Erythromelalgia

DELRAY BEACH, FL / ACCESS Newswire / April 23, 2025 / Adolore BioTherapeutics (“Adolore” or the “Company”) is developing intracellularly-delivered neuromodulators that naturally reduce neuronal excitability to restore balance to the PNS/CNS to treat the underlying root cause of serious neurological disorders, including chronic pain and announced today Mr. Roelof Rongen, the Company’s CEO, is a presenter at the Festival of Biologics USA 2025 meeting, “FOB”, on April 24, 2025 in San Diego, Ca. Adolore is delighted to present and highlight Adolore’s innovative CA8* therapeutics in development (Kv7 activating carbonic anhydrase-like neuromodulating peptides, CA8* variants). Neuromodulation using gene therapy is an exciting new area that has widespread applications in treating serious undertreated neurological disorders including chronic pain. There is a paucity of safe, efficacious non-opioid analgesic treatments for chronic pain, creating a large and very urgent unmet medical need given the ongoing opioid crisis. Adolore currently has two therapeutic programs in development, including peripheral neuropathy caused by erythromelalgia, which is an orphan disease, (ADB-101), and Adolore’s lead program (ADB-102) for chronic pain caused by moderate-to-severe knee osteoarthritis. Based on compelling preclinical data, the Company is progressing these programs toward Investigational New Drug, (“IND”), filings and first-in-human clinical studies. These CA8* therapies were licensed in 2023 by Adolore from the University of Miami, Miami, FL. The rdHSV intracellular biotherapeutics delivery technology was licensed by Adolore from the University of Pittsburgh, in 2023. The Company’s neuromodulation development program for the treatment of chronic pain due to moderate-to-severe knee osteoarthritis is supported by the NIH/NINDS HEAL UH3 Award to the University of Miami that funds all formal pre-clinical GLP/GMP/GCP development work through a first-in-human clinical study in patients, which is expected to commence in 2026. About Adolore BioTherapeutics, Inc. Adolore BioTherapeutics, Inc., is focused on developing novel intracellularly delivered treatments for chronic pain, drug-resistant epilepsy, seizure disorders, neurodegeneration and neurotrauma/neuroprotection, e.g., hearing loss. The Company’s chronic pain treatment platform comprises two highly innovative technologies: our CA8* analgesic peptides, and our cutting-edge, disease-free, nontoxic rdHSV vector-based intracellular biotherapeutics delivery technology. Our best-in-class programs are long-acting, localized gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs). The Company’s two current CA8* DMAP programs are in preclinical development for treating patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and patients suffering with chronic pain due to moderate-to-severe knee osteoarthritis, which affects a large number of patients that are often treated with opioids due to the lack of good alternatives, thus contributing to the ongoing opioid crisis. For more information, visit adolore.com. Forward Looking Statements To the extent this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “will,” “should,” “may,” “plan,” “intend,” “assume” and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Investor Relations Contact Paul Barone(215)622-4542pbarone@adolore.com SOURCE: Adolore Biotherapeutics, Inc. View the original press release on ACCESS Newswire

iStock, ALLVISIONN AlgoTherapeutix blames a “strong placebo effect” for the mid-stage failure for its pain gel ATX01, but the company still believes in the promise of its candidate as Vertex Pharmaceuticals’ first-in-class drug Journavx opens up the non-opioid space. Just over a week after the landmark approval of Vertex Pharmaceuticals’ non-opioid pain drug Journavx, AlgoTherapeutix has suffered a setback in the space, with its investigational topical analgesic therapy ATX01 failing to significantly ease pain in patients suffering from chemotherapy-induced peripheral neuropathy. The Paris-based biotech said Tuesday that ATX01 showed “encouraging” efficacy signals, especially when given at the higher, 15% concentration dose. However, several study sites documented what CEO Stéphane Thiroloix in a statement called a “strong placebo effect,” which in turn prevented ATX01’s benefit from hitting statistical significance. Posthoc analyses of the study’s data showed that in trial centers with low placebo effect, 15% ATX01 elicited significantly better pain relief than placebo. Despite the lack of a significant response, Thiroloix called Tuesday’s readout “a significant step forward” for ATX01, pointing to promising signals of efficacy, such as the 1.6-point pain improvement, as measured by the Numerical Pain Rating Scale. ATX01 was also superior to placebo in terms of key secondary endpoints in posthoc analyses. Designed to be applied topically, ATX01 is a proprietary formulation of amitriptyline , an antidepressant that has been approved by the FDA in a tablet form to treat depression. AlgoTx’s version, however, leverages the non-systemic application of amitriptyline, which potentially dampens or blocks pain signaling locally, focusing on nerve fibers in the skin. Though it did not specifically spell out its future plans for ATX01, AlgoTx in its news release on Tuesday seemed to still believe in the promise of its candidate in chemotherapy-induced peripheral neuropathy. The company “sees a strong rationale to further explore the development of ATX01 15%,” AlgoTx noted, adding that it can look at other trial designs to minimize or even eliminate the placebo effect, such as enrichment/withdrawal strategies or a placebo run-in period. “There is the potential to design a new study, with additional mitigation strategies in place, to evaluate ATX01’s efficacy . . . without ambiguity,” Thiroloix said. BioSpace has reached out to AlgoTx for more clarity on ATX01’s path forward and will update this story accordingly. AlgoTx was previously testing ATX01 for erythromelalgia—a rare vascular condition that affects the extremities and causes intense pain—but according to the biotech’s website , a readout last year returned underwhelming data, forcing the biotech to discontinue the asset’s development in this indication. AlgoTx is also running early studies for ATX01 in painful diabetic peripheral neuropathy, COVID-induced neuropathy and phantom limb pain. AlgoTx’s mid-stage stumble on Tuesday comes after Vertex earlier this month won the FDA’s approval for Journavx, an inhibitor of the NaV1.8 voltage-gated sodium channel that marks the first new mechanism for analgesia in over 20 years—and potentially offering the U.S. a way out of its opioid crisis. According to data from the National Institute on Drug Abuse, nearly 74,000 people died from an overdose of synthetic opioids in 2022. Meanwhile, the Centers for Disease Control and Prevention estimated that the cost of opioid use disorder and related fatalities reached over $1 trillion in 2017. And Journavx may be only the beginning for this new class of pain medicines as several other biotechs seek to follow in Vertex’s footsteps. Lexicon, Algiax, Xgene and Tris Pharma are among those with non-opioid candidates in mid- to late-stage trials, for example. Meanwhile, newcomer Latigo Bio, which launched in February 2024 with $135 million in starting funds to advance its own oral NaV1.8 blocker LTG-001 and is now launching a Phase II trial , said in Friday SEC filing stated that it is now targeting up to $150 million in new funding.

