PCSA) administers first dose in modified Phase 1B study

Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life of patients with unmet medical needs, has entered its modified maximum tolerated dose Phase 1B ( “DMT”) trial for next-generation capecitabine, or the combination of PCS6422 and capecitabine. The company announced that the first patient, who was diagnosed with advanced and refractory gastrointestinal cancer, received a dose. Previously, Processa reported that a single dose of its proprietary PSC6422 successfully inhibited dihydropyrimidine dehydrogenase (“DPD”), resulting in capecitabine that was approximately 50 times more potent than FDA-approved capecitabine; however, the improved potency did not last through the seven days of capecitabine administration. According to the announcement, the modified protocol provides a more accurate timeline of DPD inhibition and de novo formation while providing essential critical data on the efficacy of a personalized medicine approach for next-generation capecitabine. . “Our goal with next-generation capecitabine is to provide more effective and/or safer therapy for patients with gastrointestinal cancer and other types of cancer,” said Processa President and CEO Dr. David Young, in the press release. “Revisions to the original protocol will now provide the data, which will not only allow us to significantly increase the potency of next-generation capecitabine throughout capecitabine dosing, but could also lead to more optimal dosing for each patient. thanks to an individualized and personalized medical approach. We expect to have preliminary data on an improved next-generation capecitabine regimen by mid-2022 and expect the BAT for next-generation capecitabine to be determined by the end of 2022. We then plan to move to a phase 2B or phase 3 trial in 2023 based on our discussions with the FDA.

To view the full press release, visit https://ibn.fm/WHqpE

About Processa Pharmaceuticals Inc.

Processa’s mission is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses these selection criteria to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include PCS6422 (“PCS6422”), a metastatic colorectal cancer and breast cancer program; PCS499 (“PCS499”), an ulcerative necrobiosis lipoidia program; and PCS12852 (“PCS12852”), gastrointestinal motility/gastroparesis program. Members of Processa’s development team have participated in more than 30 FDA drug approvals, including drug products targeted at orphan diseases, and more than 100 FDA meetings throughout their careers. For more information, visit the Company’s website at www.ProcessaPharma.com.

NOTICE TO INVESTORS: The latest PCSA news and updates can be found in the company’s newsroom at https://ibn.fm/PCSA

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