SAN DIEGO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies, today announced the completion of its Phase 1 clinical trial evaluating its lead product candidate, CG001419, a potential first-in-class, oral, pan-TRK protein degrader, which is part of a new class of pain signaling channel modulators for the treatment of pain.
Cullgen’s Phase 1 study (NCT06636500) was a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose/food-effect (with or without food) and multiple-ascending-dose trial that evaluated the safety, tolerability and pharmacokinetic characteristics of CG001419 in 78 healthy volunteers. The study was conducted in Australia after receiving ethics committee approval in early 2025. Results from the study showed that all doses were well-tolerated with no drug-related serious adverse events observed.
“We are very pleased with the positive outcome of this Phase 1 study. CG001419 is an important program as it could provide a new, non-opioid, non-NSAID analgesic therapy option for patients suffering from acute and chronic pain,” commented Ying Luo, Ph.D., Chief Executive Officer of Cullgen. “Given the favorable outcome of this study, we plan to submit an IND for CG001419 in early 2026, and, pending FDA allowance of the IND, initiate a Phase 2 study in acute pain in bunionectomy patients in the United States. In addition to studying CG001419 in pain applications, it is also being studied in a separate Phase 1 clinical trial in China in patients with solid tumors.”
Pipeline Update
In addition to CG001419, Cullgen continues the advancement of CG009301, a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, as well as progressing its pipeline of pre-clinical targeted protein degraders and degrader-antibody conjugates.
Cullgen recently advanced a new cell cycle protein degrader product candidate into preclinical studies and is preparing to initiate IND-enabling studies. Also, in the near future, Cullgen anticipates advancing an additional product candidate into IND-enabling studies for the treatment of inflammatory diseases.
About Cullgen Inc.
Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies designed to improve the lives of patients suffering from critical conditions such as pain, or cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.
Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (“TRK”) degrader that recently completed a Phase 1 trial for the treatment of acute post-operative pain. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs including next-generation degrader-antibody conjugates.
For more information, please visit www.cullgen.com.
Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. These forward-looking statements include express or implied statements relating to: the therapeutic potential and utility, efficacy and clinical benefits of CG001419, including for the treatment of pain and solid tumors; the risk/benefit profile of CG001419, including the potential of CG001419 to reduce the risk of addiction associated with other pharmaceutical therapies for the treatment of pain; expectations regarding Cullgen’s research and development efforts, including timing of Cullgen’s anticipated IND filing with the FDA and initiation of Phase 2 trials for CG001419; Cullgen’s expectations regarding the advancement of product candidates into IND-enabling studies; and Cullgen’s expectations, hopes, beliefs, intentions and strategies; and other statements that are not historical fact. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to: risks associated with the Cullgen’s ability to manage expenses and unanticipated spending and costs that could reduce Cullgen’s cash resources; risks related to the Cullgen’s ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the Cullgen to obtain sufficient additional capital to continue to advance its product candidates, its preclinical programs and its clinical trials; the ability of the Cullgen to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; Cullgen’s ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; Cullgen’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; Cullgen’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and Cullgen’s ability to obtain necessary approvals from the U.S. Food and Drug Administration or other regulatory authorities; changes to clinical trial designs and regulatory pathways; changes in expected or existing competition; and legislative, regulatory, political and economic developments. A discussion of these and other factors, including risks and uncertainties with respect to Cullgen, is set forth in Pulmatrix Inc.’s (“Pulmatrix”) definitive proxy statement/prospectus filed with the Securities and Exchange Commission and declared effective on May 9, 2025, as may be supplemented or amended by Pulmatrix’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as risk factors associated with companies, such as Cullgen, that operate in the biopharma industry. Should one or more of these risks or uncertainties materialize, or, should any of Cullgen’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Cullgen does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Pulmatrix or Cullgen.
CONTACTS:
Cullgen Inc.
Thomas Eastling, CFO
Investors
Chuck Padala
Managing Director, LifeSci Advisors
chuck@lifesciadvisors.com
