| Indication | Inflammatory bowel disease |
| Drug | Prifemilast |
| Mechanism of Action | PDE4 inhibitor |
| Company | cAMPfield Therapeutics |
| Trial Phase | Phase 2b, Phase 2 |
| Category | Corporate & Strategic |
| Sub Category | Licensing Agreement |
| Funding Amount | $180 million |
| Deal Type | In-licensing, Exclusive global development and commercialization rights |
| Licensed Territory | Global (outside Greater China) |
| Licensor | Newsoara Biopharma |
| Previous Licensor | vTv Therapeutics |
| Previous Deal Value | up to $135 million |
| Patient Population Size (Previous Trials) | More than 700 |
| Investors | Frazier Life Sciences, Deep Track Capital, Forbion, Abingworth, Venrock, Longitude Capital, Novo Holdings, RA Capital |
| Related Indication (Previous Trial) | Plaque psoriasis |
| Dosage Frequency | Once-daily |
cAMPfield Launches with $180M to Advance Prifemilast for IBD
cAMPfield Therapeutics has launched with $180 million in Series A funding to advance prifemilast, an oral PDE4 inhibitor, for inflammatory bowel disease (IBD). The company secured exclusive global development and commercialization rights to prifemilast, licensed from Newsoara Biopharma, outside of Greater China. This funding will support the initiation of global Phase 2b trials for moderate-to-severe ulcerative colitis and Phase 2 studies for Crohn’s disease. Prifemilast, previously studied in over 700 participants, has demonstrated a tolerable safety profile and efficacy in a Phase 3 trial for plaque psoriasis, an immune-mediated inflammatory disease with overlapping characteristics with IBD. cAMPfield aims to establish prifemilast as a new standard of care, offering a convenient once-daily oral therapy.
- cAMPfield Therapeutics has successfully raised $180 million in Series A funding, led by Frazier Life Sciences, with significant contributions from Deep Track Capital, Forbion, Abingworth, Venrock, Longitude Capital, Novo Holdings, and RA Capital. This substantial investment is earmarked for the development of prifemilast, an oral PDE4 inhibitor. The company has secured exclusive global development and commercialization rights for prifemilast outside of Greater China through an in-licensing agreement with Newsoara Biopharma, which had previously acquired global rights from vTv Therapeutics in a deal valued up to $135 million.
- Prifemilast (HPP737) is characterized as a selective PDE4B inhibitor, targeting the subtype most strongly associated with anti-inflammatory effects while minimizing PDE4D inhibition, which can cause dose-limiting adverse effects. Clinical studies involving over 700 participants have shown a tolerable safety profile, with treatment discontinuation rates comparable to placebo. Furthermore, prifemilast has demonstrated efficacy in a Newsoara-conducted Phase 3 trial for plaque psoriasis, an immune-mediated inflammatory disease sharing characteristics with IBD, providing a strong foundation for its potential in IBD.
- cAMPfield is poised to advance prifemilast into global mid-stage clinical trials, specifically launching a Phase 2b trial for moderate-to-severe ulcerative colitis and a Phase 2 study for Crohn’s disease. The company's leadership, comprising seasoned industry veterans, believes prifemilast's potential for efficacy, tolerability, and convenient once-daily oral administration could address significant unmet needs in IBD. The goal is to establish prifemilast as a preferred treatment option, offering robust disease control for patients who currently struggle with existing therapies due to insufficient remission or safety concerns.
Navigating the PDE4 Inhibitor Landscape for IBD
The PDE4 inhibitor class encompasses several investigational and approved agents being evaluated across inflammatory indications, with prifemilast representing one of the more recent entrants. While the dermatological pipeline has historically dominated PDE4 inhibitor development, a number of compounds have progressed through clinical evaluation with varying intervention designs.
