Zelasudil

The clinical stage biotech made the announcement about its oral, selective, rho associated coiled-coil containing protein kinase (ROCK2) today (August 21). The drug is currently in a phase 2a clinical study for IPF with topline data expected in the first quarter of next year (2024). The FDA can grant ODD to support the development and evaluation of new treatments to prevent, diagnose or treat a rare disease or condition that affects fewer than 200,000 in the US. IPF - unmet need for patients The designation provides Redx with various development and commercial incentives, including market exclusivity, in order to address this unmet need for patients suffering from IPF. Dr Jane Robertson, chief medical officer, Redx Pharma said: “We are delighted that the FDA has recognised the potential of zelasudil for the treatment of IPF and granted Orphan Drug Designation. “Selectively targeting ROCK2 is an exciting, novel approach which could provide a new treatment option for patients with IPF, and with potential applications in other interstitial lung diseases and cancer-associated fibrosis. “We are encouraged by both the strength of our preclinical package as well as the clinical results to date and we look forward to reporting Phase 2a topline data in the first quarter of next year.” Zelasudil is an orally available, highly selective small molecule inhibitor that targets ROCK2 which sits at a nodal point in a cell signalling pathway, believed to be central to fibrosis. ROCK2 selectivity is important to avoid systemic hypotension, a serious cardiovascular side effect which has been seen in product candidates that systemically inhibit both ROCK1 and ROCK2. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Potential to treat several fibrotic diseases As a selective ROCK2 inhibitor zelasudil, has the potential to treat several fibrotic diseases and has demonstrated robust anti-fibrotic effects in a range of industry-standard in vivo preclinical models, results of which were presented at the International Colloquium on Lung and Airway Fibrosis (ICLAF) and the Antifibrotic Drug Development Summit (AFDD) last year (2022). Redx is evaluating zelasudil initially as a treatment for IPF, a severe and life-threatening chronic lung condition with limited treatment options. IPF is a lung disease that causes scarring and reduction in lung function slowly over time. Primarly older adults mainly aged 50 and over get the disease which involves irreversible and variable scarring, stiffening, and thickening of the lung tissues leading to sufferers experiencing shortness of breath and lack of oxygen absorption. There are more than 170,000 people suffering from IPF according to Redx’s research with a further 53,000 people diagnosed every year in the US, five EU countries and Japan. The company says patients diagnosed with IPF have an estimated life expectancy of 3 to 5 years. There is no known cure and current treatment only slows progression of the disease.

We’ll be keeping an eye out for everything from the Big Pharma bolt-ons and blockbusters to the reverse mergers and biotech-on-biotech buyouts. Acquisitions are back, biotech. After a stagnant year with pharma sitting on a heap of cash, the fruits of in-person business development meetings are beginning to ripen. And so today, Fierce Biotech launches the M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. We’ll be keeping an eye out for everything from the Big Pharma bolt-ons and blockbusters to the reverse mergers and biotech-on-biotech buyouts. Here’s hoping the remaining three quarters of 2023 are filled with exciting deals that can pull the biotech industry out of its cloud to brighter days. https://omny.fm/shows/the-top-line/february-10-2023/embed   May XinThera Date: May 9 Buyer: Gilead Sciences Price: Undisclosed Gilead is picking up PARP1 and MK2 inhibitor specialist XinThera for an undisclosed sum, adding a few early-stage prospects to its pipeline. The goal is to find a match for breast cancer med Trodelvy to take on AstraZeneca’s Lynparza. Story   Iveric Bio Date: May 1 Buyer: Astellas Pharma  Price: $5.9 billion Astellas is paying a cool $5.9 billion to enter an eye disease niche with the acquisition of Iveric Bio. The biotech is awaiting an FDA decision for the approval of avacincaptad pegol, a complement C5 protein inhibitor that reduced the rate of geographic atrophy progression in a phase 3 clinical trial. Story April Bellus Health Date: April 18 Buyer: GSK Price: $2 billion GSK has bought out Bellus Health for its phase 3 chronic cough treatment camlipixant, a rival to Merck & Co.'s stalled candidate gefapixant. The Big Pharma believes that, even if camlipixant arrives on the market years after Merck does, a multibillion-dollar opportunity awaits. Story   Satsuma Pharmaceutical Date: April 17 Buyer: Shin Nippon Biomedical Laboratories Price: $0.91 per share, estimated $30 million* Satsuma Pharma was in need of a helping hand to move its migraine spray forward, and the company behind the nasal spray tech stepped up with a 91 cents per share offer. Story  * Deal value calculated by share price multipled by outstanding shares.    