Company Overview

Company Description

We are a biotechnology company developing small molecule oral therapeutics for immune-mediated inflammatory diseases, or IMIDs. Our aim is to develop oral, safe and effective small molecule therapies that control inflammation, prevent tissue damage, improve quality of life and achieve long-term disease remission. We believe that the lack of an in-depth understanding of the pathophysiological mechanisms underlying immune-mediated inflammation has restricted therapeutic options for several IMIDs to merely symptomatic interventions, with limited effectiveness. Our drug discovery and development approach combines artificial intelligence, or AI, and machine learning, or ML, with our team’s extensive experience and expertise, to decode the mechanisms and pathways that drive the initiation and progression of inflammation for patients with IMIDs. We currently have two product candidates, INVA8001, which we plan to progress into Phase 2b of clinical development, and INVA8003, which is in early stage preclinical development. We believe that our product candidates, INVA8001 and INVA8003, if approved, can potentially transform the treatment of several IMIDs, such as atopic dermatitis, or AD, and chronic urticaria, or CU, which are characterized by limited or no available therapeutic options or patient populations that are unresponsive, partially responsive or develop resistance to currently available therapies. INVA8001 is designed as an oral, small molecule, highly selective and potent inhibitor of chymase, a key mediator of mast cells driving inflammation, epithelial barrier damage and fibrosis.

We in-licensed INVA8001 from Daiichi Sankyo Company, Limited, or Daiichi. INVA8001 has undergone extensive preclinical and clinical testing for use in the treatment of AD, and has demonstrated a well characterized pharmacokinetic, or PK, profile and was well-tolerated in a single ascending dose, or SAD, trial, a multiple ascending dose, or MAD, trial, and a Phase 2 clinical trial conducted by Daiichi. All previous clinical trials of INVA8001 were conducted by Daiichi. We have not completed any clinical trials of INVA8001 to date. While Daiichi’s Phase 2 trial in AD did not meet the primary efficacy endpoint, we have closely analyzed the Phase 2 trial data and we believe we have identified potential gaps in that trial’s design. Subject to clearance by the U.S. Food and Drug Administration, or FDA, of an investigational new drug, or IND, application, we plan to conduct a Phase 2b trial with a new trial design for INVA8001. We expect our Phase 2b trial will include a higher dosage and different dosing regimen of INVA8001, extended treatment duration and enrollment of AD subjects using well-defined selection criteria, including enriching for subjects with high levels of immunoglobulin E, or IgE, antibodies as a marker for mast cell activation and allergic inflammation. INVA8003 is a de-novo small molecule multi-inflammasome inhibitor that has shown strong inhibition of a key pro-inflammatory marker for several IMIDs in early preclinical testing.

We plan to submit an IND application to the FDA for INVA8001 in AD in 2024 and, if cleared, initiate a Phase 2b trial for moderate to severe AD thereafter. We plan to initiate a Phase 1b trial for INVA8001 in CU in 2024, subject to regulatory clearance. We are currently conducting IND-enabling studies for INVA8003, and we intend to start good laboratory practice, or GLP, toxicology studies in 2024.

IMIDs encompass a clinically diverse range of unrelated conditions that share common inflammatory pathways and are characterized by disruptions in cellular homeostasis driven by common immune pathways and genetic factors. The prevalence of IMIDs is significant. Commonly known IMIDs include rheumatoid arthritis, the spondyloarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions (including psoriasis and AD), inflammatory bowel disease, asthma and autoimmune neurological diseases such as multiple sclerosis. Based on research available on the estimated population affected by each of these commonly known IMIDs, we estimate approximately 64 million individuals in the United States are living with a commonly known IMID. We also estimate more than 25 million individuals in the United States are living with AD, of which approximately 30% have moderate AD and approximately 10% have severe AD, which corresponds to approximately 10 million patients with moderate or severe AD in the United States. A feature of many IMIDs is the strong induction or dysregulation of an inflammatory response that begins with inflammasome activation and can eventually progress to matrix remodeling and fibrosis. Targeting and correcting a dysregulated inflammatory response to effectively address IMIDs may present a significant opportunity to develop novel and potentially transformative treatments.

Treatment options for IMIDs have historically relied heavily on glucocorticoids and other small chemical compounds as well as, for skin IMIDs, topicals. More recent advances have led to the development of immune-targeted therapeutics, such as biological agents and small molecule-based therapies, including kinase inhibitors and immunomodulators. The current treatments have significant limitations, including: safety issues due to potential for significant side effects; inadequate response; immunogenicity; withdrawal/ rebound; compliance issues due to inconvenient or invasive dosing regimens; and high cost, especially for biologics.

There continues to be an unmet need for oral, safe and effective small molecule therapies for the treatment of IMIDs.

We were incorporated under the laws of the state of Delaware on October 20, 2021, under the name Invea Therapeutics, Inc. The Company is a controlled subsidiary of InveniAI. We expect that InveniAI will cease to be our controlling shareholder following this offering. InveniAI is a technology company that uses artificial intelligence and machine learning to drive innovation across drug discovery and development, and is a wholly owned subsidiary of BioXcel LLC (formerly BioXcel Corporation). Our principal executive offices are located at 2614 Boston Post Road Suite 33AR, Guilford CT 06437, USA, and our telephone number is (203) 643-8060. Our website address is www.inveatx.com.