Elgan Hopes Perseverance With Enteral Insulin For Preterm Infants Will Pay Off

The product improved GI function and reduced related complications, including life-threatening events, in a Phase III study despite an initial futility analysis. An exec stayed confident, acquired the product and plans to initiate a confirmatory trial.

baby foot
Elgan is developing a unique insulin formula for premature babies • Source: Alamy

Elgan Pharma is moving forward with a confirmatory Phase III study of ELGN-GI, an enteral insulin formulation for the treatment of intestinal malabsorption in preterm infants, a condition that can lead to other complications and life-threatening events. The company announced plans on 2 March to initiate a confirmatory Phase III trial studying ELGN-GI in premature infants, following the publication of positive Phase III trial results in JAMA Pediatrics on 28 February.

Company founder and CEO Miki Olshansky believes ELGN-GI could be a multibillion-dollar commercial opportunity given how common premature births are,...

More from Clinical Trials

Takeda Prepares Ground For Oveporexton In Narcolepsy

 

The drugmaker announced positive results from two Phase III trials for the drug in narcolepsy type 1 that analysts said bode well for the OX2R agonist class as a whole.

Leo Lands Another Big Pharma Pact With Boehringer Spevigo Deal

 
• By 

Paying €90m upfront for rights to generalized pustular psoriasis drug.

Pipeline Watch: Ten Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Capricor Gets Complete Response For DMD Cell Therapy

 
• By 

Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.

More from R&D

Phase III Success For AstraZeneca’s $5bn Hypertension Hope Baxdrostat

 

Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.

Leo Lands Another Big Pharma Pact With Boehringer Spevigo Deal

 
• By 

Paying €90m upfront for rights to generalized pustular psoriasis drug.

Pipeline Watch: Ten Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.