responders to anti-TNF therapies. The pro-inflammatory cytokine interleukin 6 (IL6) was observed at high levels in tissue, suggesting it may be a driver of inflammation alternative to TNF in ulcerative colitis. This suggests a need for combination therapy.

Dr. Bram Verstockt and Dr. Séverine Vermeire presented a poster titled “Tofacitinib tissue exposure correlates with endoscopic outcome,” which highlighted a significant relationship between mucosal exposure and endoscopic improvement in tofacitinib-treated patients with moderate to severe ulcerative colitis (UC).

“Many ulcerative colitis patients go through several rounds of treatment with various drugs and see no improvement. These are people who are suffering,” said Adi Mohanty, Chief Executive Officer of Progenity. “By establishing data on the amount of mucosal exposure needed to achieve clinical outcomes, and also achieving a better understanding of the multiple inflammatory pathways that contribute toward the pathophysiology of ulcerative colitis, the independent research presented by our collaborators at ECCO helps to establish the foundation for two areas of opportunity to improve outcomes for patients with UC,” said Mr. Mohanty.

Mr. Mohanty continued, “Our targeted therapeutics platform is designed to achieve higher doses in tissue while avoiding current issues with toxicity due to systemic uptake. Reduced systemic uptake could open the door for combination therapy to simultaneously target multiple inflammatory pathways. We believe that our technology will open new opportunities for novel therapeutic combinations for patients who today are unable to achieve remission of symptoms. We thank our clinical collaborators as we all work toward better therapeutic outcomes for patients.”

Both ECCO posters are now available by visiting the “Publications” section of the Progenity website.

About the Drug Delivery System (DDS) and PGN-600
Progenity’s Drug Delivery System (DDS) is an ingestible capsule designed for targeted delivery of therapeutics to improve treatment of inflammatory bowel disease (IBD). Of the 1.8 million patients in the United States who suffer from IBD, a majority do not achieve sustained remission with existing therapeutics, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues.

The DDS targeted therapeutics platform utilizes a novel approach that could improve IBD patient outcomes by maximizing the available dose at the site of disease while reducing systemic toxicity. Once swallowed, the capsule is designed to autonomously identify when it has arrived at a specific location in the gastrointestinal tract and release a therapeutic dose at the site of disease. The DDS is approximately the size of a “000” capsule, the size of many fish oil capsules. It is designed to deliver a range of liquid formulations in amounts up to 500 µL. In normal healthy volunteers, the DDS capsule was shown to be safe and accurate in identifying entry into the colon. Progenity is a recipient of the Crohn’s and Colitis Foundation IBD Ventures development grant to support development and further clinical evaluation of the DDS platform.

Progenity is developing the PGN-600 program, which consists of oral liquid formulation of tofacitinib delivered to the colon via the DDS capsule, for the treatment of ulcerative colitis. The company has shown in animal models that successful targeted delivery using PGN-600 can lead to significantly reduced drug levels in blood and increased drug levels in tissue at least 25 times higher along the length of the colon as compared to the equivalent standard oral dose. Progenity expects to initiate a phase 1 clinical trial of PGN-600 in late 2022.

About Progenity
Progenity, Inc. is a biotechnology company innovating in the fields of oral biotherapeutics, gastrointestinal health, and women’s health. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity’s vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

Forward Looking Statements
This press release contains “forward-looking statements,” which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Forward-looking statements include statements regarding Progenity’s products under development and the potential uses for such products in the United States and globally. In some cases, you can identify forward-looking statements by terms such as “if,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity’s actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity’s ability to successfully develop and commercialize its products under development, the uncertainties inherent in the development process, such as the regulatory approval process, the timing of regulatory filings, the ability to identify potential partners and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity’s products, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Progenity’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity’s Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
ir@progenity.com
(917) 741-7792

Media Contact
Kristin Schaeffer
CG Life
media@progenity.com
(858) 457-2436