Noveome Biotherapeutics Announces Positive Data Safety Monitoring Board Recommendation in ongoing NEC Clinical Trial

Drug Safety Monitoring Board (DSMB) gives Noveome Biotherapeutics a recommendation to continue the Necrotizing Enterocolitis (NEC) study without modifications

PITTSBURGH, PA, UNITED STATES, March 26, 2026 /EINPresswire.com/ -- Noveome Biotherapeutics, Inc, a clinical-stage biotechnology company focused on developing innovative therapies for rare and life-threatening conditions, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from Cohort 1 of the ongoing clinical trial evaluating ST266 for the treatment of necrotizing enterocolitis (NEC) in neonates.

Following its review, the DSMB recommended that the study continue without modifications, noting no safety concerns in any of the infants treated with ST266 in the first Cohort of this groundbreaking trial.

“The DSMB’s unanimous recommendation to proceed without changes, along with the absence of any safety concerns, represents an important milestone for this program,” said Patrick Welch, CEO of Noveome Biotherapeutics. “These findings support continued advancement of ST266 into the next cohorts of this study, including both dose escalation and expansion into additional patient populations.”

Based on this positive recommendation, the Company plans to proceed with:
• Cohort 2, which will evaluate an increased dose of ST266 (1 mL/kg body weight) in infants weighing greater than 1000 to 3000 grams; and
• Cohort 3, which will evaluate the 0.5mL/kg body weight dose of ST266 in smaller infants weighing 500 to 999 grams, a particularly vulnerable population affected by NEC.

As previously agreed with by the U.S. Food and Drug Administration (FDA), Cohorts 2 and 3 will be conducted simultaneously.

The DSMB is composed of independent neonatologists and physicians with extensive experience in the treatment of NEC. The board is responsible for ongoing safety oversight throughout the trial.

The Company has received the DSMB’s formal written recommendation and has promptly notified clinical trial sites to initiate enrollment in Cohorts 2 and 3, as patients present and meet the eligibility criteria.

About Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a devastating gastrointestinal disease that primarily affects premature infants weighing less than 1500 grams and is associated with significant morbidity and mortality. “There remains a critical unmet need for safe and effective therapies for NEC, as we haven’t seen a significant therapy developed for this terrible disease in over 40 years,” according to Dr. Potoka, a practicing Neonatologist and CMO of Noveome Biotherapeutics.

About ST266
ST266, a novel multi-component biologic secretome derived from human amnion epithelial cells, has demonstrated protective anti-inflammatory, anti-apoptotic in experimental mouse and piglet NEC models through reduction of TLR4 activity. Strikingly, ST266 upregulated critical genes associated with gut remodeling, intestinal immunity, gut differentiation and energy metabolism. ST266 is currently being evaluated in an ongoing clinical trial (NCT06315738) assessing safety and preliminary efficacy in Bell Stage 2A–3A neonatal NEC patients.

About Noveome Biotherapeutics
Noveome Biotherapeutics, Inc. is a clinical stage, Pittsburgh-based biotechnology company advancing the development of ST266, a proprietary, amnion cell-derived secretome platform. ST266 is designed to utilize physiologic paracrine signaling to promote cellular survival and tissue repair through complementary anti-inflammatory, anti-apoptotic, neuroprotective, maturational and regenerative mechanisms.

Noveome’s therapeutic focus includes rare pediatric diseases like NEC, ophthalmology, neurology and other CNS disorders, inflammatory conditions, and tissue injury and repair, with potential expansion into additional indications where a multi-target, biologic approach may offer a meaningful clinical benefit.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including, without limitation, statements regarding the continued development of ST266, the initiation, enrollment, and anticipated timing of Cohorts 2 and 3 of the Company's clinical trial evaluating ST266 for the treatment of NEC, the potential safety and therapeutic benefit of ST266, expectations regarding regulatory interactions with the FDA, and the Company's plans and strategies for its clinical programs. Words such as "expects," "anticipates," "plans," "believes," "potential," "will," and similar expressions are intended to identify forward-looking statements. These statements are based on management's current expectations, assumptions and beliefs and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

Gretchen Kraemer
Noveome Biotherapeutics, Inc.
+1 412-402-9914
gkraemer@noveome.com
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