Enterocolitis, Necrotizing

IBT has conducted a phase III study comprising 2153 premature infants for five years. The objective of the study has been to show that the company's drug candidate IBP-9414, a bacterial strain found naturally in human breast milk, can improve the health of premature infants by preventing necrotizing enterocolitis (NEC) and improve premature infants' gastrointestinal function (measured as time to Sustained Feeding Tolerance, SFT) and, as a secondary objective, reduce death. The results of the study have now been analyzed according to the pre-specified statistical analysis plan. Although these analysis showed positive trends, there were no statistical significance for the two primary endpoints: prevention of necrotizing enterocolitis (NEC), active group: 8.7% vs placebo group: 10.2% (p=0.24) and SFT, active group: 16 days vs placebo group: 17 days (p=0.07). Importantly, there was a significant reduction in the secondary endpoint of all-cause mortality, active group: 6.2% vs placebo group: 8.5% (p=0.04), corresponding to a significant risk reduction of 27%, which meant that in reality 23 infants’ lives were spared by the administration of IBP-9414 in the study. IBT will continue the development towards pharmaceutical registration, considering that the study showed statistical significance on all-cause mortality. The previous communicated timeline for the registration might be affected and IBT will revert with an update if any changes will occur. The risk reduction of 27% in mortality is a substantial effect size and comparable to currently available pharmaceutical products, for example, surfactants used in the neonatal intensive care units. The effect of IBP-9414 could potentially save the lives of thousands of infants per year and is the only Live Biopharmaceutical candidate that has shown a strong advantage in saving premature infants’ lives. Furthermore the study shows that giving IBP-9414 to these very vulnerable premature infants does not cause any safety issues, including the risk of sepsis which has been a concern expressed by the FDA for the use of probiotic products in preterm infants. “It is becoming clear to the scientific community that NEC is a poorly defined diagnosis representing several different processes. This is the likely reason for the results obtained on the NEC endpoint. Regarding the SFT endpoint, feeding patterns between intensive care units differed more than expected, which could explain the SFT results. The observed difference of 27% in lowered mortality in the active group is exciting and cannot be ignored,” says Josef Neu, Professor of Pediatrics at the University of Florida and principal investigator of the study. “Over the years, neonatal intensive care has significantly improved the survival of preterm infants. Fifty years ago, only 5-10% of the smallest babies survived. Today, the corresponding survival rate is much higher at 80%. Several factors, such as mechanical ventilation and pharmaceuticals like surfactants, have significantly contributed to this positive development. With our study data, I expect that IBP-9414 could be the next major improvement targeting the gut, as it is now established that the product increases the survival rate of premature infants. I believe the extraordinary and unexpected large effect on survival is even more important than potential improvements in NEC and SFT. We are extremely grateful for all the excellent work done by our employees and the medical teams in approximately 100 hospitals involved in the study and special thank you to all families who have allowed us to include their infants in the study," says IBT’s CEO, Staffan Strömberg. “Because mortality is considerably lower in the active group, we have decided to pursue our endeavors to register IBP-9414 as a drug. IBT’s financial situation is such that we have sufficient resources to continue our development work. IBT's cash position was SEK 272 million at the end of the second quarter. I am confident our competent staff led by Staffan Strömberg will spare no effort to register the product as a pharmaceutical thereby helping many premature infants in the future,” says Peter Rothschild, IBT’s chairman. This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-30 18:38 CEST.

Infant Bacterial Therapeutics AB (IBT) announces today that it has been granted a Notice of Allowance from the US Patent and Trademark Office (USPTO), meaning that IBT’s patent application has been approved. The patent pertains to the drug candidate IBP-9414, which has been developed by IBT for the prevention of Necrotizing Enterocolitis (NEC) and to improve the nutritional intake and development of premature infants. The invention encompasses a unique method of activating freeze-dried bacteria. The patent reinforces the existing intellectual property protection for IBT’s drug candidate IBP-9414. IBT has been granted orphan drug status in both the USA and the EU. Furthermore, IBP-9414 is a biologic medicine which further strengthens protection through data exclusivity in the USA and EU. The plan is to launch IBP-9414 on the US market as soon as market authorization is obtained. The phase III clinical study was completed in July 2024, and the study results are expected this quarter. CEO Staffan Strömberg comments, “The intellectual property protection for IBP-9414 was already strong before this US patent was approved, as the project had already been granted Orphan Drug Status and is a biologic. The US market is the largest and most important. Being able to strengthen IP protection and additionally extend its duration is great news.” This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-15 16:44 CEST.

