Pharmacokinetic profile of rapid absorption and fast clearance, with a mean terminal half-life of approximately 3 to 4 minutes, is consistent with a short-acting effect

DTI-117 is being evaluated in a NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study

RESEARCH TRIANGLE PARK, N.C. – October 13, 2026 – Dignify Therapeutics (“Dignify”, the “Company”), a biopharmaceutical development company focused on restoring bowel and bladder control for people with neurological conditions, today announced preclinical safety, efficacy and pharmacokinetic (PK) data for DTI-117 in a poster presented on October 11, 2026, at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee. DTI-117 is being developed as an on-demand therapy to restore controlled evacuation in people with neurogenic bowel dysfunction (NBD).

Eight conscious minipigs (four male, four female) received intramuscular (IM) injections of DTI-117 or vehicle and were observed for defecation, urination and side effects. The study included a dose-range-finding phase (single doses of 0.01 to 3 mg/kg), a 12-day crossover phase (0.03 and 0.3 mg/kg) and a PK phase (0.1 and 1.0 mg/kg).

• Defecation responder rates increased with dose in the dose-range-finding phase, with doses above 0.03 mg/kg, producing rates significantly different from vehicle.
• In the crossover phase, both 0.03 and 0.3 mg/kg produced defecation responder rates significantly different from vehicle (p < 0.05).
• Higher doses triggered multiple defecation events within 15 minutes of a single injection.
• Urination was also induced, with dose-dependent responder rates. Latencies for both urination and defecation did not differ significantly across doses by one-way ANOVA (p > 0.05).
• Side effects (diarrhea, emesis, lethargy and flushing) occurred at higher doses and were transient.
• After IM dosing, plasma concentrations showed rapid absorption and fast clearance. Median time to peak concentration was 1.0 minute at 0.1 mg/kg (range 1-3) and 2.0 minutes at 1.0 mg/kg. Mean peak concentration was 64.0 ng/mL and 560 ng/mL, respectively. Mean terminal half-life was 2.65 minutes at 0.1 mg/kg and 3.59 minutes at 1.0 mg/kg.
• The study demonstrated NK2 receptor agonists may provide a predictable, convenient on-demand defecation therapy for constipation that is resistant to current therapies, such as refractory constipation and neurogenic bowel disease.

DTI-117 is moving into the clinic following FDA clearance of its Investigational New Drug application, announced October 7, 2026. A randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study in healthy volunteers, funded by the National Institutes of Health, is expected to begin dosing in November 2026.

“For an on-demand therapy, what matters is a response that begins within minutes and exposure that clears just as quickly. In these studies, the pharmacokinetic profile tracked the effect we observed, which is the relationship we hoped to see as we bring DTI-117 into the clinic as the potential first drug to treat constipation due to defecation dysfunction,” said Karl Thor, Ph.D., Chief Scientific Officer of Dignify Therapeutics.

“The preclinical data we presented at ACG are part of the foundation that supported FDA clearance of our IND for DTI-117, and we are pleased to share them with the gastroenterology community,” said Anthony DiTonno, Chief Executive Officer of Dignify Therapeutics. “These findings reinforce our work to give people with neurogenic bowel dysfunction, and the caregivers who support them, a more reliable way to plan bowel care. We are preparing to begin the Phase 1 study in November as we continue advancing DTI-117 toward patients.”

Poster Presentation Details

Title: Preclinical Safety, Efficacy, and PK of DTI-117, an NK2 Receptor Peptide Agonist, in Minipigs: A Proposed “Rapid-onset, Short-duration, On-Demand Defecation” Treatment for Constipation Due to Dysfunctional Defecation

Session and Time: P0808, Scientific Poster Session, Sunday October 11, 2026; 3:30-6:45 PM

Presented by: Karl B. Thor, PhD 

###

About DTI-117

DTI-117 is a novel, short-acting peptide and neurokinin-2 receptor agonist being developed by Dignify Therapeutics as an on-demand treatment for neurogenic bowel dysfunction and other bladder and bowel voiding disorders. DTI-117 is designed to produce rapid, transient emptying with a short duration of action suited to patient-controlled voiding. With the FDA clearance of the IND application, the NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study evaluating DTI-117 in healthy volunteers is expected to begin dosing healthy volunteers in November 2026.

