Gravitas Life Sciences
Lead Clinical Program
Developing Products to Serve Unmet Needs
GV104 represents a novel advancement in pharmaceutical innovation, serving as a cornerstone for our lead clinical program. This product is meticulously crafted by embedding a drug onto a proprietary transmucosal buccal film, designed to adhere seamlessly to the inner lining of the mouth. This unique formulation of GV104 positions it as an optimal candidate for addressing a spectrum of conditions, with our lead program addressing a critical need to protect military personnel and chemical incident responders.
GV104 Development: Protect Military Personnel and Chemical Incident Responders
Through Hepion’s subsidiary, Gravitas Life Sciences is seeking to develop GV104 for the proposed indication of “Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering and Area Contaminated with High-Potency Opioids”. Gravitas Life Sciences received positive feedback from the U.S. Food and Drug Administration (FDA) regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (NDA) for GV104.
The FDA has confirmed that no additional clinical trials will be required to determine the dosing window for this indication prior to NDA submission.
The foundation for the FDA’s alignment on the submission of an NDA without additional clinical trials rests on the extensive existing data related to the approved active ingredient, nalmefene, embedded in GV104. This includes a comprehensive understanding of its safety profile, established through years of use in approved products, and evidence of its effectiveness against certain opioid receptors.
Beyond Our Primary Indication: Our strategic roadmap for GV104 began with completion of our phase 1 trial and phase 2 readiness to study patients under an open IND for a specific symptom in a rare liver condition, which has since been deprioritized. Leveraging our positive feedback from FDA and an open cross-referenceable IND, we anticipate further development of GV104 in commercial applications following a more near-term NDA filing strategy for prophylaxis against ultrapotent opioid exposure.
Next Generation of Oral Infliximab
GV023: An Oral Infliximab Antibody Program
Intravenous infliximab, a TNF-alpha inhibitor, has established itself as a gold standard therapy for moderate to severe ulcerative colitis, offering significant benefits in inducing and maintaining remission in patients who have inadequate response to conventional therapies such as corticosteroids and immunosuppressants. Landmark clinical trials demonstrated that IV infliximab induction therapy followed by maintenance dosing substantially improved clinical outcomes, including remission rates and mucosal healing, while reducing the need for colectomy. Its robust efficacy profile, supported by extensive real-world evidence and long-term safety data spanning over two decades of clinical use, has made intravenous infliximab a cornerstone of treatment algorithms for moderate-to-severe UC across major gastroenterology societies and clinical practice guidelines.
GV023, an oral formulation of infliximab, addresses a critical limitation of the IV gold standard by eliminating the treatment burden of repeated intravenous infusions. By enabling patient self-administration, an oral TNF-alpha inhibitor may potentially improve medication adherence and persistence while expanding treatment access to patients who currently defer IV therapy due to infusion center barriers, needle anxiety, or lifestyle constraints. GV023 is positioned to potentially establish a new treatment option for clinicians that combine TNF inhibition’s well-established efficacy with patient-centric oral administration, theoretically reshaping UC treatment paradigms and may capture market opportunity across disease severity spectrums.
Our Pipeline
