Indomo partners with Lifecore to develop at-home acne treatment using ClearPen™ for upcoming clinical trials.
Quiver AI Summary
Indomo and Lifecore Biomedical have announced a new development services agreement to support Indomo's DT-001 corticosteroid drug candidate, designed for at-home treatment of inflammatory acne lesions using Indomo's ClearPen™ device. Lifecore will produce engineering and clinical batches of DT-001 in preparation for Phase 2 clinical trials set for 2026. This collaboration follows Lifecore's previous work with Indomo, focusing on formulation and process optimization for DT-001. Indomo aims to enhance accessibility to acne treatment, which affects 50 million Americans, by allowing self-administration at home, alleviating the current limitations posed by the scarcity of dermatologists. Both companies express strong enthusiasm about this partnership, emphasizing innovation and quality in their respective fields.
Potential Positives
- Indomo is advancing its DT-001 drug candidate towards Phase 2 clinical trials, indicating progress in the development of a significant treatment for inflammatory acne lesions.
- The collaboration with Lifecore emphasizes the company's commitment to innovation in injectable therapeutics and at-home treatment solutions, enhancing its market position.
- Approximately 50 million Americans are affected by acne, highlighting the potential market opportunity and demand for accessible treatment provided by Indomo's ClearPen system.
- The partnership with Lifecore, a well-established CDMO, enhances Indomo's ability to manufacture high-quality drug batches, essential for successful clinical trials and potential commercialization.
Potential Negatives
- Indomo's product, the ClearPen, is still in the investigational phase and has not received FDA approval, potentially limiting market confidence and adoption.
- The press release highlights a reliance on Lifecore for crucial manufacturing services, which may raise concerns about operational stability and dependence on a third party for product development.
- Lifecore's extensive list of risks associated with forward-looking statements could reflect uncertainties about the future success of its collaboration with Indomo and the viability of the DT-001 program.
FAQ
What is Indomo's new treatment for inflammatory acne lesions?
Indomo is developing DT-001, a corticosteroid treatment for inflammatory acne lesions, to be used with their ClearPen™ device.
How does the ClearPen™ work for acne treatment?
The ClearPen™ combines a proprietary self-injection device with a microneedle to enable at-home administration of corticosteroids.
Who is manufacturing the drug for Indomo?
Lifecore Biomedical is responsible for manufacturing drug batches of DT-001 to support Indomo's clinical trials.
What clinical trials are planned for DT-001?
Indomo plans to advance DT-001 into Phase 2 clinical trials in 2026 to evaluate its efficacy for treating acne.
What are the benefits of Indomo's at-home treatment approach?
The at-home treatment approach aims to improve access to care for patients suffering from inflammatory acne lesions.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Indomo Developing Fast-Acting, At-Home Treatment for Inflammatory Acne Lesions to be Administered with the ClearPen ™ , its Proprietary Intradermal Self-Injection Device
Lifecore to Manufacture Drug Batches in Preparation for Planned Clinical Trials
CHASKA, Minn. and BOSTON, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR ) (“Lifecore”), a fully integrated injectables contract development and manufacturing organization (“CDMO”), and Indomo, a clinical-stage company dedicated to expanding access to quality healthcare via innovative device-enabled therapeutics, today announced that the companies have entered into a new development services agreement through which Lifecore will provide Indomo with a range of CDMO services to support the continued development of its corticosteroid drug candidate, DT-001. Indomo is developing DT-001 to be combined with its investigational intradermal self-injection device, the ClearPen ™ , as a treatment for inflammatory acne lesions.
This represents the second agreement signed by the companies, with Lifecore having previously been selected to provide formulation and process optimization activities in support of the DT-001 program. Under the terms of the latest agreement, Lifecore will be responsible for producing and supplying engineering and clinical batches of DT-001 to Indomo for planned studies designed to prepare the product for anticipated advancement into Phase 2 clinical trials in 2026.
“We are thrilled to continue to grow our relationship with Indomo and support a customer that possesses such high-quality leadership and ambitious plans for innovation. 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,” said Paul Josephs, president and chief executive officer of Lifecore. “We are excited to get to work on producing engineering and clinical batches for Indomo and supporting the company’s plans to move into Phase 2 studies.”
Built by a team with deep expertise in medical devices, consumer health, and skincare, Indomo’s investigational ClearPen system pairs a proprietary self-injection device and microneedle with a modernized formulation of triamcinolone acetonide to enable consistent dosing for at-home administration.
