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Odyssey Therapeutics Announces OD-001 Clinical Trial Results

Odyssey Therapeutics announced results from the completed induction period of its Phase 2a clinical trial evaluating OD-001, an oral, selective RIPK2 scaffolding inhibitor, in patients with moderate-to-severe ulcerative colitis, or UC. The results were presented earlier today at United European Gastroenterology, or UEG, Week in Barcelona, Spain, and will be discussed alongside additional analyses during a conference call and webcast to be hosted by Odyssey. The completed OD-001 induction analysis comprises all 56 efficacy-evaluable patients. The high correlation between treatment outcomes and changes in inflammatory biomarkers, mucosal transcriptomic signatures, and histologic disease activity strengthens the previously established clinical proof of concept for OD-001 and provides biological evidence consistent with RIPK2 scaffolding inhibition. Combined with Phase 1 pharmacology data, these findings support 20 mg twice daily, or BID, as the projected lowest maximally efficacious dose. OD-001 met the trial's primary endpoint of change from baseline in modified Mayo score at the end of induction at Week 12. At this time point, clinical remission, clinical response, and symptomatic remission were 27%, 61%, and 49%, respectively, in the pooled 20 mg BID group and 20%, 40%, and 27%, respectively, at 10 mg BID. In patients treated with 20 mg BID, fecal calprotectin trended lower, hsCRP and circulating neutrophils were significantly decreased, and serum albumin significantly increased-all changes consistent with reduced intestinal and systemic inflammation. The reduction in neutrophils, a RIPK2-expressing cell type implicated in IBD pathogenesis, provides additional mechanistic support. Symptomatic remission at 20 mg BID reached 21% at Week 2, increasing throughout the induction period with no plateau observed through Week 12. After 12 weeks of treatment with OD-001, clinical remission at 20 mg BID was 29% in advanced therapy-naive and 23% in advanced therapy-experienced patients. Clinical remission at Week 12 for patients taking OD-001 at 20 mg BID was 16% in patients with a Mayo Endoscopic Score of 3. Exploratory analyses of paired colonic biopsies from baseline and Week 12 showed reductions in RIPK2-responsive and downstream inflammatory gene signatures, including IL-23, TNF/NF-B, TL1A, AP-1 and T-cell-associated pathways, supporting the proposed mechanism of action. Reductions in fibrosis-associated signatures and increased expression of genes linked to epithelial homeostasis and mucosal healing aligned with clinical outcomes. Exploratory patient-level comparisons with published datasets of approved therapies suggest OD-001 modulates RIPK2-associated pathways beyond general mucosal improvement achieved with other agents, supporting a differentiated mechanism of action and pharmacodynamic profile. OD-001 was generally well tolerated during the 12-week induction period, with no serious adverse events, serious infections, treatment-related discontinuations, or treatment-emergent liver function abnormalities. As previously reported, three adverse events in the 20 mg BID group were considered drug-related. One Grade 3 anemia event in the 10 mg BID group occurred in a patient with pre-existing anemia, was considered unrelated to treatment, and resolved with iron supplementation without discontinuing OD-001. Odyssey plans to advance OD-001 into a randomized, placebo-controlled Phase 2b monotherapy trial and a randomized, active-controlled Phase 2a trial evaluating OD-001 plus vedolizumab versus vedolizumab plus placebo. Both studies will be double-blind, with topline induction results expected in the second half of 2027.

Evotec Enters Strategic R&D Collaboration with Odyssey Therapeutics

Evotec (EVO) announced that it has entered a strategic R&D collaboration with Odyssey Therapeutics (ODTX) to discover potential new treatments in autoimmune and inflammatory diseases. Under the agreement, Odyssey will leverage Evotec's integrated data-driven discovery platform, advanced screening capabilities and AI-enabled data science technologies to discover and validate differentiated small molecule drug candidates across multiple high-value disease targets. By combining high-throughput experimentation with machine learning-driven analysis, the collaboration is designed to accelerate the identification of validated hit series and enable the rapid progression of therapeutic programs with the potential to transform the standard of care. The collaboration combines Odyssey's deep expertise in autoimmune and inflammatory disease biology with Evotec's discovery infrastructure and proprietary compound libraries. By bringing together complementary scientific and technological strengths, the companies aim to accelerate early-stage research and efficiently generate and advance new medicines.

