MORF-057

iStock, akinbostanci Ensho Therapeutics CEO Neena Bitritto-Garg, recently named to BioSpace ’s 40 Under 40, proved her mettle managing one of the toughest partnerships out there: the one between Eisai and Biogen that led to new Alzheimer’s drugs Aduhelm and Leqembi. Neena Bitritto-Garg was just 26 years old when she wrote a consequential email to her CEO at Eisai. She believed the team was about to make a big mistake and no one was listening to her. Heading into a key conference where Eisai would reveal to the world a positive study in Alzheimer’s disease—long a clinical wasteland of high-pro —she believed they needed to be more explicit about an imbalance of APOE gene carriers in the successful high dose group of the study. Scientists had determined that people who carry this gene progress faster in their disease than those without it. But regulators had asked Eisai to stop enrolling these patients in the high-dose arm because of an increased risk of amyloid-related imaging abnormalities (ARIA), which can signal bleeding or swelling in the brain. In the lower-dose groups, enrollment continued without adjustment because the risk was lower. Ensho CEO Neena Bitritto-Garg Courtesy Ensho Bitritto-Garg, previously a Wall Street biotech analyst, suggested that they get ahead of this storyline and provide the company’s take on APOE status for the late breaking presentation. She knew that her former colleagues and investors would see right through the focus on the successful high-dose arm and call out the low rate of APOE gene carriers. Bitritto-Garg thought that pulling out a subgroup of APOE gene carriers would help prove the case that the drug had been successful by showing there was no difference between carriers and non-carriers. If the presentation went ahead as planned, she predicted, Biogen’s stock would fall as the company’s fortunes were intrinsically tied to the Alzheimer’s work. She even wrote a fake analyst report, what she would have written if she were on the outside, and shared it with her boss at Eisai. The presentation went forward without including Bitritto-Garg’s subgroup suggestions. Biogen’s shares fell as she’d predicted. She was later put in charge of managing the partnership with Biogen, which encompassed the ill-fated Aduhelm and, of course, the drug that would become Leqembi. “It’s no secret that the relationship between Eisai and Biogen is not spectacular,” Bitritto-Garg said. She attributes the difficult relationship to cultural differences between a Japanese and American company. But according to Bitritto-Garg, her decision to stand up is why, seven years later, Eisai trusted her with a clutch of immunology assets that became her company, Ensho Therapeutics. BioSpace 40 Under 40 BioSpace’s 40 Under 40 honors 40 exemplary biotech and pharma professionals who have distinguished themselves in their companies and their field. All under the age of 40, these young leaders already demonstrate our industry’s values of innovation, impact and commitment to improving outcomes for patients. March 31, 2025 Read More Finding a New Purpose Bitritto-Garg left Eisai around the time Aduhelm was heading for an FDA submission—a regulatory approval that would go on to become among one of the agency’s most controversial in its nearly 120-year history. She remembers the Biogen CEO calling for a meeting with Eisai’s top brass and the team hustling because they thought the partnership was in danger. Instead, Michel Vounatsos announced that Biogen would be seeking approval for the drug. But Bitritto-Garg had already been seeking her next gig. She received an offer to go back to the sell side as an analyst at J.P. Morgan, which she took. From there, she got to watch the Aduhelm drama roll out from the sidelines, and then Leqembi rise as the successor. She got to cover those developments as an analyst, having established herself in the neuro space due to her time at Eisai. Bitritto-Garg always believed that Leqembi could be successful, even as her fellow analysts continued to project extreme caution. “It’s incredibly validating to see the science and all that hard work really manifest into something,” Bitritto-Garg said of Leqembi’s approval. Bitritto-Garg moved on to Citi and later Deutsche