ASX Health Stocks: Tissue Repair and Radiopharm jump double digits after US FDA meetings
Health & Biotech
Health & Biotech
Wound healing specialist Tissue Repair (ASX:TRP) surged 14% this morning after saying the US FDA has cleared the company to progress to a Phase 3 trial for its lead drug candidate, TR-987.
This comes after a meeting with the FDA, which was held following the conclusion of the Phase 2 trial.
During the meeting, the company reached broad agreement with the FDA on the core components of the proposed Phase 3 trial protocol.
TRP will now submit this protocol for final review by FDA and clearance for patient enrolment, with plans to commence enrolment before end of year. US and Australian sites have already been canvassed with some 15 sites approached.
TRP co-founder Tony Charara said is was a big milestone for TRP to enter Phase 3.
“TRP now has a genuine shot at delivering the first drug to be approved for treatment of chronic venous leg ulcers in almost two decades,” he said,
“This is a debilitating condition with significant unmet needs. Achieving an FDA-approved new drug label is a very valuable prize”.
Radiopharm Theranostics (ASX:RAD) also jumped 11.5% after completing a positive pre-Investigational New Drug (IND) meeting with the US FDA for F18-pivalate (RAD 101).
RAD 101 is a proprietary imaging agent composed of F18 radioisotope and pivalate – a small molecule that targets fatty acid synthetase.
This development will allow Radiopharm to move towards its IND application for the company’s late stage clinical trial.
Based on positive guidance received from the FDA, the company will file an IND application to initiate a multi-centre trial for imaging brain metastasis during the Q3 of 2023, and anticipates having the first patient dosed by the end of the year.
“Being so close to late stage development is highly exciting for us and for the medical community,” said Riccardo Canevari, CEO of Radiopharm.
Avecho Biotechnology (ASX:AVE) announced that the US Patent Office has allowed its new patent application in regards to the manufacturing process for TPM.
TPM (or Tocopheryl Phosphate Mixture) is Avecho’s proprietary drug delivery system derived from Vitamin E which can enhance the absorption and solubility of drugs and nutrients.
It’s the core technology underpinning all of Avecho’s product development activities.
The granting of a US patent is significant, as it will provide Avecho with monopoly rights to Avecho’s TPM manufacturing process until about December 2037 or later.
The development follows the recent patent grants to the manufacturing process in India, Japan, Mexico, Russia, and Singapore.
“With this new patent, allowed in the largest pharmaceutical market in the world, we have ensured our ability to protect our technology and products that contain the technology, well into the future,” said Avecho CEO, Dr Paul Gavin.
Amplia Therapeutics (ASX:ATX) climbed 11% after announcing that new pre-clinical data have shown the efficacy of its investigational FAK inhibitor, AMP945, in pancreatic cancer when used in combination with FOLFIRINOX treatment.
FOLFIRINOX is currently a widely-used treatment in many major markets around the world including the US.
In light of this data, the company has filed a patent to cover the use of FAK inhibitors, and particularly AMP945, in combination with FOLFIRINOX and related treatment regimes.