Processa Pharmaceuticals said it has acquired Vidya Therapeutics in a stock-for-stock transaction and entered into a concurrent private placement financing expected to generate approximately $200 million in gross proceeds. The company said the financing is expected to fund operations into the second half of 2029 and support multiple clinical milestones.
George Ng, CEO of Processa Pharmaceuticals, said Vidya founder Sheila Gujrathi has joined Processa’s board of directors in connection with the transaction. Gujrathi will lead the presentation of Vidya’s lead program, VT-7208, an oral Bruton’s tyrosine kinase, or BTK, inhibitor being developed for immune-mediated and central nervous system diseases.
Three Phase 2 Programs Planned
Gujrathi said VT-7208 is designed as a potentially best-in-class, once-daily BTK inhibitor intended to improve upon the efficacy, safety and convenience of earlier-generation programs. The company plans to advance the asset into Phase 2 proof-of-concept studies in food allergy, chronic spontaneous urticaria, or CSU, and relapsing multiple sclerosis, or RMS.
The food allergy and CSU trials are expected to begin in the second half of 2026. Processa expects food-allergy data in the second half of 2027 and CSU data in the first half of 2028. The RMS study is expected to begin in the first half of 2027, with data anticipated in the second half of 2028.
“This transaction gives us the capital to evaluate VT-7208’s potential across multiple indications in parallel rather than sequentially,” Gujrathi said. She described food allergy and CSU as faster and more capital-efficient proof-of-concept studies, while the multiple sclerosis program offers longer-term opportunity in neuroinflammatory disease.
According to Gujrathi, more than 1.7 million patients in the United States with CSU remain uncontrolled on antihistamines, while roughly 14 million people with food allergies continue to manage the condition through avoidance or emergency rescue. She also said multiple sclerosis patients continue to experience disability and disease progression despite existing treatment options.
Phase 1 Findings
Vidya completed the primary safety and dose-escalation portions of a Phase 1 study of VT-7208. The study included single ascending doses ranging from 5 milligrams to 60 milligrams and multiple ascending doses administered once daily for seven days.
Gujrathi said VT-7208 was generally well tolerated across all evaluated doses, including up to 60 milligrams daily. There were no serious adverse events and no study discontinuations. The only Grade 3 event was arm pain related to repeated blood draws and was not attributed to the drug, while two mild headaches resolved on their own, she said.
The company reported no liver or bleeding safety signals, which Gujrathi identified as adverse events of special interest for the BTK inhibitor class. Phase 1 results also showed dose-proportional exposure, an approximately six-hour half-life and no accumulation after repeated dosing, according to the presentation.
- Near-complete BTK receptor occupancy was observed for 24 hours after single doses from 5 milligrams to 60 milligrams.
- At the 5-milligram dose, receptor occupancy remained above 95% at 48 hours and was approximately 90% at 72 hours, according to Gujrathi.
- Multiple-dose cohorts showed near-complete target occupancy at steady state and complete inhibition of phospho-BTK, a measure of pathway signaling.
- The study also included cerebrospinal fluid sampling, which the company said confirmed central nervous system exposure.
Gujrathi said the data support a low-dose, once-daily oral treatment profile and could enable development in both peripheral immune diseases and central nervous system conditions. Processa plans to provide updates as VT-7208 advances through its Phase 2 programs.
About Heatwurx (NASDAQ:PCSA)
Processa Pharmaceuticals, Inc, a clinical stage biopharmaceutical company, develops chemotherapy drugs to improve the safety and efficacy of cancer treatment. Its drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of drugs while maintaining the existing mechanisms of killing the cancer cells. The company's pipeline includes three chemotherapy drugs comprising Gemcitabine, PCS3117 that has completed Phase 2a clinical trials to treat pancreatic, biliary tract, lung, ovarian, breast, and other cancers; Capecitabine, a combination of PCS6422 and capecitabine that has completed Phase 1b clinical trials to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers; and Irinotecan, PCS11T that is in pre-clinical studies to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers.