Bank in biopharma equity research roles. But then something caught her eye: Morphic Holding revealed data showing that the α4β7 inhibitor MORF-057 significantly reduced disease activity in ulcerative colitis. Analysts and investors were delighted, and the company’s stock climbed. But Bitritto-Garg was skeptical. “I asked a bunch of the investors who are top holders of Morphic, like, what’s so exciting about this? Because I think there’s a signal, but it’s not a very strong signal,” she remembered. “The response I got was, well, there’s not a lot of oral α4β7 [inhibitors]. That could be huge.” But Bitritto-Garg knew who had one: Eisai. “Immunology is not a strong suit for Eisai, so I saw an opportunity,” she told BioSpace . From the Other Side of the Table Bitritto-Garg reached out to her old boss at Eisai to see if the company might be interested in spinning out the asset. She offered to find the funding and build a new inflammatory bowel disease-focused company, to tap into the investor excitement around Morphic. “‘We can unlock a lot more value for Eisai. You can focus on Alzheimer’s, you can focus on oncology,’” Bitritto-Garg remembered arguing. She also recalls a distinct advantage she had in those initial discussions, which took about six months. “It also helped when I was negotiating the license agreement, because I used to negotiate for [Eisai], and now I’m negotiating against them.” She brought up the challenges she’d faced during her time working on the Biogen relationship and pressed that Eisai would need to partner these assets to someone, they might as well choose a person they knew was not only a tough negotiator but a friend. This wouldn’t be a “tumultuous relationship” for them, she said. She ultimately sealed a licensing agreement for Ensho’s lead asset, now known as NSHO-101, as well as a handful of backup programs. Bitritto-Garg launched the company last year with her own capital, funding it through the first six months and the initial hires. She raised a friends and family round next and brought in a handful of executives she knew from her analyst work from Telavant, a Roivant company that had recently been acquired by Roche. Then, Morphic did her another favor. The biotech got acquired by Eli Lilly for $3.2 billion on July 8, 2024—days after Bitritto-Garg had closed the deal with Eisai’s subsidiary for the assets. “This was pure luck,” she said. “That actually resulted in a ton of inbound interest. I actually got, like, three term sheets from investors within days of Morphic being acquired.” The interest was so high that Ensho wasn’t ready to absorb it all. Bitritto-Garg, fresh off the licensing deal win, hadn’t even planned out the company’s next steps yet. Wanting something more concrete to offer investors, the new CEO had to turn away those early offers. “We had barely put together a clinical plan and kind of a fundraising plan, right? We were literally just at the very nascent stages when we got a ton of interest,” she said. Drifting through the next several months without much additional capital, Bitritto-Garg and her team decided to work on the formulation for a few months to develop one pill, once a day dosing, rather than go straight into Phase II with the formulation that had previously undergone some Phase I safety testing. Ensho initially targeted a $225 million raise, which would have funded operations through a Phase IIb study. But by the time that plan was ready and the formulation work underway, Bitritto-Garg said the market had turned, making fundraising more challenging. Ensho has since taken capital from friends and family and some institutional investors, raising a little over $24 million so far. But now, Bitritto-Garg said, the company is on track to take NSHO-101 into studies for ulcerative colitis early next year. That means it’s time to fundraise again, and she’s been working hard to do just that, noting that she expects to sign a term sheet for a series A round “in the next couple of weeks.” Bitritto-Garg added that she has several on her desk but she’s still negotiating the details, as she is want to do. Rumor has it, her legacy of tough negotiation lives on at Eisai, where an unnamed executive framed her fake analyst report and hung it on his wall.

Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, corticosteroid-free clinical and endoscopic remission At four years, nearly all patients who achieved clinical remission at one year had improvements in bowel urgency, one of the most disruptive symptoms for patients INDIANAPOLIS, Oct. 7, 2025 /PRNewswire/ -- New data from Eli Lilly and Company (NYSE: LLY) showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years. The results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%). These data are the final results from the LUCENT-3 Phase 3 open-label extension study and will be presented at United European Gastroenterology (UEG) Week, taking place Oct. 4-7 in Berlin.1 "Helping people with ulcerative colitis achieve long-term comprehensive disease control is a major goal for gastroenterologists, as it has remained out of reach for many patients," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "These long-term findings reinforce mirikizumab as a highly effective biologic for UC management, showing sustained clinical, endoscopic and steroid-free remission over four years, and improvement in bowel urgency, which can present a significant burden on patients' lives." In LUCENT-3, the following results were observed after four years of total treatment among those who achieved clinical remission with Omvoh at one year in the Phase 3 LUCENT-2 study: 78% achieved corticosteroid-free clinical remission 78% sustained long-term clinical remission 81% sustained endoscopic remission, defined as an endoscopic subscore of 0 or 1 (excluding friability) 90% achieved remission on the Inflammatory Bowel Disease Questionnaire (IBDQ) 66% achieved histological-endoscopic mucosal improvement, an important marker of deep inflammation resolution 93% achieved a 3 or more-point reduction on the Urgency Numeric Rating Scale (UNRS)*, and 74% achieved UNRS = 0 or 11 *UNRS is the patient-centric scale of 0-10 that evaluates bowel urgency severity, with 0 being no bowel urgency and 10 being worst possible bowel urgency. These data were also evaluated using a modified non-responder imputation (mNRI), presented in the About the LUCENT Clinical Trial Program section below. These results build upon previously disclosed first-of-their-kind long-term results for Omvoh in both UC and Crohn's disease. The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.1 "With these results, Omvoh continues to set a high standard as the first and only IL-23p19 with evidence of sustained efficacy and consistent safety in ulcerative colitis over four years," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Lilly is shaping the future of IBD care to make life better for patients by redefining what's possible in terms of steroid-free, long-lasting, comprehensive disease control, including durable clinical and endo-histologic remission and relief of disruptive symptoms like bowel urgency." Beyond ongoing UC studies, including in pediatric patients (NCT05784246), Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) (NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials evaluating the concomitant use of mirikizumab with an incretin-based therapy. Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 44 countries around the world. Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work. About the LUCENT Clinical Trial Program Omvoh was studied in two Phase 3 randomized, double-blind and placebo controlled clinical trials that evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. Patients (N=1279) were randomized 3:1 to receive Omvoh 300 mg IV or placebo IV Q4W at Weeks 0, 4, and 8 in the blinded induction study (LUCENT-1). Omvoh responders from LUCENT-1 (N=581) were re-randomized 2:1 to receive Omvoh 200 mg or placebo subcutaneous (SC) Q4W for 40 weeks in the blinded maintenance study (LUCENT-2) (52 weeks of continuous therapy). LUCENT-1 and LUCENT-2 studies included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib). Additionally, 41% of patients in LUCENT-1 had failed at least one biologic, 3% had failed a JAKi and 57% were biologic and JAKi-naïve.2 LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of mirikizumab in patients with UC for an additional three years of treatment (up to four years total). Using a mNRI analysis to handle discontinuation and missing data, response rates among Week 52 mirikizumab remitters for major efficacy endpoints included: corticosteroid-free remission (62%), clinical remission (62%), endoscopic remission (66%), IBDQ remission (73%), histologic-endoscopic mucosal improvement (53%), 3 or more-point reduction on UNRS (75%) and UNRS = 0 or 1 (60%).1 Indications and Usage for Omvoh (mirikizumab-mrkz) (in the United States) Omvoh is an interleukin-23 antagonist indicated for adults with: Moderately to severely active ulcerative colitis Moderately to severely active Crohn's disease Important Safety Information for Omvoh (mirikizumab-mrkz) CONTRAINDICATIONS Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment. Infections Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening. Hepatotoxicity Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Immunizations Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh. ADVERSE REACTIONS Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests. Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information. MR HCP ISI CD APP Click to access provided Prescribing Information and Medication Guide . See Instructions for Use provided with the device. About Omvoh Omvoh (mirikizumab-mkrz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.3 Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References 1 Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025. 2 Sands, B, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024;, izae253, 3 Omvoh. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED