Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual Meeting

• Previously unpublished clinical data support the potential long‑term safety and efficacy of collagenase clostridium histolyticum (CCH) for plantar fibromatosis.
• The findings will be presented at the ACFAS Annual Meeting, highlighting progress toward a potential nonsurgical treatment option for a painful condition.
• Keenova's Phase 3 clinical trial is currently underway, with results expected mid-2026.

DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Keenova Therapeutics plc is presenting clinical data on plantar fibromatosis at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting, taking place February 24–27, 2026.

Why It Matters

Plantar fibromatosis is a progressive condition with no FDA-approved nonsurgical treatment options. Keenova is investigating collagenase clostridium histolyticum (CCH) as a potential therapy. CCH is not approved for treating plantar fibromatosis.

News You Should Know

New findings from Study 306, an open‑label extension of Keenova's phase 2 trial analysis show:

• Patients receiving initial treatment or re‑treatment with CCH demonstrated a safety profile consistent with the earlier phase 2 study.
• Data support the potential long‑term safety, efficacy, and durability of CCH in plantar fibromatosis.
• Keenova's Phase 3 clinical trial evaluating CCH for plantar fibromatosis is currently underway, with results expected mid-2026.

CSO Perspective

"We are pleased to share with the medical community these important data that help advance our understanding of this burdensome condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "We are progressing our program to pivotal Phase 3 study to advance a potential nonsurgical treatment option for patients with plantar fibromatosis, reinforcing our commitment to bring new therapies for challenging conditions."

Zoom in: About Study 306

• Builds on earlier phase 2 results showing improvements in nodule hardness, consistency, and other clinical measures, including the reduction of pain associated with the condition.
• Participants entered a 180‑day observation period without treatment, followed by an optional treatment phase for new or previously treated nodules.
• Participants who chose not to be retreated continued in long‑term observation without receiving additional treatment.
• The primary endpoint was safety.
• Additional efficacy was evaluated using patient‑ and investigator‑reported outcomes.

Presentation Details

• Title: Long-term safety, efficacy, and durability of collagenase clostridium histolyticum (CCH) in the treatment and re-treatment of plantar fibromatosis (PFI)
• Authors: C. James Anderson, DPM; Jason Levy, DPM, FACFAS; Sara E. Suttle, DPM, FACFAS; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; Joseph Caporusso, DPM

About Plantar Fibromatosis
Plantar fibromatosis or Ledderhose disease is a hyperproliferative fibrous tissue disorder resulting in the formation of collagen nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot, which is often painful. There is no cure for plantar fibromatosis. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.

About Keenova 
Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

The Company's diversified brands portfolio is focused across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology. Globally headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. To learn more, please visit www.keenova.com.

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The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, its Quarterly Report on Form 10-Q for the quarterly period ended March 28, 2025, its Quarterly Report for the quarterly period ended June 27, 2025,  its Quarterly Report for the quarterly period ended September 26, 2025, its Registration Statement on Form S-4, as amended, filed with the SEC, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. Given these uncertainties, one should not put undue reliance on any forward-looking statements.

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