| Drug | Development Stage | Indication(s) | Intervention Model |
|---|---|---|---|
| Apremilast | Approved + ongoing trials | Psoriasis, psoriatic arthritis, palmoplantar pustulosis (PPP) | Placebo-controlled phase II (AD); single-arm, open-label (MOSAIC study, psoriatic arthritis); prospective comparative (methotrexate vs. methotrexate + apremilast) |
| Roflumilast | Approved (COPD); phase II (dermatology) | Atopic dermatitis, COPD | Placebo-controlled phase II (failed to meet primary endpoint in AD) |
| LEO 29102 (Compound 20) | Phase II | Atopic dermatitis | Phase II efficacy study (topical soft-drug formulation; demonstrated clinically relevant efficacy) |
| ME3183 | Phase I completed (2022) | Psoriasis, atopic dermatitis, inflammatory diseases | Single and multiple ascending dose studies (126 healthy adults; SADs up to 25 mg; MADs up to 10 mg twice daily) |
| LY2775240 | Investigational | Psoriasis, inflammatory disorders | Dose-ranging PK/PD study (20 mg dose; 50–80% TNFα inhibition sustained over 24 hours) |
| Crisaborole | Approved (USA, 2016) | Mild-to-moderate atopic dermatitis | Topical formulation; approved via placebo-controlled registration trials |
| Ibudilast | Phase II | Multiple sclerosis | Multicentre, double-blind, placebo-controlled phase II (297 patients; 30 mg vs. 60 mg vs. placebo; 12-month duration across 19 centres) |
Addressing Persistent Challenges in Inflammatory Bowel Disease Treatment
Despite meaningful therapeutic advances over the past two decades, IBD management continues to be constrained by a convergence of pharmacological, biological, and patient-level challenges. The absence of fully targeted therapies for ulcerative colitis, combined with the immunosuppressive burden inherent to the most effective agents, underscores a persistent gap between clinical need and available options. These limitations span conventional and biologic treatment paradigms alike, affecting both treatment durability and patient quality of life.
Toxicity and systemic adverse effects of conventional therapies: Anti-inflammatories, glucocorticoids, and immunosuppressants remain foundational to IBD management but are significantly limited by systemic toxicity during long-term use. Corticosteroids in particular are ineffective for maintaining remission in ulcerative colitis, and prolonged use carries well-documented serious side effects — a concern of particular clinical weight in a predominantly young patient population where improving the benefit-to-risk ratio is critical.
Primary nonresponse and secondary loss of response to biologics: A significant proportion of patients fail to achieve or sustain response to biologic agents and small-molecule therapies. Loss of response to agents such as infliximab and adalimumab is frequently attributable to the development of anti-drug antibodies (ADAb), with genetic factors — including HLA-DQA1*05 alleles — identified as consistent risk factors for immunogenicity. Drug resistance further compounds the challenge in ulcerative colitis, where current pharmacological options including aminosalicylates, biologics, and immunomodulators are all affected.
Disease heterogeneity and absence of fully targeted therapies: IBD presents with marked inter-patient variability in phenotype, disease course, and treatment response, making uniform management strategies insufficient. No fully targeted therapies currently exist for ulcerative colitis, and the clinical significance of biomarkers remains difficult to discern at the individual level. The challenge of identifying patients requiring early intensive intervention — and predicting which therapeutic class they will respond to — remains largely unresolved.
Underutilization of prognostic tools in clinical trial design: Despite meaningful progress in developing prognostic and stratification tools, clinical trials have not routinely incorporated these approaches into their study design. This gap limits the ability to enrich trial populations based on predicted response, and hinders the broader translation of precision medicine frameworks into routine IBD care.
Extraintestinal manifestations and unmet patient-level needs: Many patients present with heterogeneous and difficult-to-manage extraintestinal manifestations that current treatment algorithms inadequately address. Beyond physical symptoms and side effects, patients report significant psychological burden — including anxiety surrounding the need for surgery or ostomy, uncertainty about medication onset and long-term effects, and a pronounced need for psychological support and improved communication with healthcare providers.
The Evolving IBD Treatment Landscape: Where Prifemilast Fits
Over the past five years, the IBD treatment landscape has undergone a fundamental structural shift — moving from a largely anti-TNF-centric paradigm toward a diversified, precision-oriented framework. Three new drug classes have entered or are approaching approval for ulcerative colitis: IL-23 antagonists (risankizumab, mirikizumab, guselkumab), sphingosine-1-phosphate receptor (S1PR) modulators (ozanimod, etrasimod), and selective JAK inhibitors. Real-world sequencing data from 2,948 patients (2014–2021) illustrate this shift in practice: in UC, vedolizumab as first-line advanced therapy demonstrated superior persistence without inadequate response over three years compared to infliximab (p<0.05), while in Crohn's disease, adalimumab, ustekinumab, and vedolizumab all showed superior three-year persistence over infliximab (p<0.001, p<0.001, and p<0.017, respectively). A parallel Scandinavian population-based analysis of 791 patients diagnosed between 1987 and 2016 further confirmed the directional trend: the biologic era (2000–2016) was associated with increased endoscopic monitoring, higher early immunosuppressant and biologic initiation rates, and a measurable decline in colon resection rates compared to the pre-biologic period.