About Dignify Therapeutics

Founded by a team of serial entrepreneurs and internationally recognized scientists, Dignify Therapeutics’ mission is to provide practical and convenient treatments for bladder and bowel voiding dysfunction, especially in people with neurogenic conditions. The Company has been supported by founders, venture capital firms, the North Carolina Biotechnology Center, the One NC Small Business Program, and the National Institutes of Health. Dignify has received 18 NIH awards and more than $20 million in NIH funding. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

DTI-117 development is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number U44NS129628. The content of this release is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

Media and Investor Contact

Anthony DiTonno

Chief Executive Officer

ditonno@dignifytherapeutics.com

Stephanie Carrington

ICR Healthcare

Stephanie.carrington@icrhealthcare.com

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NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study expected to begin dosing healthy volunteers in November 2026

Preliminary topline data from initial cohorts anticipated in early 2027

RESEARCH TRIANGLE PARK, N.C., Oct. 7, 2026 /PRNewswire/ — Dignify Therapeutics (“Dignify”, the “Company”), a biopharmaceutical development company focused on restoring bowel and bladder control for people with neurological conditions, today announced that its Investigational New Drug (IND) application for DTI-117 has been cleared by the U.S. Food and Drug Administration (FDA), allowing the Company to proceed with first-in-human clinical evaluation. DTI-117 is being developed as an on-demand therapy to restore controlled evacuation in people with neurogenic bowel dysfunction (NBD). The IND clearance marks Dignify’s transition from preclinical development into clinical-stage development.

The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-ascending-dose study designed to evaluate the safety, tolerability and pharmacokinetics of single intramuscular doses of DTI-117 in healthy volunteers. The study is funded by the National Institutes of Health (NIH).

DTI-117 is a novel drug candidate designed to induce rapid, on-demand defecation within minutes and potentially give people greater control over the timing and location of evacuation. In preclinical studies, DTI-117 has demonstrated rapid, controlled bladder and bowel emptying across multiple animal models.

People with NBD can have substantial difficulty voluntarily initiating bowel movements, which can require significant time, effort, and caregiver assistance. Current approaches, including laxatives, enemas and manual evacuation, may lack predictable timing and can be invasive or stigmatizing.

“Through extensive interactions with people with spinal cord injury and personal experience with my son, who has a C2 spinal cord injury, we designed DTI-117 around the attributes that matter most for a drug-induced defecation therapy: predictable start and stop timing, brief duration, efficient emptying, and tolerability,” said Karl Thor, Ph.D., Chief Scientific Officer of Dignify Therapeutics. “As a small peptide designed for short-acting exposure, we believe DTI-117 has the potential to deliver on these attributes and give people greater control over bowel care.”

“FDA clearance of our IND allows us to begin evaluating DTI-117 in the clinic and represents an important milestone for Dignify,” said Anthony DiTonno, Chief Executive Officer of Dignify Therapeutics. “We are on track to dose the first participant in the Phase 1 healthy volunteer trial in November and anticipate preliminary topline data from the first few cohorts in early 2027.”

About DTI-117

DTI-117 is a novel, short-acting peptide and neurokinin-2 receptor agonist being developed by Dignify Therapeutics as an on-demand treatment for neurogenic bowel dysfunction and other bladder and bowel voiding disorders. DTI-117 is designed to produce rapid, transient emptying with a short duration of action suited to patient-controlled voiding.

About Dignify Therapeutics

Founded by a team of serial entrepreneurs and internationally recognized scientists, Dignify Therapeutics’ mission is to provide practical and convenient treatments for bladder and bowel voiding dysfunction, especially in people with neurogenic conditions. The Company has been supported by founders, venture capital firms, the North Carolina Biotechnology Center, the One NC Small Business Program, and the National Institutes of Health. Dignify has received 18 NIH awards and more than $20 million in NIH funding. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

DTI-117 development is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number U44NS129628. The content of this release is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

SOURCE Dignify Therapeutics

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Mr. Welch comes to Dignify with over two decades of diverse business experience as a successful entrepreneur and business executive from startup to acquisition. He has worked as a senior executive in clinical trials for pharmaceutical, biotechnology, and med-tech companies seeking to develop their assets into safe and effective treatment options. His experience includes multiple leadership roles in business development, branding, marketing, corporate communications, and strategic planning activities.

We are thrilled to welcome Jeff to our executive team,” said Anthony DiTonno, CEO of Dignify. His skills and experience align well with Dignify’s business priorities. As we enter a pivotal phase of growth, Jeff has a wide appreciation of the complexities associated with getting a drug or device to market. From fundraising and building a team of KOLs to navigating the regulatory landscape, he will be instrumental in executing our mission to bring Dignify’s treatments to patients.

About Dignify Therapeutics

Founded by a team of serial entrepreneurs who are internationally recognized scientists, Dignify Therapeutics’ mission is to provide practical and convenient treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology.

