Processa Pharmaceuticals to Present PCS12852 Gastroparesis Results at the Digestive Disease Week 2023 Annual Meeting
28 Aprile 2023 - 2:15PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the
“Company”), a clinical-stage pharmaceutical company now focused on
developing the next generation of chemotherapeutic drugs to improve
the efficacy and safety for patients suffering from cancer, today
announces it will be presenting data on the use of PCS12852 to
treat gastroparesis patients at the annual Digestive Disease Week
(DDW) conference held in Chicago’s McCormick Place from May 6-9,
2023. PCS12852 is a Phase 2b-ready, very potent and very selective
novel 5-HT4 agonist, for which the company is exploring
partnerships and other options to advance the program.
The study, titled “PCS12852, A Novel 5-HT4
Agonist Improves GCSI Symptom Scores and Gastric Emptying in
Gastroparesis Patients,” will be presented during the May 6th
Research Forum Session, AGA Gastroparesis and Small Intestinal
Dysmotility held from 2-3:30 PM CT. Sian Bigora, Pharm.D., Processa
Pharmaceuticals’ Chief Development and Regulatory Officer, will
present the Phase 2a results on the improvement in symptom scores
and gastric emptying rate in gastroparesis patients treated with
PCS12852.
David Young, Pharm.D., Ph.D., Processa’s
President and CEO, commented, “We continue to see encouraging
results with our drug development pipeline, and inclusion in the
DDW conference as an oral presentation is important and continued
validation for our Regulatory Science approach. Since the
FDA-approved gastroparesis drugs have severe safety limitations,
the fact that PCS12852 is ready to move to a Phase 2b trial given
the positive safety and efficacy results in our proof-of-concept
gastroparesis trial is a significant milestone. The Company is
diligently exploring strategies to advance or monetize the program.
We look forward to a robust discussion of the data throughout the
DDW conference, and to providing continued updates to our
shareholders.”
About Processa Pharmaceuticals,
Inc.
Processa is a clinical stage pharmaceutical
company focused on developing the Next Generation Chemotherapy
(NGC) drugs to improve the safety and efficacy of cancer treatment.
By combining Processa’s novel oncology pipeline with proven
cancer-killing active molecules and the Processa Regulatory Science
Approach as well as experience in defining Optimal Dosage Regimens
for FDA approvals, Processa not only will be providing better
therapy options to cancer patients but also increase the
probability of FDA approval for its Next Generation Chemotherapy
(NGC) drugs following an efficient path to approval. Processa’s NGC
drugs are modifications of existing FDA-approved oncology drugs
resulting in an alteration of the metabolism and/or distribution of
these FDA-approved drugs while maintaining the existing mechanisms
of killing the cancer cells. The company’s approach to drug
development is based on more than 30 years of drug development
expertise to efficiently design and conduct clinical trials that
demonstrate a positive benefit/risk relationship. The Processa team
has a track record of obtaining over 30 approvals for indications
across almost every division of FDA. Using its proven Regulatory
Science Approach, the Processa Team has experience defining the
Optimal Dosage Regimen using the principles of the FDA’s Project
Optimus Oncology initiative. The advantages of
Processa’s NGCs are expected to include fewer
patients experiencing side effects that lead to dose
discontinuation, more significant cancer response and a greater
number of patients -- in excess of 200,000 for each NGC drug -- who
will benefit from each NGC drug. Currently under development are
three next generation chemotherapy oncology treatments: Next
Generation Capecitabine (PCS6422 and capecitabine to treat
metastatic colorectal, gastrointestinal, breast, pancreatic, and
other cancers), Next Generation Gemcitabine (PCS3117 to treat
pancreatic, lung, ovarian, breast, and other cancers), and Next
Generation Irinotecan (PCS11T to treat lung, colorectal,
gastrointestinal, pancreatic, and other cancers).
For more information, visit our website at
www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking
statements. The statements in this press release that are not
purely historical are forward-looking statements which involve
risks and uncertainties. Actual future performance outcomes and
results may differ materially from those expressed in
forward-looking statements. Please refer to the documents filed by
Processa Pharmaceuticals with the SEC, specifically the most recent
reports on Forms 10-K and 10-Q, which identify important risk
factors which could cause actual results to differ from those
contained in the forward-looking statements.
For More
Information:Investors:Bret ShapiroCORE
IRir@processapharma.com
Company Contact:Patrick Lin(925)
683-3218plin@processapharma.com
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