Intralesional injections of triamcinolone acetonide, a corticosteroid backed by more than 50 years of clinical use and a strong safety profile, are recommended as one of the first-line treatments for acne by the American Academy of Dermatology. Acne is the most common skin condition in the U.S., affecting 50 million Americans annually , yet only one million people are regularly receiving corticosteroid injections to treat their inflammatory lesions. The root cause of this issue is accessibility. With only 12,000 dermatologists in the U.S ., there is only one dermatologist for every 28,000 Americans. Indomo aims to improve access by pursuing an at-home approach intended to empower patients with timely access to care.
“As we progress toward Phase 2 studies, it was critical for Indomo to partner with a CDMO that combines technical excellence with a forward-looking approach to innovation. 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. We are excited to deepen this collaboration as we move into the next phase of development,” said Rick Bente, chief executive officer of Indomo.
About Lifecore Biomedical
Lifecore Biomedical, Inc. (Nasdaq:
LFCR
) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at
www.lifecore.com
.
About Indomo
Indomo is reimagining clinical dermatology with trusted science and precision technology, bringing medical-grade care into the home. A clinical-stage therapeutics company, Indomo pairs proven medicines with novel delivery systems to create fast-acting, self-administered treatments for inflammatory skin conditions. Its debut product, the ClearPen, will combine an established, trusted therapeutic with a novel microneedle device for at-home acne treatment. Indomo is backed by leading investors including Atomic, Foresite Capital, and Polaris Partners. Founded by leaders from Hims & Hers, Medtronic, and Starface, Indomo brings together deep expertise in telehealth, medical devices, and consumer skincare. To learn more about Indomo and their Phase 2 clinical trials, head
here
.
Disclaimer : The Indomo ClearPen has not yet been approved or cleared by the U.S. Food and Drug Administration and is considered investigational; preparations are underway for Phase 2 clinical trials.
Important Cautions Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding future events and Lifecore’s future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding Lifecore’s expansion of Lifecore’s CDMO business, broadening of Lifecore’s commercial customer base, the anticipated advancement of Indomo’s DT-001 program into Phase 2 clinical trials in 2026, our efforts to expand beyond Lifecore’s traditional focus in ophthalmic therapies, enhancing Lifecore’s leadership in rapidly growing autoinjector technologies, Lifecore’s forward-looking approach to innovation, Lifecore’s expanding leadership in injectable therapeutics, and Lifecore’s commitment to speed and high-quality execution are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, the timing and amount of future expenses, revenue, net income (loss), Adjusted EBITDA, cash flow and capital requirements, and timing and availability of and the need for additional financing; Lifecore’s ability to maintain or expand Lifecore’s relationships with Lifecore’s current customers, including the impact of changes in consumer demand for the products Lifecore manufactures for Lifecore’s customers; Lifecore’s ability to grow and diversify Lifecore’s business with new customers, including the potential loss of development customers or delays in our development customers’ programs if they do not receive required funding or regulatory approvals, or for other reasons; Lifecore’s ability to comply with covenants under Lifecore’s credit agreements and to pay required interest and principal payments when due; Lifecore’s ability to fund any redemptions of shares of its outstanding Series A Convertible Preferred Stock if requested by holders in accordance with their terms; Lifecore’s ability to raise additional capital for ongoing needs, including through equity financing, debt financing, collaborations, strategic alliances or licensing arrangements; the impact of macroeconomic events or circumstances on Lifecore’s operations and financial performance, including inflation, tariffs, interest rates, social unrest and global instability; the performance of Lifecore’s third-party suppliers; pharmaceutical industry market forces that may impact Lifecore’s customers’ success and continued demand for the products Lifecore produces for those customers; Lifecore’s ability to recruit or retain key scientific, technical, business development, and management personnel and Lifecore’s executive officers; Lifecore’s ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including current Good Manufacturing Practice, or cGMP; the outcome and cost of existing and any new litigation or regulatory proceedings; and other risk factors set forth from time to time in the company’s filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the Annual Report on Form 10-K for the year ended May 25, 2025 (the “2025 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Lifecore’s filings with the SEC, including the risk factors contained in the 2025 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, Lifecore does not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.
Lifecore Biomedical, Inc. Contact Information:
Vida Strategic Partners
Stephanie Diaz (Investors & Media)
415-675-7401
[email protected]
Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
[email protected]