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Asia

Nyrada Says Phase 2a Trial of Heart Attack Drug Candidate on Track for 2027 Completion

Nyrada (ASX:NYR) said its phase 2a clinical trial evaluating the safety and preliminary efficacy of Xolatryp in heart attack patients remains on track for completion in 2027, according to a Tuesday filing with the Australian bourse.The trial is designed to assess the safety and preliminary efficacy of the drug candidate in reducing heart tissue damage and improving heart function in patients who are suffering a heart attack.Nyrada said Royal Hobart Hospital has withdrawn from the trial due to local resourcing constraints, but the company has selected Royal Perth Hospital to participate, and two additional sites are nearing activation, per the filing.Nyrada is targeting the submission of an investigational new drug application to the US Food and Drug Administration in the second half of the year.The company's shares rose 2% in recent Tuesday trade.

ASX:NYR
Asia

Nyrada Completes Cardioprotection Pilot Study for Lead Drug Candidate

Nyrada (ASX:NYR) completed a preclinical cardioprotection pilot study that confirmed the feasibility and tolerability of the planned subcutaneous dosing for its Xolatryp lead drug candidate in combination with doxorubicin, according to a Wednesday filing with the Australian bourse.The pilot study aimed to evaluate whether Xolatryp can provide a cardioprotective role in anthracycline chemotherapy, to reduce cardiotoxicity without jeopardizing anti-tumor activity, per the filing.Preliminary biomarker data from the trial showed lower levels of a clinically relevant marker of cardiac injury relative to a control group, the company said.The pilot study was not designed to show statistical significance for an efficacy readout, but it will inform the design of a larger cardiomyopathy study for which results are expected in the third quarter, Nyrada said.The company's shares fell 6% in recent Wednesday trade.

ASX:NYR
Asia

Nyrada Says 7 Million Unlisted Options Due to Expire in June; Shares Fall 3%

Nyrada (ASX:NYR) said a total of about 7 million unlisted options are due to expire on June 29, including 2.9 million with an exercise price of AU$0.40, 2 million at AU$0.60, and 2 million at AU$0.90, according to a Thursday Australian bourse filing.The company's shares fell 3% in recent Thursday trade.

ASX:NYR
Asia

Nyrada Says Rodent Study Shows Drug Candidate's Anti-Tumor Activity, Shares Up 14%

Nyrada (ASX:NYR) said that a rodent study demonstrated that its xolatryp drug candidate exhibits anti-tumor activity both as a monotherapy and in combination with doxorubicin, a first-line chemotherapy drug, according to a Wednesday Australian bourse filing.Xolatryp, an inhibitor of Transient Receptor Potential Canonical (TRPC)-3/6/7 ion channels, was evaluated in a Huh7 cell-line derived rodent xenograft model of liver cancer, a standard preclinical model to assess tumor growth inhibition.Huh7 cells were implanted subcutaneously, and treatment was initiated once the tumors reached 50 cubic millimeters to 75 cubic millimeters, marking day 0. The rodents received either vehicle control, doxorubicin, administered twice weekly, xolatryp, administered intratumorally once daily, or a combination of doxorubicin with xolatryp.The combination of xolatryp with doxorubicin led to the greatest anti-tumor effect, showing a 57% reduction in tumor volume compared with vehicle control at day 14. Xolatryp also demonstrated activity as a monotherapy, with a 32% reduction in tumor volume relative to vehicle control. A 41% reduction was observed with doxorubicin monotherapy..A patent application covering the use of xolatryp as an anti-cancer agent was lodged.The data support further preclinical evaluation of xolatryp across additional tumor types where anthracyclines remain standard-of-care therapy. An additional preclinical cardiomyopathy study is being undertaken to further assess the potential of xolatryp to mitigate doxorubicin-associated cardiac injury and support the development of xolatryp as a differentiated adjunct therapy for use with anthracycline-based chemotherapy.Its shares rose 14% in recent trading on Wednesday.

ASX:NYR
Asia

Nyrada Confirms Activation of First Site in Phase 2a Study of Drug Candidate for Heart Muscle Cell Damage

Nyrada (ASX:NYR) confirmed that the Nepean Hospital in New South Wales was activated as the first site in its Protect-MI phase 2a clinical trial assessing Xolatryp in potentially reducing myocardial injury, or damage to the heart muscle cells, in patients suffering a heart attack, according to a Wednesday Australian bourse filing.The trial's primary endpoint is the safety/tolerability of the drug candidate, the filing said. Several secondary efficacy endpoints are also being evaluated, including cardiac function, extent of cardiac injury, biomarkers such as Troponin I levels, and the incidence of arrhythmias of interest.

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