The pivotal role of the human gut microbiome in health and disease has garnered widespread recognition. This has shed light on the intricate bidirectional communication between the gut microbiome and various organs via the "Gut-Organ axis." Dysregulation in this complex communication network, orchestrated by diverse inflammatory signaling pathways, significantly contributes to the onset and progression of chronic conditions.
Studies have shown that chronic inflammatory diseases such as inflammatory bowel disease and rheumatoid arthritis are linked to insulin resistance, dyslipidemia, hypertension, and an increased risk of developing conditions like metabolic syndrome, type 2 diabetes, cardiovascular disease susceptibility to infections, and neurocognitive disorders. Effective medications like Etanercept and Canakinumab have demonstrated the ability to decrease insulin resistance, improve insulin sensitivity, and reduce the risk of Alzheimer’s and cardiovascular diseases. Furthermore, research on oral gut-specific enzyme supplementation that targets inflammation has yielded promising outcomes, including an extended lifespan and decreased frailty in mouse model studies. Thus, research efforts aimed at elucidating the mechanisms through which gut dysbiosis contributes to the pathogenesis of chronic diseases, particularly emphasizing the significance of inflammatory pathways, are poised to catalyze the development of innovative therapeutic interventions.
Vidisha Mohad's journey into understanding the crucial role of the gut-organ axis began during her scientific exploration of the gut microbiome's impact on chronic diseases. During her tenure as a postdoctoral fellow in Dr. Richard Hodin's laboratory at Harvard Medical School and MGH, Vidisha immersed herself in understanding the gut epithelial biology, microbiome dynamics, and mechanisms of inflammatory diseases. Her objective was to understand and uncover new targets and pathways capable of mitigating inflammation, a fundamental driver of chronic illnesses. During this time, she worked on a technology demonstrating compelling biological evidence against inflammation and efficacy in many disease models. This technology, now known as RSY-248, specifically targets the LPS/TLR4/NFkB pathway, a crucial component of the gut-organ axis and significantly relevant in patients with ulcerative colitis. At the time, another biotech was already in the clinical stage of developing RSY-248, and she eagerly anticipated its release to benefit patients and enhance their quality of life. However, to her surprise, she later learned that the development of the drug was being halted.
Vidisha recognized a unique opportunity here to leverage her extensive expertise in gut inflammation biology to resurrect RSY-248. RSY-248 was being developed for cancer treatment but was shelved and deprioritized due to strategic decisions that had nothing to do with its efficacy. Inspired by successful entrepreneurs like Vivek Ramaswamy of Roivant and Neil Kumar of BridgeBio, Vidisha envisioned building a diversified company centered on the gut-organ axis. She asked herself, “Do I really need to reinvent the wheel to develop this promising drug?” Fueled by passion, determination, and grit, Vidisha successfully secured the licensing rights for RSY-248.
With this accomplishment, Rasayana Therapeutics was born, marking the beginning of Vidisha's entrepreneurial journey. She envisioned Rasayana as a pioneering "Hub and Spoke" enterprise built upon two foundational principles: leveraging the capabilities of the gut-organ axis and advancing gut-targeted assets that have already demonstrated safety and de-risked. RSY-248 serves as just the inaugural chapter in Rasayana's future "Hub and Spoke" narrative, heralding a revolutionary impact on chronic disease treatment. Rasayana (pronounced ruh-sa-yuh-na), derived from Ayurveda, embodies the essence of "improving immunity, extending longevity, and enhancing overall well-being." Vidisha's resolute mission is clear: to significantly improve the lives of patients suffering from chronic illnesses through the rapid development of innovative and safe gut-targeted drugs.
Rasayana is laser-focused on advancing the lead program, RSY-248, a first-in-class oral, gut-restricted biologic targeting the LPS/TLR4 and intestinal barrier function. RSY-248 has shown robust preclinical efficacy and achieved exceptional safety and tolerability outcomes in Phase 1 clinical trials. Buoyed by these compelling Phase 1 results, Rasayana is diligently preparing for Phase 2 readiness. Once RSY-248 achieves a significant value inflection point, they aim to expand their asset and patient-centered internal target discovery engine to broaden the Gut-Organ axis pipeline.
Rasayana’s progress thus far has been fueled by pre-seed investments, and they are now embarking on a pivotal phase with concurrent fundraising efforts for a $5 million Seed round and a $40 million Series A round. The seed capital will support toxicology studies, finalize manufacturing/CMC prerequisites, gut-restricted assay validation, Ph2 protocol drafts, and engage in FDA Type B meetings. These efforts are crucial for our Phase 2 readiness submission to the FDA by Q4 2024, aiming to dose our first patient by Q2 2025
Vidisha has assembled a world-class team of scientific advisors, pharmaceutical-experienced drug developers, and board members with unparalleled expertise. This collective intellectual capital is poised to revolutionize chronic disease treatment by targeting the Gut-Organ axis. Rasayana invites you to join them on this transformative journey. Visit www.rasayanatherapeutics.com to learn more about Rasayana and how you can contribute to their groundbreaking mission.