PR600 / Dr Falk, Merck (MSD) - LARVOL DELTA

A Study of PRA052 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Completed | Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active, not recruiting ➔ Completed

Trial completion

A Study of PRA052 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Prometheus Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Prometheus Biosciences Reports First Quarter 2023 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "Research and Development (R&D) Expenses. Research and development expenses were $36.4 million for the three months ended March 31, 2023 compared to $27.9 million for the three months ended March 31, 2022. The increase is primarily due to preparation for the global Phase 3 clinical trials for PRA023 as well as the ongoing Phase 2 clinical trial for the SSc-ILD indication and the Phase 1 clinical trial of PRA052."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Interstitial Lung Disease • Scleroderma • Systemic Sclerosis • Ulcerative Colitis

A Study of PRA052 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Prometheus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of PRA052 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=104 | Not yet recruiting | Sponsor: Prometheus Biosciences, Inc.

New P1 trial

"$RXDX Prometheus Biosciences Receives FDA Clearance of IND Application for its Second Precision Program, PRA052 https://t.co/Mk2p0dsbJw" (@stock_titan)

FDA event

Prometheus Biosciences Receives FDA Clearance of IND Application for its Second Precision Program, PRA052 (GlobeNewswire) - "Prometheus Biosciences, Inc...announced the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a clinical trial under its Investigational New Drug Application (IND) for PRA052 in ulcerative colitis. Initiation of a Phase 1 SAD/MAD study for PRA052 in normal healthy volunteers is expected to commence in the fourth quarter of this year."

IND • New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Prometheus Biosciences Reports Second Quarter 2022 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "Research and Development (R&D) Expenses. Research and development expenses were $25.9 million for the three months ended June 30, 2022 compared to $13.6 million for the three months ended June 30, 2021 primarily due to advancement of PRA023 in global Phase 2 clinical trials and PRA052 toward IND."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Systemic Sclerosis • Ulcerative Colitis

PROMETHEUS BIOSCIENCES, INC. : Other Events (form 8-K) (Market Screener) - "Prometheus Biosciences, Inc...announced R&D Day focused on the Company's second program, PR600, and unveiled its corresponding clinical candidate, PRA052, an anti-CD30L monoclonal antibody. The CD30L-CD30 co-stimulatory pathway has been implicated in inflammatory bowel disease ('IBD') by genetic, preclinical, and human translational data....The Company plans to file an investigational new drug application ('IND') for PRA052 in the third quarter of 2022 and expects to advance PRA052 into a Phase 1 single ascending dose/multiple ascending dose clinical trial in normal healthy volunteers in the fourth quarter of 2022."

IND • New P1 trial • Preclinical • Immunology • Inflammatory Bowel Disease

R&D Day PR600 Target Unveiling (Prometheus) - "Unmet Need and Implication of Precision Approach in IBD."

Live event

Prometheus Biosciences to Host a Virtual R&D Day for Analysts and Investors on July 26, 2022 (GlobeNewswire) - "Prometheus Biosciences, Inc...announced it will host a virtual R&D Day for analysts and investors at 9:00 am ET on Tuesday, July 26, 2022. The presentations will showcase Prometheus’ second program, PR600 and its corresponding clinical candidate, PRA052, reveal the therapeutic target and provide detailed scientific rationale on the approach. In addition to presentations by Prometheus’ senior management team, the R&D Day will feature key opinion leader, Marla Dubinsky, MD, Chief of the Division of Pediatric Gastroenterology and Director of the Inflammatory Bowel Disease Center at Mount Sinai Health System."

Clinical • Immunology • Inflammatory Bowel Disease

Prometheus Biosciences Reports First Quarter 2022 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "Research and Development (R&D) Expenses. Research and development expenses were $27.9 million for the three months ended March 31, 2022 compared to $7.8 million for the three months ended March 31, 2021 primarily due to advancement of PRA023 through global Phase 2 clinical trials and PR600 toward IND."

Commercial • Immunology • Inflammatory Bowel Disease • Interstitial Lung Disease • Systemic Sclerosis

Prometheus Biosciences Reports Fourth Quarter and Full-Year 2021 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "Prometheus’ Phase 2 ARTEMIS-UC clinical trial is currently enrolling patients with moderate-to-severely active UC who have failed conventional therapy, including biologics....IND submission for PR600 planned for 3Q...Topline results are expected in 4Q 2022....Prometheus’ Phase 2a APOLLO-CD clinical trial is a 12-week open-label study that is currently enrolling patients with moderate-to-severely active CD...Topline results expected in 4Q 2022...Research and Development (R&D) Expenses. Research and development expenses were $23.6 million for the three months ended December 31, 2021...The increases were primarily driven by advancement of PRA023 into global Phase 2 clinical trials, as well as advancing our other development programs."

Commercial • Enrollment status • IND • P2 data • P2a data • Crohn's disease • Inflammatory Bowel Disease • Systemic Sclerosis • Ulcerative Colitis

Prometheus Biosciences and Dr. Falk Pharma Advance PR600 and Trigger Final Preclinical Milestone Payment (GlobeNewswire) - "Prometheus Biosciences, Inc...announced it has received its final preclinical milestone payment from Dr. Falk Pharma GmbH under its collaboration agreement to develop and commercialize Prometheus’ second program, PR600. The milestone was based on Prometheus’ development of a proprietary companion diagnostic candidate for the PR600 program...'We are excited to initiate this program with our proprietary companion diagnostic candidate in the clinic in 2022 and explore its utility in IBD and potentially other immune-mediated indications'...Prometheus expects to submit an Investigational New Drug Application for PR600 in the third quarter of 2022."

Commercial • IND • New trial • Immunology • Inflammatory Bowel Disease

"$RXDX Prometheus Biosciences and Dr. Falk Pharma Advance PR600 and Trigger Final Preclinical Milestone Payment https://t.co/RZOEEqjAuA" (@stock_titan)

Preclinical

Prometheus Biosciences Reports Second Quarter 2021 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "Upcoming Milestones and Events:...IND to be filed for PR600 in 3Q 2022. Topline results from the ARTEMIS-UC Phase 2 study expected in 4Q 2022. Topline results from APOLLO-CD Phase 2a study expected in 4Q 2022....Research and development expenses were $13.6 million for the second quarter ended June 30, 2021, compared to $4.9 million for the second quarter ended June 30, 2020, and $21.3 million for the first half of 2021 compared to $9.2 million for the first half of 2020. The increases were primarily driven by advancement of PRA023 into the clinical stage of development..."

Commercial • IND • P2 data • P2a data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Prometheus Biosciences Achieves Milestone Payment from Dr. Falk Pharma GmbH Further Validating the Prometheus360 Platform (GlobeNewswire) - "Prometheus Biosciences, Inc...announced it has received a $10 million milestone payment from Dr. Falk Pharma GmbH under its collaboration agreement to develop and commercialize Prometheus’ second program, PR600. Prometheus has selected a clinical candidate for PR600, targeting an undisclosed member of the tumor-necrosis factor superfamily for the treatment of IBD and is initiating IND-enabling studies...'We expect to file an Investigational New Drug Application for PR600 in the third quarter of 2022 and plan to explore its utility in other immune-mediated indications beyond IBD.'"

Commercial • IND • Inflammatory Bowel Disease