Concurrently, the definition of therapeutic success has been substantially elevated. Treatment targets have evolved from symptom control toward composite endpoints encompassing endoscopic and histologic remission, with the first standardized core outcome set for IBD RCTs established in 2022 through collaboration involving 235 patients and 53 experts. For Crohn's disease, co-primary endpoints now include symptomatic remission and endoscopic response using the Simple Endoscopic Score for CD, with week-12 endoscopic remission independently associated with reduced 52-week disease-related hospitalizations (IRR 0.45; 95% CI 0.22–0.95; p=0.036). In UC, composite endpoints integrating the 9-point Mayo Clinic Score, fecal urgency, and histopathologic indices (Robarts or Geboes) have been formalized. De-escalation data add further nuance: among 64 IBD patients in mucosal healing after ≥2 years of anti-TNF therapy, 57.8% relapsed following biologic cessation (median time to relapse 13.5 months), and the probability of relapse within four years was significantly higher in patients with residual histologic activity at withdrawal (OR 2.72; p<0.001) — underscoring that endoscopic remission alone may be insufficient as a de-escalation criterion.
Looking ahead, the pipeline reflects both the unmet need and the mechanistic expansion underway. Current advanced therapies achieve clinical response in only 30–60% of trial participants, approximately 20% of patients require hospitalization, and 7% undergo colectomy within five years of diagnosis. Over 100 investigational agents are currently in Phase II or III development for moderate-to-severe UC, targeting mechanisms including next-generation JAK and TYK2 inhibitors with enhanced selectivity, novel cell trafficking modulators, TNF-like ligand 1A pathway inhibitors (clinical remission rates exceeding 25% vs. <2% for placebo), and immune checkpoint modulators. Dose optimization data for non-TNFi agents — including α4β7-integrin inhibitors and IL-12/IL-23 inhibitors — indicate that escalation can recapture response in both primary non-response and secondary loss-of-response settings, though therapeutic drug monitoring protocols for these agents remain to be validated. The convergence of gut-selective compounds, biomarker-guided selection, and combination therapy strategies signals a clear paradigm shift toward precision medicine in IBD management.
Prifemilast's IBD Ambition: A High-Stakes Bet on Oral PDE4 Inhibition
The launch of cAMPfield Therapeutics with significant Series A funding to advance prifemilast, an oral PDE4 inhibitor, into Phase 2b/2 trials for inflammatory bowel disease (IBD) marks a bold strategic move. This investment underscores the persistent demand for novel, convenient oral therapies in IBD, a chronic condition where existing treatments, including biologics, often face challenges related to patient compliance with parenteral formulations or insufficient response.
PDE4 inhibitors operate by regulating pro-inflammatory cytokines, a mechanism that has proven effective in other immune-mediated inflammatory diseases. For instance, apremilast, another oral PDE4 inhibitor, has demonstrated sustained efficacy and a favorable safety profile in moderate-to-severe plaque psoriasis and psoriatic arthritis over extended periods. Its real-world use has shown it can replace older oral systemic therapies due to a better safety profile and longer treatment persistence, and it can even be safely co-administered with biologics. This established track record in dermatology provides a strong foundation for prifemilast's potential.
However, the path for PDE4 inhibitors in IBD has historically been challenging. While preclinical studies have shown promise, no PDE4 inhibitor has yet successfully completed a Phase 3 clinical study demonstrating effectiveness in IBD. This suggests that translating efficacy from skin conditions to the complex gastrointestinal inflammation of IBD may present unique hurdles. Furthermore, common adverse events associated with PDE4 inhibitors, such as nausea and diarrhea, though generally mild, have been noted as reasons for discontinuation in real-world settings for other drugs in this class. Managing these side effects will be crucial for patient adherence and long-term success.
