Allay Therapeutics

Today we announced another important milestone in the development of our lead investigational product candidate ATX101. The U.S. Food & Drug Administration has accepted our investigational new drug application, clearing the way for us to initiate a pivotal Phase 2B clinical trial of ATX101 for the treatment of post-surgical pain following total knee replacement surgery. This clinical trial builds on a strong foundation of clinical data from prior exploratory dose-ranging studies that demonstrated ATX101’s potential to transform the pain management paradigm. We are excited for the opportunity to further evaluate ATX101 and plan to enroll 200 trial participants at U.S. sites.     We are committed to pioneering ultra-sustained, non-opioid-based analgesic products that aid patient recovery while reducing the costs of these surgeries for patients, physicians and payors alike. Today’s milestone is another key marker on the path to a new drug application to be filed with the FDA.   More in today’s press release: https://lnkd.in/eguJ7ViK #clincaltrial #painmanagement #TKA #analgesic #bupivacaine #nonopiod #postsurgicalrecovery #drugdelivery #kneereplacement #orthopedics #orthopedicsurgery

It was a big week at Allay’s San Jose headquarters, with colleagues from our Singapore office in town for strategic planning, connecting with teammates, and a chance for everyone to work on their golf game. The whole team pitched in to assemble 750 STEM kits in support of Scientific Adventures for Girls. Once again, many thanks to our friends at Life Science Cares Bay Area for helping organize a fun way to bring science to life for children in our community. 

We’re excited to announce clinical study results supporting our lead investigational product ATX101, which we believe has potential to transform post-surgical pain management and recuperation for patients and their physicians. In a Phase 2B study in patients undergoing total knee replacement surgery, ATX101 achieved sustained post-surgical pain relief for up to four weeks and outperformed a standard of care active comparator on durability of effect, use of opioids to support pain relief and the potential for patients to return to day-to-day activities earlier.   Allay is committed to pioneering ultra-sustained, non-opioid-based analgesic products that aid patient recovery while reducing the costs of these surgeries for patients, physicians and payors alike. These results provide clear guidance for the design of a pivotal clinical study as we move towards registration.   We thank our investigators, staff and participating patients for helping us deliver this important clinical milestone.   More in today’s press release: https://lnkd.in/ef9c9SYA   #painmanagement #TKA #analgesic #bupivacaine #nonopioid #postsurgicalrecovery #drugdelivery #kneereplacement #orthopedics #orthopedicsurgery

The highly collaborative and entrepreneurial spirit of #Singapore has been an important element of the Allay story from day one. We were excited to be part of recent coverage from BioCentury Inc. examining the momentum and rapid growth of Singapore’s #biotech sector. Check out the full article: https://lnkd.in/eshGv7uA

We’re excited to announce a license agreement providing Maruishi Pharmaceutical with exclusive rights to develop and commercial our lead candidate ATX101 in Japan. Read more: https://lnkd.in/eqYM3kzM ATX101 is a non-opioid, bupivacaine-based drug product designed to provide weeks of post-surgical pain relief. We believe this partnership provides a natural fit to help accelerate the development of ATX101 and potentially deliver better pain management solutions for patients in Japan. 

We had a blast joining together in our San Jose HQ to assemble slime kits to help inspire curiosity and hands-on STEM learning for young future scientists in our area. Thanks to Life Science Cares Bay Area for helping to organize another great way to support science education for our valued community partners Spark Bay Area and Breakthrough San Francisco.  

What a week for Allay in Singapore! It was fantastic to bring members of the U.S. and Singapore teams together, including our Board of Directors, to get to know each other better and talk about the exciting path forward for the company. As always, we are inspired by the vibrancy of this very special place and tremendously grateful that we have the opportunity to transform post-surgical pain management. 

We were thrilled to join the ClavystBio team and distinguished guests for this wonderful event, and to have members of our US and Singapore-based teams and Board of Directors with us to witness firsthand the exciting progress that Clavyst has made in accelerating collaboration and progress for ventures like ours.

We were thrilled recently to gather our U.S.-based colleagues for a fun-filled late-summer celebration. We stepped outside the labs and conference rooms of our newly completed North San Jose facility to enjoy delicious Hawaiian barbecue bites, cool beverages, colorful and tasty shaved ice, and even an island-themed bouncy house that the children in attendance really enjoyed. This was a great opportunity for team bonding and reflection and a nice respite from the team’s everyday hard work to change the paradigm of pain management.