Riding the Fast Track to Pharma Success
By Tim Stobierski
May 2024
Developing new drugs and medical treatments is a costly endeavor — both in terms of time and funding. According to Dr. Ritu Lal, CEO and Co-Founder of GEn1E Lifesciences, it can take up to 10 years and hundreds of millions of dollars just to get from early drug discovery to the start of phase 2 (first-in-patient) clinical trials.
That’s what makes GEn1E’s story so impressive. In just two and a half years and with just $7 million in seed capital, the company — which uses AI and machine learning to identify and develop novel therapies for inflammatory diseases — was able to bring its lead drug, GEn-1124, to phase 2 patient clinical trials.
The drug is designed to treat acute respiratory disease syndrome (ARDS), a lung condition that can originate from a number of causes including flu, smoke inhalation and COVID-19 infection. The FDA granted GEn-1124 a fast-track designation. Fewer than 15 programs each year receive that distinction, out of hundreds that apply.
“This designation really speaks to the massively unmet need, and GEn1E’s strong data,” says Ritu.
“The mortality rate for patients with ARDS is greater than 40%,” she notes. “And the average cost of treatment is more than $100,000 per patient. With no currently FDA-approved therapies, we’re excited about the promise that GEn-1124 offers.”
It can take up to 10 years and hundreds of millions of dollars to get to phase 2 clinical trials. GEn1E did it in 2½ years with just $7 million.
GEn1E has partnered with the Biomedical Advanced Research and Development Authority to evaluate precision medicine endotyping approaches, and to test the drug’s effectiveness in different patient populations. Despite this early success, GEn1E isn’t resting on its laurels. The company is happy to announce that it’s in the process of scaling its portfolio of novel assets by advancing two new therapies through its pipeline.
The second drug is an oral package to treat chronic inflammatory disease in at-home settings (as compared to GEn-1124, which must be administered by IV in a hospital). The third drug being developed is a novel therapy for use in oncology, though “it’s a little bit too early to share details about that program right now,” Ritu says.
The company’s goal is to take both of these programs to the IND-enabling stage in the next 12 months, with less than $5 million spent per indication.
“Up until now, GEn1E has always been thought of primarily as an ARDS company — a great ARDS company,” says Ritu. “By advancing these new assets targeting different diseases, that narrative is evolving. Soon, we’ll be known as what we’ve really been all along: a precision medicine company for multiple inflammatory and rare diseases, developing therapies with unprecedented efficiency.”