FREEHOLD, N.J., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Channel Therapeutics Corporation, (“Channel” or the “Company”), (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, is providing a statement regarding Vertex Pharmaceutical’s recently announced Phase 2 data of Suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy. “We are encouraged to see that the product will advance to Phase 3 trials in painful lumbosacral radiculopathy, pending discussions with regulators,” said Eric Lang, Channel’s Chief Medical Officer. “While both NaV1.7 and NaV1.8 are voltage-gated sodium channels mainly expressed in sensory neurons, there are important differences in their roles in pain transmission. Research indicates that an over expression of NaV1.8 leads to moderate pain whereas an overexpression of NaV1.7 leads to debilitating pain morbidities, and we believe that NaV1.7 inhibition may be a more potent therapy for pain treatment.” Characteristics of Selective NaV1.7 Inhibition NaV1.7 is a well-studied drug target with strong genetic validation — studies of inheritable pain disorders demonstrate that the spectrum of NaV1.7 activity validates the importance of this target. Lack of NaV1.7 activity leads to the inability to sense pain, whereas NaV1.7 gain of function leads to severe pain. Modulation of NaV1.7, therefore, should be an effective mechanism for decreasing pain. “Channel Therapeutics has chosen a three-pronged approach for our NaV1.7 molecule to demonstrate the utility of this target. We are utilizing an oral NaV1.7 inhibitor for the potential treatment of neuropathic pain starting with Idiopathic Small Fiber neuropathy and Erythromelalgia, a novel eye drop formulation of a NaV1.7 inhibitor to treat eye pain and a novel slow-release depot formulation NaV1.7 inhibitor for post-surgical nerve blocks,” stated Frank Knuettel II, Chief Executive Officer of Channel. “The important differences between NaV1.7 and NaV1.8 not only informs but also differentiates Channel Therapeutics’ approaches to clinical development of the Company’s selective sodium channel blockers CC8464, CT2000 and CT3000. We are very encouraged by the recent data that we have seen from our ongoing programs, including the results from our in vivo nerve block results published earlier this week. As such, we look forward to the upcoming studies and data readouts in 2025 which will serve as critical milestones for which to further substantiate the merits of Channel’s clinical development plan,” Mr. Knuettel concluded. About Channel Channel Therapeutics Corporation is a clinical-stage biotechnology company focused on developing and commercializing novel, non-opioid, non-addictive therapeutics to alleviate pain. The Company’s initial clinical focus is to selectively target the sodium ion-channel known as NaV1.7 for the treatment of various types of chronic pain, acute and chronic eye pain and post-surgical nerve blocks. For company updates and to learn more about Channel, visit www.channeltherapeutics.com or follow us on social media. Forward-Looking Statements This press release contains forward-looking statements regarding the Company’s current expectations. These forward-looking statements include, without limitation, references to the Company’s expectations regarding (i) the Company’s belief that nerve blocks with its NaV1.7 inhibitors may be viable options for the treatment of acute and postoperative pain, (ii) the Company’s belief the Company’s NaV1.7 inhibitor has the potential to improve on existing postoperative therapeutic options while opening the door for success with the Company’s other programs, (iii) the Company’s belief that the NaV1.7 inhibitor may offer a better option for post-surgical physical therapy as compared to bupivacaine, (iv) the Company’s belief that investors should feel encouraged that the Company has a strong development path towards successfully launching drugs with considerable market opportunities, and (iv) the timing of expected results on the Company’s eye drops for the treatment of various types of eye pain. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to there being no guarantee that the trading price of the Company’s Common Stock will be indicative of the Company’s value or that the Company’s Common Stock will become an attractive investment in the future. These and other risks and uncertainties are described more fully in in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law. Channel Media and Investor Inquiries:Mike MoyerManaging Director, LifeSci Advisors, LLCmmoyer@lifesciadvisors.com