Lifecore Biomedical Expands Partnership with Indomo to Advance At-Home Acne Treatment Device
核心洞察
Lifecore Biomedical has signed a second development services agreement with Indomo (搜索) to manufacture clinical batches of DT-001, a corticosteroid drug candidate for inflammatory acne treatment.
Indomo (搜索)'s investigational ClearPen system combines triamcinolone acetonide with a proprietary self-injection device and microneedle for at-home administration.
The partnership aims to prepare DT-001 for Phase 2 clinical trials in 2026, addressing a significant access gap where only one million of 50 million Americans with acne receive corticosteroid injections.
Lifecore Biomedical Inc has entered into a second development services agreement with clinical-stage company Indomo (搜索) to support the continued development of DT-001, a corticosteroid drug candidate designed for at-home treatment of inflammatory acne lesions. The expanded partnership will see Lifecore produce engineering and clinical batches of DT-001 in preparation for anticipated Phase 2 clinical trials in 2026.
Novel Drug-Device Combination Addresses Access Gap
Indomo (搜索)'s investigational ClearPen system represents a novel approach to acne treatment, pairing a proprietary self-injection device and microneedle with a modernized formulation of triamcinolone acetonide. The system is designed to enable consistent dosing for at-home administration, addressing a significant accessibility challenge in dermatological care.
Despite acne being the most common skin condition in the United States, affecting 50 million Americans annually, only one million people regularly receive corticosteroid injections to treat their inflammatory lesions. This treatment gap stems from limited access to dermatologists, with only 12,000 dermatologists serving the entire US population—approximately one dermatologist for every 28,000 Americans.
Established Therapeutic Foundation
The ClearPen system builds on triamcinolone acetonide, a corticosteroid with more than 50 years of clinical use and a strong safety profile. Intralesional injections of triamcinolone acetonide are recommended as one of the first-line treatments for acne by the American Academy of Dermatology, providing a solid scientific foundation for Indomo (搜索)'s at-home approach.
Strategic Partnership Expansion
This latest agreement represents the second collaboration between the companies, with Lifecore having previously provided formulation and process optimization activities for the DT-001 program. Under the new terms, Lifecore will be responsible for producing and supplying engineering and clinical batches to support planned studies designed to advance the product into Phase 2 clinical trials.
"We are thrilled to continue to grow our relationship with Indomo (搜索) and support a customer that possesses such high-quality leadership and ambitious plans for innovation," said Paul Josephs, president and chief executive officer of Lifecore. "This work with Indomo highlights the success of our continued efforts to expand beyond our traditional focus in ophthalmic therapies, while also enhancing our leadership in rapidly growing autoinjector technologies."
Clinical Development Timeline
The partnership positions both companies for the next phase of clinical development, with Phase 2 studies planned for 2026. Rick Bente, chief executive officer of Indomo (搜索), emphasized the importance of selecting the right manufacturing partner for this critical stage.
"As we progress toward Phase 2 studies, it was critical for Indomo (搜索) to partner with a CDMO that combines technical excellence with a forward-looking approach to innovation," Bente said. "Lifecore's expanding leadership in injectable therapeutics and their commitment to speed and high-quality execution position them as a key partner in advancing our therapeutic pipeline."
Company Backgrounds
Lifecore Biomedical operates as a fully integrated contract development and manufacturing organization, offering specialized capabilities in the development, fill and finish of sterile injectable pharmaceutical products. The company brings more than 40 years of expertise as a leading manufacturer of premium, injectable-grade hyaluronic acid.
Indomo (搜索), founded by leaders from Hims & Hers, Medtronic, and Starface, combines expertise in telehealth, medical devices, and consumer skincare. The clinical-stage therapeutics company is backed by leading investors including Atomic (搜索), Foresite Capital (搜索), and Polaris Partners (搜索), and focuses on pairing proven medicines with novel delivery systems for inflammatory skin conditions.