Simtuzumab

Galecto's tough clinical journey developing an idiopathic pulmonary fibrosis treatment has ended in a phase 2 failure. Galecto’s bumpy clinical ride developing an inhaled treatment for idiopathic pulmonary fibrosis came to a screeching halt after midstage data showed that the drug was ineffective.  The company is now discontinuing work on the candidate, a small-molecule inhibitor of galectin-3 dubbed GB0139, and funneling resources toward a treatment for liver cirrhosis with a new trial on the horizon, according to an announcement Tuesday.  GB0139 failed to hit the phase 2 trial’s primary endpoint, a change from baseline in the rate of decline in forced vital capacity (FVC)—a measure of air exhaled from the lungs—compared to placebo. In fact, the average reduction in FVC was 316.6 ml among patients treated with a 3-mg daily dose of Galecto’s candidate for a year, compared to a less pronounced drop of 127.5 ml for those given placebo, meaning treated patients fared much worse. Galecto also said that levels of the galectin-3 protein rose in both arms, indicating a lack of target engagement for the treatment. The trial enrolled 173 patients who had not previously received standard-of-care IPF treatments—Genentech’s Esbriet or Boehringer Ingelheim’s Ofev.  The results and subsequent decision to call it quits mark an abrupt end to a tough clinical journey. In March 2021, the data safety and monitoring board recommended that the company ax the 10-mg treatment arm after an “imbalance” in serious side effects was cropping up. That left the 3-mg arm as the only option moving forward, with recruitment restarting a few months later. Still, the safety profile now disclosed failed to differentiate, with 7.8% of treated patients reporting serious side effects compared to 1.4% for the placebo arm, with one severe case in the treatment arm attributable to the drug.  “We clearly saw more side effects in the sort of IPF infection exacerbation with the drug and that's where we're searching for the explanation for what's happening,” CEO Hans Schambye, M.D., Ph.D., told Fierce Biotech in an interview.  Adverse events leading to death were similar in both the treatment and placebo arms, Galecto reported, with Schambye explaining that mortality was slightly lower among treated patients. None of the deaths in the treatment arm were attributable to the study drug.  Galecto’s attention now turns to another galectin-3 inhibitor called GB1211 and its development as a treatment for liver cirrhosis. The company just wrapped a type C meeting with the FDA and is gearing up for a placebo-controlled phase 2 trial in patients with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis, set to start in early 2024. Schambye told Fierce that he believes that, given the bleak prognosis for patients who develop cirrhosis, the market potential is high even as other biotechs show promise at treating NASH earlier in the disease progression.  “It's very different from the NASH compounds that are focused mainly on reducing the inflammation and reducing the fat storage in the liver cells and trying to sort of prevent the disease from happening,” the CEO said. “We’re in those places where this has already happened.”  What’s been made clear is that Galecto will need to raise additional funds to see GB1211 through the upcoming study and beyond. Schambye said investors were wary while the focus was the IPF med, given the difficulty treating the lung condition. But with liver disease as the focus, the CEO thinks he can corral fresh interest and fresh capital. GB1211 is also being developed as a cancer treatment, alongside a LOXL2 inhibitor called GB2064, opening the door for partnership opportunities. “I firmly believe that biotech companies should go where the data tells them to go and then pursue the opportunities that present themselves,” Schambye added. 

BOSTON, April 28, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended March 31, 2023. “Galecto continued to make strong progress with its clinical programs in the first quarter of 2023 and remains on target for several significant milestones this year. We reported exciting preliminary data from our clinical trials that are evaluating our oral galectin-3 inhibitor GB1211 plus atezolizumab for the first-line treatment of non-small cell lung cancer and our LOXL2 inhibitor GB2064 for the treatment of myelofibrosis, which further deepen our confidence in the potential of our pipeline,” said Hans Schambye, President and Chief Executive Officer of Galecto. “The Galecto team is delivering on development plans for our novel therapies, and we continue to expect top-line results from our Phase 2b GALACTIC-1 trial of our lead product GB0139 in idiopathic pulmonary fibrosis this August.” First Quarter and Other Recent Highlights Reported partial response in two patients in the open-label portion (Part A) of the Phase 1b/2a GALLANT-1 trial evaluating GB1211 in combination with atezolizumab for the treatment of non-small cell lung cancer (NSCLC). A partial response is defined by RECIST criteria to be shrinkage of at least 30% of the tumor. One of these patients has been treated with GB1211 200 mg twice daily for 23 weeks, while the other has been treated with GB1211 100 mg twice daily for 14 weeks, and both patients continue to receive active treatment in the trial. Recruitment in Part A of this trial is currently ongoing. Reported data from three additional evaluable myelofibrosis patients in the Phase 2a MYLOX-1 trial with GB2064 for the treatment of myelofibrosis that showed one patient experienced a 1-grade reduction in reticulin fibrosis at nine months and, following an initial increase of collagen fibrosis score of 1 grade at six months, experienced a 1-grade reduction of collagen fibrosis at nine months. In the third quarter of 2022, Galecto announced that four of five evaluable myelofibrosis patients in an intermediate assessment experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow, an improvement suggesting that GB2064 could impact the progression of the disease and potentially be disease modifying. Because the trial has exceeded the pre-defined target of a ≥ 1 grade reduction in collagen fibrosis in at least three out of 16 evaluable patients, Galecto believes that MYLOX-1 has reached the dual goal of confirming LOXL2 as an attractive fibrosis target and demonstrating that GB2064 has clinically meaningful antifibrotic activity. Accordingly, Galecto has determined to stop enrolling additional patients in the trial and will continue following the remaining patients. Presented two posters at the American Association for Cancer Research (AACR) Annual Meeting 2023 showing anti-cancer activity in both our galectin-1 specific inhibitor and our dual acting galectin-1/3 inhibitor compounds, which could provide potential new cancer therapies. Expected Upcoming Milestones Top-line results from Phase 2b GALACTIC-1 trial (IPF) with GB0139 in August 2023 Top-line results from Phase 2a MYLOX-1 trial (myelofibrosis) with GB2064 in 2H 2023 Interim safety data from Phase 2a GALLANT-1 trial (NSCLC) with GB1211 in 2H 2023 Initiation of Phase 2 investigator-sponsored GB1211 oncology trial (melanoma and HNSCC) by Providence Cancer Institute in 2H 2023 First Quarter 2023 Financial Highlights Cash, cash equivalents, and investments as of March 31, 2023 were approximately $57.2 million. The company anticipates that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital requirements into the second half of 2024. Research and development expenses were $10.4 million for the period ended March 31, 2023, compared to $13.2 million for the period ended March 31, 2022. The decrease of $2.8 million was due primarily to lower clinical spending based on timing of clinical trial activities. General and administrative expenses were $3.1 million for the period ended March 31, 2023, compared to $3.7 million for the period ended March 31, 2022. The decrease of $0.6 million was primarily related to decreased insurance costs and other various general and administrative costs. Net loss attributable to common stockholders for the period ended March 31, 2023 was $13.0 million or $(0.51) per basic and diluted share, compared with $16.9 million, or $(0.67) per basic and diluted share, for the prior year period. About Galecto Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a recently completed Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in combination with atezolizumab (Tecentriq®) in a separate Phase 2a trial for the treatment of NSCLC. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s ability to make progress across its clinical pipeline of asset and Galecto’s expectation that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements into the second half 2024. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 9, 2023. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.