The Company is funded by founders, venture capital firms (RA Capital Management and Eshelman Ventures), the North Carolina Biotechnology Center, the One NC Small Business Program, and the NIH SBIR/STTR program (with 18 awards and approximately $18 million in funding). Dignify Therapeutics is located in the First Flight Venture Center in Research Triangle Park, North Carolina. 

PRESS CONTACT

Dignify Therapeutics

Ed Burgard, PhD

2 Davis Drive

Research Triangle Park, NC  27709

Phone: 919-371-8138

Email:  eburgard@dignifytherapeutics.com

Website:  https://dignifytherapeutics.com

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During the conference, Dignify CEO Anthony DiTonno provided an update of the company’s progress and strategic direction. He emphasized Dignify Therapeutics’ commitment to developing innovative therapies for individuals affected by spinal cord injuries, diabetes, Parkinson’s disease, and other neurological conditions.

DTI-301 and DTI-117 are at the forefront of the company’s pipeline and are treatments for bladder and bowel dysfunction associated with neurological conditions and the aging process. Currently, many of these individuals require bladder catheterization for bladder emptying and an invasive, time-consuming manual bowel program for bowel evacuation. 

Dignify’s lead drug program, DTI-301, is a suppository that patients use as needed for bowel evacuation. DTI-301 induces defecation within 5-10 minutes, with minimal absorption and systemic exposure.  Dignify’s second drug program, DTI-117, is currently in development for on-demand emptying of both the bladder and bowel. DTI-117 directly stimulates smooth muscle contraction in the bladder and bowel, produces voiding in less than 10 minutes, and is rapidly eliminated from the body.

About Dignify Therapeutics

Dignify Therapeutics is a biotechnology company focused on developing therapies to restore voluntary bowel and bladder function in individuals with neurological conditions. The company’s mission is to improve the quality of life for individuals affected by neurological disorders, and the elderly.

For more information about Dignify Therapeutics and its clinical development programs, please visit www.dignifytherapeutics.com.

About the BIO CEO & Investor Conference

The BIO CEO & Investor Conference serves as a premier platform for biotech companies to engage with investors and industry leaders, fostering discussions on the latest advancements and investment opportunities in the biotechnology sector. 

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RESEARCH TRIANGLE PARK, NC (October 22, 2024) – Dignify Therapeutics (Dignify), a leading developer of therapies for bladder and bowel dysfunction, has been selected as a participating company in the Praxis Spinal Cord Injury (SCI) Accelerate Program. SCI Accelerate is a commercialization program ‘geared towards healthcare companies with a product ready to launch into a market that will transform the lives of people living
with SCI’. Under the SCI Accelerate program, Dignify and Praxis will focus on the development of Dignify’s drug programs to treat bladder and bowel disorders in people with SCI.

Dr. Karl B. Thor, Chief Scientific Officer of Dignify, indicated; “The Praxis SCI Accelerate Program is critically important for Dignify to ensure that the clinical development program for our products provides the efficacy, safety, and convenience that are considered valuable and most important by SCI individuals for control of bowel
and bladder dysfunction. The selection of Dignify to join the Praxis SCI community confirms the unmet medical need for our therapeutics.”

Arushi Raina, Praxis Director of Commercialization, stated “The Praxis team was impressed by the Dignify team’s approach and excited by the possibility of a bowel and bladder treatment that could be used in an accessible way to transform daily living.”

About Dignify Therapeutics
Founded by a team of serial entrepreneurs who are internationally recognized scientists and clinicians, Dignify’s mission is to provide safe, effective, practical, and convenient, “on-demand” pharmaceutical agents to treat bladder and bowel voiding dysfunctions. The company has been funded by RA Capital Management, Eshelman
Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA, US Defense Department, and the One NC Small Business Program. Dignify is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

About Praxis
Praxis is a Canadian-based not-for-profit organization that leads global collaboration in SCI research, innovation, and care. We accelerate the translation of discoveries and best practices into improved treatments for people with spinal cord injuries. Our work is driven by the priorities of people with SCI and led by our four teams — PLEX (people with lived experience), Cure, Care, and Commercialization.

