Keenova Advances Podiatry Pipeline with First Patient Dosed in Phase 3 Trial of XIAFLEX® (collagenase clostridium histolyticum) for Hammer Toe

Rhea-AI Summary

Keenova Therapeutics (NYSE: MNK) reported that the first patient has been enrolled and dosed in KN3835-313, a randomized, double-blind, placebo-controlled Phase 3 trial of XIAFLEX (collagenase clostridium histolyticum) as an investigational nonsurgical treatment for adult hammer toe.

The study will assess efficacy, safety, and tolerability in approximately 550 participants across about 35 U.S. sites. The primary endpoint measures improvement in toe straightening via reduction of flexion contracture at the proximal interphalangeal (PIP) joint, with secondary endpoints covering foot function, activity limitations, and patient-assessed hammer toe severity.

Keenova highlights that no FDA-approved nonsurgical therapies are currently indicated for hammer toe. XIAFLEX remains investigational for this indication, although it is already FDA-approved for other urological and orthopedic conditions.

Positive

• Phase 3 hammer toe trial initiated with first patient dosed
• Planned enrollment of approximately 550 participants at about 35 U.S. sites
• Targets indication with no FDA-approved nonsurgical therapies currently available
• Randomized, double-blind, placebo-controlled design supports robust efficacy and safety assessment

Negative

• XIAFLEX is investigational and not FDA-approved for hammer toe
• Clinical and regulatory outcomes remain uncertain at early Phase 3 stage
• Forward-looking statements highlight risks including regulatory actions, safety issues, and supply or manufacturing problems

Key Figures

Trial Phase: Phase 3 Planned Enrollment: approximately 550 participants Study Sites: estimated 35 sites +3 more

6 metrics

Trial Phase Phase 3 XIAFLEX hammer toe trial

Planned Enrollment approximately 550 participants KN3835-313 Phase 3 trial

Study Sites estimated 35 sites United States Phase 3 trial

ClinicalTrials.gov Identifier NCT07759362 KN3835-313 study registration

U.S. Diagnosed Adults approximately 2 million adults 2025 hammer toe claims data

Claims Data Year 2025 U.S. medical and pharmacy claims analysis

Key Terms

collagenase clostridium histolyticum, double-blind, randomized, placebo-controlled, flexion contracture, proximal interphalangeal

4 terms

collagenase clostridium histolyticum medical

"XIAFLEX® (collagenase clostridium histolyticum) as an investigational"

An injectable enzyme produced from the bacterium Clostridium histolyticum that breaks down excess collagen in scar-like tissue, used to treat certain fibrous disorders. Think of it as microscopic scissors that cut the tough connective fibers causing abnormal lumps or contractures. It matters to investors because its approval, patent protection, manufacturing complexity, and clinical effectiveness directly affect a drug maker’s sales potential, regulatory risk, and competitive position in the market.

double-blind, randomized, placebo-controlled technical

"is a double-blind, randomized, placebo-controlled study designed to evaluate"

A double-blind, randomized, placebo-controlled study is a medical test where participants are randomly assigned to receive either the experimental treatment or an inactive substitute (placebo), and neither the participants nor the researchers know who got which until the study ends. Like a blind taste test, this setup reduces bias and chance results, so investors can have greater confidence that reported effects reflect the treatment itself rather than expectations or selection quirks.

flexion contracture medical

"by reducing the flexion contracture of the proximal interphalangeal (PIP) joint"

A flexion contracture is a medical condition in which a joint becomes stuck in a bent position because surrounding muscles, tendons, ligaments, or scar tissue have tightened, preventing the joint from straightening fully. It matters to investors because its presence, severity, and rate of occurrence influence demand for treatments, device design, clinical trial outcomes, regulatory approvals, and potential market size—similar to a door that can only open partway because its hinge is frozen.

proximal interphalangeal medical

"contracture of the proximal interphalangeal (PIP) joint"

The proximal interphalangeal (PIP) joint is the middle joint of a finger or toe, located between the first (proximal) and second (middle) bone segments. As a small hinge-like joint that commonly suffers injury, arthritis, or deformity, it matters to investors because treatments, implants, therapies, and rehabilitation devices targeting PIP problems can drive sales and clinical development in orthopedics, hand surgery, and musculoskeletal care markets.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• First registered, randomized Phase 3 trial evaluating the efficacy, safety, and tolerability of XIAFLEX in adults with hammer toe
• No FDA-approved nonsurgical therapies currently indicated for the treatment of hammer toe
• Hammer toe treatment today is limited to mainly orthotics, painkillers, or surgery

DUBLIN, Aug. 20, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that the first patient has been successfully enrolled and received study treatment in its Phase 3 clinical trial evaluating XIAFLEX^® (collagenase clostridium histolyticum) as an investigational nonsurgical treatment for patients with hammer toe.

While conservative management and surgical intervention are available, there are currently no FDA-approved nonsurgical therapies indicated for the treatment of hammer toe.

"We are pleased to reach this important development milestone with the first patient dosed in our Phase 3 hammer toe study," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "This musculoskeletal condition can impair foot function and limit mobility, which may impact patients' quality of life. We believe XIAFLEX has the potential to address a significant unmet need for patients seeking a nonsurgical treatment approach and look forward to evaluating its clinical efficacy, safety, and tolerability in this pivotal study."

