Oklahoma City, OK
Altheus Therapeutics, Inc. is developing Zoenasa™ Oral Controlled Release and Rectal Gel formulations as novel front-line therapies for the treatment of inflammatory bowel disease (IBD) with the initial focus on ulcerative colitis (UC). Zoenasa is a fixed-dose combination of the anti-inflammatory mesalamine (5-aminosalicylic acid; 5-ASA) plus a powerful antioxidant to reduce bowel injury associated with IBD. Zoenasa is formulated as a rectal gel enema to improve efficacy in patients suffering from left-sided (distal) ulcerative colitis; and as oral formulations with an extended- and delayed-release profile for patients with proximal or extensive colitis.
Altheus has completed a preclinical safety toxicology program in 3 animal species along with a Phase 1, two-dose study of the safety and tolerability of Zoenasa Rectal Suspension in adult patients. Altheus is preparing to initiate a Phase 2 clinical trial to establish the efficacy of Zoenasa Rectal Suspension in patients with left-sided UC (ZA-201). The Zoenasa Oral controlled release products have completed initial formulation work and are ready to begin final formulation development activities, followed by clinical trials.
Altheus has raised over $8.5 million in a two tranche Series B financing to complete ZA-201 (a Phase 2 efficacy study of Zoenasa Rectal Suspension in adult subjects with left-sided ulcerative colitis) and supportive corporate activities.