Prometheus Biosciences Date: April 17 Buyer: Merck & Co. Price: $10.8 billion Prometheus created a lot of buzz with midstage data for bowel disease candidate PRA023 late last year. Merck emerged victorious with an offer of $10.8 billion, but it wasn't the only Big Pharma that tried. Story StrideBio Date: April 5 Buyer: Ginkgo Bioworks Price: Undisclosed Ginkgo is bolstering its gene therapy capabilities with the purchase of AAV gene therapy capsid specialist StrideBio. The goal of the acquisition is to gain the biotech's intellectual property, not to get into drug development. The company's TRX-330 program for arrhythmogenic right ventricular cardiomyopathy will be sold off. Story March Diffusion Pharmaceuticals Date: March 30 Buyer: EIP Pharma Price: N/A EIP needed help to bring an ex-Vertex molecule into phase 2, and Diffusion Pharma proved to be the lifeline. The two companies decided to merge to create one publicly listed company to complete a clinical trial in dementia with Lewy bodies. Story   Jounce Therapeutics Date: March 27 Buyer: Concentra Biosciences Price: $1.85 per share, estimated $97.4 million* Jounce and Redx planned to ride out the biotech markets together in a reverse merger. Jounce was expected to contribute at least $130 million to the combined group to fund Redx's ROCK2 inhibitor RXC007. But months later, Jounce bounced and instead took a deal from Concentra Biosciences. Story * Deal value calculated by share price multipled by outstanding shares.  Dynacure Date: March 2 Buyer: Flamingo Therapeutics Price: Undisclosed Flamingo Therapeutics picked up Dynacure in a deal that will see the combined companies work together to develop RNA-targeted oncology therapies. Dynacure CEO Stéphane van Rooijen, M.D., will lead the combination with Flamingo CEO Michael Garrett at his wing as chief operating officer. Story February Adamis Pharmaceuticals Date: Feb. 28 Buyer: DMK Pharmaceuticals Price: Undisclosed Another biotech searching for help after a rough go in the clinic, Adamis accepted a merger with neurology-focused DMK Pharmaceuticals. Story   Infinity Pharmaceuticals Date: Feb. 23 Buyer: MEI Pharma  Target:  Price: N/A MEI Pharma and Infinity Pharma will join forces in a biotech-to-biotech merger that will see a newly named company rise from the ashes. Cambridge, Massachusetts-based Infinity will become a wholly owned subsidiary of MEI, whose shareholders will own approximately 58% of the company. Story VBL Therapeutics Date: Feb. 23 Buyer: Notable Labs Price: N/A 2022 didn't go well for VBL Therapeutics, and so the immune- and inflammatory-disease-focused biotech will merge with cancer-focused platform company Notable. Story   Erytech Pharma Date: Feb. 15 Buyer: Pherecydes  Price: N/A A new company focused on extended phage therapies will emerge from the combination of Erytech Pharma and French biotech Pherecydes. Story   Immunorizon Date: Feb. 2 Buyer: Purple Biotech Price: Up to $100 million Privately held Immunorizon will come under the wing of Purple, which focuses on tumor immune evasion and drug resistance. Purple has two lead assets in the pipeline: NT219 and CM24 for solid tumors and pancreatic ductal adenocarcinoma, respectively. Story January Concert Pharmaceuticals Date: Jan. 19 Buyer: Sun Pharmaceuticals Price: $576 million Sun Pharma has plunked down a cool $576 million to go up against Eli Lilly's approved alopecia treatment with Concert's JAK inhibitor. Story   Flame Biosciences Date: Jan. 17 Buyer: Leap Therapeutics Price: $86 million Leap Therapeutics hopped over to pick up Flame Biosciences for $86 million on a day busy with deals, adding another candidate to its pipeline. Story   4SR Biosciences Date: Jan. 17 Buyer: hC Bioscience Price: Undisclosed In a merger of equals, 4SR Bio's sequencing technology will be brought over to hC Bio to identify more potential therapeutics. Story Angion Biomedica Date: Jan. 17 Buyer: Elicio Therapeutics Price: N/A Elicio Therapeutics caught a ticket to the public markets via a reverse merger with Angion Biomedica to continue pushing a cancer vaccine into phase 2 trials. Story   CinCor Pharma Date: Jan. 9 Buyer: AstraZeneca Price: $1.8 billion AstraZeneca saw a good time to strike as CinCor Pharma's share price dropped throughout the winter of 2022. The U.K. pharma offered up $1.8 billion to bring on the blood-pressure-focused biotech, which is working toward a phase 3 study for aldosterone synthase inhibitor baxdrostat in uncontrolled hypertension. Story Blacksmith Medicines Date: Jan. 3 Buyer: Forge Therapeutics Price: N/A Blacksmith Medicines went back home in this transaction that saw the metalloenzymes-focused biotech spin right back into Forge Therapeutics. Blacksmith spun out of Forge in 2021. An entirely new entity, which the companies dubbed "the new Blacksmith," will emerge from the transaction to focus on oncology and infections. Story