XIAFLEX is currently approved by the U.S. Food & Drug Administration for urological and orthopedic conditions. XIAFLEX is investigational for the treatment of hammer toe and has not been approved by the FDA for this indication.

About KN3835-313
The Phase 3 trial, KN3835-313, is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of XIAFLEX in the treatment of hammer toe.

The primary endpoint evaluates whether XIAFLEX improves the ability to straighten the affected toe by reducing the flexion contracture of the proximal interphalangeal (PIP) joint. Secondary objectives include changes in foot function, activity limitations, and participants' assessment of overall hammer toe severity.

The study is expected to enroll approximately 550 participants across an estimated 35 sites in the United States.

This study is registered on ClinicalTrials.gov under the identifier NCT07759362.

About Hammer Toe
Hammer toe is a foot deformity in which one or more toes, most commonly the second toe, bend downward at the middle joint due to flexion, or contracture, of the proximal interphalangeal (PIP) joint, creating a hammer-like appearance.^1,2 The musculoskeletal condition is more common in women and is frequently seen in adults, particularly older adults.^2,3 The condition is driven by muscle-tendon imbalance, trauma, and external factors such as ill-fitting footwear, including narrow or high-heeled shoes.^1,2 Symptoms can include pain, discomfort, and difficulty walking.^1,2 Current treatment options range from conservative approaches such as footwear modification, orthoses, and exercises or physical therapy, to surgical correction in more advanced cases.^1,2 Hammer toe is one of the most common lesser toe deformities,⁴ though prevalence estimates vary greatly in scientific literature. Based on claims data, approximately 2 million adults in the U.S. were diagnosed with hammer toe in 2025.*

About Keenova 
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.

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.

Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to XIAFLEX, the efficacy, safety, potential treatments or indications, and therapeutic outcomes or treatment responses of this investigational nonsurgical treatment for patients with hammer toe, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Keenova's most recent Annual Reports on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov). The forward-looking statements made herein speak only as of the date hereof and we do 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.

* Data on file. Analysis of de-identified U.S. medical and pharmacy claims data from Komodo Health, 2025.

References

1. American Academy of Orthopaedic Surgeons. Hammer Toe: Comprehensive Guide. OrthoInfo. Accessed July 16, 2026. https://www.orthoinfo.org/diseases--conditions/hammer-toe/
2. American Podiatric Medical Association. Hammer Toes. APMA. Accessed July 16, 2026. https://www.apma.org/patients-and-the-public/conditions-affecting-the-foot-and-ankle/hammer-toes/
3. Mayo Clinic Staff. Hammertoe and mallet toe: Symptoms and causes. Mayo Clinic. Accessed July 21, 2026. https://www.mayoclinic.org/diseases-conditions/hammertoe-and-mallet-toe/symptoms-causes/syc-20350839
4. Hagedorn TJ, Dufour AB, Riskowski JL, et al. Foot Disorders, Foot Posture, and Foot Function: The Framingham Foot Study. PLoS One. 2013;8(9):e74364.

Contacts
Media:	Investors:
media.relations@keenova.com	investor.relations@keenova.com

 

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SOURCE Keenova Therapeutics

FAQ

What did Keenova Therapeutics (MNK) announce about its Phase 3 XIAFLEX hammer toe trial on August 20, 2026?

Keenova announced that the first patient has been enrolled and dosed in its Phase 3 trial of XIAFLEX for hammer toe. According to Keenova, the randomized, double-blind, placebo-controlled study will evaluate efficacy, safety, and tolerability in about 550 adults across approximately 35 U.S. sites.

What is the design and primary endpoint of Keenova’s KN3835-313 Phase 3 hammer toe study for XIAFLEX (MNK)?

The KN3835-313 trial is a double-blind, randomized, placebo-controlled Phase 3 study. According to Keenova, its primary endpoint is improvement in toe straightening, measured as reduction in flexion contracture of the proximal interphalangeal (PIP) joint, with secondary endpoints assessing foot function and activity limitations.

How many patients will be enrolled in Keenova Therapeutics’ Phase 3 XIAFLEX hammer toe trial (MNK), and where is it being conducted?

Keenova expects to enroll approximately 550 participants in its Phase 3 hammer toe study. According to Keenova, the trial will be conducted at an estimated 35 clinical sites across the United States and is registered under ClinicalTrials.gov identifier NCT07759362.

Is XIAFLEX already FDA-approved for treating hammer toe in Keenova’s MNK program?

No, XIAFLEX is investigational for hammer toe and not FDA-approved for this indication. According to Keenova, XIAFLEX is currently approved by the U.S. Food & Drug Administration only for certain urological and orthopedic conditions, not for hammer toe treatment.

Why is Keenova pursuing a Phase 3 study of XIAFLEX for hammer toe (MNK), and what unmet need does it target?

Keenova is pursuing XIAFLEX for hammer toe because there are no FDA-approved nonsurgical therapies indicated for this condition. According to Keenova, current management relies on orthotics, painkillers, footwear changes, physical therapy, or surgery, leaving an unmet need for a nonsurgical pharmacologic option.

Where can investors find more information on Keenova’s XIAFLEX hammer toe Phase 3 trial (MNK)?

Investors can review trial details under ClinicalTrials.gov identifier NCT07759362 and visit Keenova’s website. According to Keenova, its Investor Relations page is used to distribute time-critical information, including press releases and other updates relevant to the XIAFLEX hammer toe program.