The IBD therapeutic landscape is also becoming increasingly crowded with other small molecule drugs, including JAK inhibitors and S1P modulators, which have already shown promising results in advanced clinical trials for both Crohn's disease and ulcerative colitis. For prifemilast to carve out a significant niche, it will need to demonstrate a compelling efficacy-to-safety profile that differentiates it from these emerging competitors. The company's success will hinge on its ability to overcome these historical and competitive challenges, ultimately delivering on the promise of a new, effective oral treatment option for IBD patients.
Frequently Asked Questions
References
- [1] Wittmann M, Helliwell PS. Phosphodiesterase 4 inhibition in the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. Dermatology and therapy. 2013 Jun. 23888251
- [2] Siegels D, Heratizadeh A et al.. Systemic treatments in the management of atopic dermatitis: A systematic review and meta-analysis. Allergy. 2021 Apr. 33074565
- [3] Knezevic Ivanovski T, Perovic MM et al.. Is Deep Remission the Right Time to De-Escalate Biologic Therapy in IBD? A Single-Center Retrospective Study. Biomedicines. 2025 Aug 7. 40868182
- [4] Bots S, Gecse K et al.. Combination Immunosuppression in IBD. Inflammatory bowel diseases. 2018 Feb 15. 29462391
- [5] Srivastava D, Krishna A et al.. A Comparative Study of the Efficacy of Methotrexate versus Methotrexate with Apremilast in Moderate to Severe Chronic Plaque Psoriasis. Indian journal of dermatology. 2023 Jul-Aug. 37822410
- [6] Agnihotri G, Lio PA. Revisiting Therapies for Atopic Dermatitis that Failed Clinical Trials. Clinical drug investigation. 2020 May. 32172523
- [7] Lee SD, Hui DS et al.. Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial. Respirology (Carlton, Vic.). 2011 Nov. 21848706
- [8] Kamel S, Alaty WHA et al.. One-year single-center follow-up study of ustekinumab and vedolizumab use in inflammatory bowel disease Egyptian patients as second-line therapy after anti-TNF failure. Przeglad gastroenterologiczny. 2025. 41473491
- [9] Strande V, Lund C et al.. Clinical course of ulcerative colitis: Frequent use of biologics and low colectomy rate first year after diagnosis-results from the IBSEN III inception cohort. Alimentary pharmacology & therapeutics. 2024 Aug. 38837289
- [10] Panés J, García-Bosch O et al.. WITHDRAWN: Cell therapies for inflammatory bowel disease. Current drug delivery. 2011 Oct 21. 22023203
- [11] Sequier L, Caron B et al.. Treatment sequencing in inflammatory bowel disease: Towards clinical precision medicine. Best practice & research. Clinical gastroenterology. 2025 Aug. 40769618
- [12] Van Assche G. Optimizing the benefit to risk ratio of medical therapy of inflammatory bowel diseases. Verhandelingen - Koninklijke Academie voor Geneeskunde van Belgie. 2008. 19725393
- [13] Rabe KF, Bateman ED et al.. Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet (London, England). 2005 Aug 13-19. 16099292
- [14] Yiu ZZ, Warren RB. Novel Oral Therapies for Psoriasis and Psoriatic Arthritis. American journal of clinical dermatology. 2016 Jun. 26923915
- [15] Abbas A, Di Fonzo DMP et al.. Management of ulcerative colitis: where are we at and where are we heading?. Expert review of gastroenterology & hepatology. 2024 Oct. 39470444
- [16] Stange EF. Current and future aspects of IBD research and treatment: The 2022 perspective. Frontiers in gastroenterology (Lausanne, Switzerland). 2022. 41822078
- [17] Culmsee-Holm FB, Buhl E et al.. Identifying Genetic Factors Influencing the Development of Anti-Drug Antibodies in Inflammatory Bowel Disease: A Scoping Review. Journal of inflammation research. 2025. 41439128
- [18] Pai RK, D'Haens G et al.. Histologic assessments in ulcerative colitis: the evidence behind a new endpoint in clinical trials. Expert review of gastroenterology & hepatology. 2024 Jan-Feb. 38509826
- [19] Vootukuru N, Vasudevan A. Approach to loss of response to advanced therapies in inflammatory bowel disease. World journal of gastroenterology. 2024 Jun 14. 38947290
- [20] Rahman S, Rahman T. Unveiling some FDA-approved drugs as inhibitors of the store-operated Ca(2+) entry pathway. Scientific reports. 2017 Oct 16. 29038464