PRESS CONTACT
Dignify Therapeutics
Anthony DiTonno, CEO
2 Davis Drive
Research Triangle Park, NC 27709
ditonno@dignifytherapeutics.com
dignifytherapeutics.com

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Dr. Karl B. Thor, Chief Scientific Officer and Investigator on the grants indicated; “We are very grateful that multiple Institutes at the NIH support the severe, unmet, medical need for therapies to restore control of bladder and bowel dysfunction. These therapies are directed toward the elderly and people with neurological conditions such as spinal injury, multiple sclerosis, spina bifida, and diabetes. The needs of these populations are typically not discussed publicly by those afflicted and their caregivers and thus remain an unrecognized and underappreciated burden for them.” He further emphasized; “Bladder and bowel dysfunction are top reasons for institutionalization of the elderly due to the heavy burdens associated with domestic caregiving. Similarly, restoration of bladder and bowel dysfunction in people with spinal injury is more important to them than restoration of their ability to walk.“

The new grants will allow Dignify to expand its therapeutic research and development efforts into providing innovative drug therapies for treating urinary and fecal incontinence, respectively. Similar to the unmet medical need for drugs to induce on-demand voiding in the elderly and people with neurological conditions, there is also a severe need in these same populations to prevent incontinence episodes. Dr. Qiaojuan Zhang, Principal Investigator on grant R43AG088838, will join Dignify from Duke University Department of Neurology to lead the NIA-sponsored research.

About Dignify Therapeutics

Founded by a team of serial entrepreneurs who are internationally recognized scientists and clinicians, Dignify’s mission is to provide safe, effective, practical and convenient, “on-demand” pharmaceutical agents to treat bladder and bowel voiding dysfunctions. The company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA, US Defense Department, and the One NC Small Business Program. Dignify is located at the First Flight Venture Center in Research Triangle Park, North Carolina. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

PRESS CONTACT

Dignify Therapeutics
Anthony DiTonno, CEO
2 Davis Drive
Research Triangle Park, NC 27709
ditonno@dignifytherapeutics.com
dignifytherapeutics.com

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“I am extremely excited to join Dignify’s SAB. Having lived with a spinal injury for almost 40 years, and experience daily chronic bladder and bowel dysfunction, I am grateful that there is a company that is dedicated to finding new pharmaceutical approaches for bladder and bowel treatments for people with spinal cord injury, multiple sclerosis, and other neuropathies”, Sasha explained. “I look forward to providing Dignify with direction for their clinical trial designs and product development that includes guidance from those living with spinal injury/disease.”

“We are very proud to have Sasha join Dignify’s SAB. We look forward to his guidance and expertise as we focus on advancing our therapies for the treatment of bladder and bowel disorders, especially as they apply to people with neurological deficits such as spinal injury,” said Dr. Karl Thor, Chief Scientific Officer of Dignify. “I am confident that Dr. Rabchevsky will be a significant contributor to our development of novel treatments that will allow people with spinal injury, neurological disease, diabetes, and the elderly to regain ‘on-demand’ control of bladder and bowel voiding to eliminate many of the associated social, professional, financial, and physical burdens of bladder and bowel dysfunction.”

About Dignify Therapeutics

Founded by a team of serial entrepreneurs who are internationally recognized scientists and clinicians, Dignify’s mission is to provide safe, effective, practical and convenient, “on-demand” pharmaceutical agents to treat bladder and bowel voiding dysfunctions. The company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA, US Defense Department, and the One NC Small Business Program. Dignify is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

PRESS CONTACT

Dignify Therapeutics
Anthony DiTonno, CEO
2 Davis Drive
Research Triangle Park, NC 27709
ditonno@dignifytherapeutics.com
dignifytherapeutics.com

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Dr. Karl Thor, Chief Scientific Officer and patent co-inventor stated “This is an important accomplishment for the company as we expand our portfolio of treatments for individuals with voiding disorders.  This patent helps solidify our mission to restore voluntary “on demand” bladder and bowel voiding to those patients that are unable to voluntarily void or voluntarily control bladder or bowel activity.”  Dr. Aura Kullmann is also a co-inventor.

Many individuals with spinal cord injury, multiple sclerosis, spina bifida, Parkinson’s disease, diabetes as well as many elderly people cannot completely or efficiently empty their bladder or bowel without the assistance of bladder catheters or bowel programs.  Dignify’s US Patent No. 10,086,034 describes a method of drug-induced voiding that could potentially replace bladder catheters and bowel programs, thus improving the standard of care and quality of life for individuals that experience voiding dysfunction.

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunction. The Company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA and the One NC Small Business Program. Dignify, a member of the Blackstone Entrepreneur Network, is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

PRESS CONTACT
Dignify Therapeutics
Ed Burgard, President
P.O. Box 13169 – 2 Davis Drive
Research Triangle Park, NC  27709
Phone: 919-371-8138
Email:  eburgard@dignifytherapeutics.com
Website:  https://dignifytherapeutics.com

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