Verdict could impact hundreds of additional lawsuits filed against Abbott and Enfamil formula maker Reckitt Benckiser ST. LOUIS, July 26, 2024 /PRNewswire/ -- A closely watched necrotizing enterocolitis (NEC) baby formula bellwether trial culminated in a $495 million judgment Friday against Abbott Laboratories, a verdict that could affect many other lawsuits awaiting litigation in state and federal courts throughout the U.S. Continue Reading The case in the St. Louis trial, Gill v. Abbott Laboratories, No. 2322-CC01251, began July 9 before Judge Michael Noble in the 22nd Judicial Circuit Court of Missouri. The plaintiff brought the claim on behalf of her minor child, who developed NEC after being given Similac and/or Enfamil cow's milk-based products following her premature birth. The infant was forced to undergo extensive surgery and has continued to suffer long-term health consequences. A closely watched NEC baby formula trial culminated in a $495 million judgment against Abbott Laboratories. Post this The jury awarded the Gill family $400 million in punitive damages and $95 million in compensatory damages. The plaintiff and her child were represented by the law firms of Stranch, Jennings & Garvey PLLC (SJ&G) and TorHoerman Law. "The jury followed the evidence and made the right decision," says Hon. John (Jack) Garvey, founding member of SJ&G and co-lead counsel for the lawsuit. "I consider it a great honor to have brought some level of justice to the family." The lawsuit asserted that, "despite scientific consensus that defendants' cow's milk-based products present a dire threat to the health and development of preterm infants, defendants have made no changes to their products or the products' packaging, guidelines, instructions, or warnings. Instead, defendants have continued to sell their unreasonably dangerous products to unsuspecting parents and healthcare providers, generating huge profits as a result." The lawsuit also claimed the defendants breached their duty through misrepresentations made to consumers, physicians and medical staff in their advertising and promotional materials and interactions, and that Abbott's acts, omissions and/or representations showed a deliberate and flagrant disregard for the safety of others. "This is the sort of litigation that our firm takes pride in — where you need to commit massive resources to take on the most powerful bad actors," says J. Gerard Stranch IV, founding and managing member of SJ&G. In addition to Jack Garvey, SJ&G's trial team included Founding Member Mike Stewart and Member Janna Maples, along with associate attorneys Colleen Garvey, Ellen A. Thomas and Caleb Harbison. Hundreds of lawsuits still pending allege that cow's milk-based baby formula products can cause NEC, a life-threatening illness that can affect premature infants. In addition, the lawsuits claim that manufacturers of these products failed to warn of the higher risk of NEC in infants who were given their products versus infants who received breast milk or human milk-derived formula. Gill v. Abbott Laboratories marked the first NEC case brought against Abbott and was the second trial alleging that cow's milk-based baby formula given to premature infants can cause NEC. In the earlier case, Watson vs. Mead Johnson, an Illinois jury awarded $60 million to a plaintiff whose child died from NEC. For additional information about SJ&G, visit . About Stranch, Jennings & Garvey, PLLC: With practice experience dating back decades, Stranch, Jennings & Garvey, PLLC has a longstanding history of prominence in complex litigation. Our attorneys specialize in class action, mass tort, ERISA trust funds, labor unions, bank fees, data breaches, wage and hour disputes, worker adjustment and retraining notification, product liability, personal injury and trucking accidents. Known for their integrity, experience and dedication, our attorneys are members of numerous state and national associations, committees and boards. SOURCE Stranch, Jennings & Garvey