Mobia Medical, Odyssey Therapeutics and Others Go Public This Week

New listings continued to roll out this week, with Mobia Medical, Odyssey Therapeutics, Suja Life, and HawkEye 360 all making their public market debuts.LATEST IPOS AND DIRECT LISTINGS:Mobia Medicalopened on May 8 at $14. The company priced 10M shares at $15.00. The deal priced at the midpoint of the $14.00-$16.00 range. Mobia is a commercial-stage medical device company that says it is "redefining stroke recovery for survivors living with life-altering motor impairments."Odyssey Therapeuticsopened on May 8 at $20. The company priced 15.5M shares at $18.00. The deal size was increased to 15.5M shares from 13.2M and priced at the top end of the $16.00-$18.00 range. Odyssey is a clinical-stage biopharmaceutical company that says it is "seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that are designed to precisely target disease pathology."Suja Lifeopened on May 7 at $18.00. The company priced 8.89M shares at $21.00. The deal priced at the low-end of the $21.00-$24.00 range. Suja Life is a maker of organic, cold-pressed juices, wellness shots, and "better-for-you" sodas.HawkEye 360opened on May 7 at $33.80. The company priced 16M shares at $26.00. The deal priced at the high-end of the $24.00-$26.00 range. HawkEye 360 delivers space-based collection, proprietary signal processing, and AI-powered analytics to the U.S. Government and allied partners.RECENT SPAC IPOS:Starlink AI Acquisitionopened on May 8 at $10.00. The blank check company intends to conduct a search for target businesses without being limited to a particular industry.Shreya Acquisition Groupopened on May 7 at $10.00. The blank check company intends to focus on companies engaged in the health and wellness, hospitality, media and entertainment, shipping infrastructure and waterways tourism sectors.Vernal Capital Acquisitionopened on May 6 at $10. D. Boral Capital is acting as sole book-running manager of the offering.PERFORMANCE:Prices as of 11:00 am ET on Monday, May 11 -Mobia Medical – down over 2% at $11.50;Odyssey Therapeutics – up almost 4% at $17;Suja Life – down 1% at $17.66;HawkEye 360 – down about 3% at $32.46.RECENT IPOS TO WATCH:Madison Airand Arxisare already seeing coverage roll out, while AEVEX, Alamar Biosciencesand Kailera Therapeuticsare among stocks that could see new coverage this week as the quiet periods for banks that underwrote the companies' IPOs expire.UPCOMING IPOS:Upcoming IPO and direct listings expected include Inspire Brands, Csquare, Tarsier Pharma, and Quantinuum.Clickto see upcoming IPO calendar on TipRanks.Inspire Brandsannounced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission relating to the proposed initial public offering of its common stock. Inspire Brands expects to use the net proceeds of the proposed offering to repay outstanding indebtedness under its existing term loan facility and pay offering fees and expenses. Inspire is a multi-brand restaurant company whose portfolio includes the Dunkin' Donuts, Arby's, Buffalo Wild Wings, Sonic Drive-In, Jimmy John's and Baskin-Robbins chains.Csquarefiled confidentially for a U.S. initial public offering, a signal that more data center companies are lining up to sell shares for the first time over the coming year, Bloomberg's Bailey Lipschultz. The provider of colocation and data center services announced on Friday that it had submitted a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission. The Brookfield Infrastructure Partners-backed company joins a rush of new listings as the companies building out the backbone to support AI's energy needs seek to raise funds, the author notes.Tarsier Pharma Ltd.filed for an initial public offering of its ordinary shares and applied to list its ordinary shares on the NYSE American under the symbol "TARX". The prospectus stated, "Tarsier Pharma is developing TRS01 and TRS02, novel product candidates based on dazdotuftide, a new molecule with a new mechanism of action for uveitis and uveitic glaucoma. We are attempting to address a significant, underserved market opportunity and have engaged closely with the FDA on our clinical development strategy, including a Special Protocol Assessment agreement for our planned pivotal trial... Although we are still early in this journey, I believe we have the technology, the team, the discipline, and the persistence required to build an enduring company."Honeywellannounced thatQuantinuumhas publicly filed a registration statement on Form S-1 with the U.S. SEC relating to a proposed initial public offering of shares of its Class A common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Quantinuum intends to list its Class A common stock on the Nasdaq Global Select Market under the ticker symbol "QNT." J.P. Morgan and Morgan Stanley are acting as joint lead active book-running managers for the proposed offering. Jefferies and Evercore ISI are also acting as active book-running managers.OTHER IPO NEWS:SpaceX's IPO filing indicates governance provisions that would give Elon Musk near-total control through supervoting shares and other restrictive measures, significantly limiting typical shareholder rights and avenues for investor oversight, Reuters' Anirban Sen, Ross Kerber and Suzanne McGee."Opening Day" is The Fly's recurring series of stories on the latest initial public offerings, their performance, and upcoming IPOs.