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Global • 2026-10-31, 13:47 GMT • ~1 min read

UK approves trial for PX578, a potential treatment for rare POLG disease

برطانیہ نے نایاب پولگ بیماری کے ممکنہ علاج پی ایکس 578 کے ٹرائل کی منظوری دے دی

ब्रिटेन ने दुर्लभ पीओएलजी रोग के संभावित इलाज पीएक्स578 के परीक्षण को मंज़ूरी दी

UK approves trial for PX578, a potential treatment for rare POLG disease

Key points

اہم نکات

मुख्य बातें

  • The UK medicines regulator has cleared a clinical trial for PX578, a molecule being developed as a potential treatment for POLG-mediated mitochondrial disease, for which there are currently no approved disease-modifying therapies.
  • PX578, developed by Pretzel Therapeutics, is a small molecule activator designed to restore mitochondrial function and increase mitochondrial DNA levels.
  • It will be evaluated in the randomised, double-blind, placebo-controlled phase 2 POLARIS study, which the company plans to start by the end of 2026.
  • برطانیہ کے ادویات کے ادارے نے پی ایکس 578 کے کلینیکل ٹرائل کی منظوری دے دی ہے، جو پولگ سے متعلق مائٹوکونڈریل بیماری کے ممکنہ علاج کے طور پر تیار کیا جا رہا ہے، جس کے لیے ابھی کوئی منظور شدہ علاج موجود نہیں۔ پریٹزل تھراپیوٹکس کا تیار کردہ پی ایکس 578 ایک چھوٹا مالیکیول ہے جو مائٹوکونڈریا کی کارکردگی بحال کرنے اور ان کے ڈی این اے کی سطح بڑھانے کے لیے بنایا گیا ہے۔ اسے فیز 2 پولارس اسٹڈی میں جانچا جائے گا، جسے کمپنی 2026 کے آخر تک شروع کرنے کا ارادہ رکھتی ہے۔ امریکی ادارے ایف ڈی اے نے اگست میں اس دوا کی درخواست منظور کی تھی اور ستمبر میں اسے فاسٹ ٹریک کا درجہ دیا تھا۔
  • ब्रिटेन की दवा नियामक संस्था ने पीएक्स578 के क्लिनिकल परीक्षण को मंज़ूरी दे दी है, जो पीओएलजी से जुड़ी माइटोकॉन्ड्रियल बीमारी के संभावित इलाज के रूप में विकसित किया जा रहा है, जिसके लिए अभी कोई अनुमोदित इलाज मौजूद नहीं है। प्रेट्ज़ेल थेराप्यूटिक्स का तैयार किया पीएक्स578 एक छोटा अणु है जो माइटोकॉन्ड्रिया के काम को बहाल करने और उनके डीएनए के स्तर को बढ़ाने के लिए बनाया गया है। इसे फ़ेज़ 2 पोलारिस अध्ययन में जाँचा जाएगा, जिसे कंपनी 2026 के अंत तक शुरू करने का इरादा रखती है। अमेरिकी संस्था एफ़डीए ने अगस्त में इस दवा के आवेदन को मंज़ूरी दी थी और सितंबर में इसे फ़ास्ट-ट्रैक का दर्जा दिया था।

The UK medicines regulator has cleared a clinical trial for PX578, a molecule being developed as a potential treatment for POLG-mediated mitochondrial disease, for which there are currently no approved disease-modifying therapies. PX578, developed by Pretzel Therapeutics, is a small molecule activator designed to restore mitochondrial function and increase mitochondrial DNA levels. It will be evaluated in the randomised, double-blind, placebo-controlled phase 2 POLARIS study, which the company plans to start by the end of 2026. The US Food and Drug Administration cleared the drug's investigational application in August and granted it fast-track status in September.

برطانیہ کے ادویات کے ادارے نے پی ایکس 578 کے کلینیکل ٹرائل کی منظوری دے دی ہے، جو پولگ سے متعلق مائٹوکونڈریل بیماری کے ممکنہ علاج کے طور پر تیار کیا جا رہا ہے، جس کے لیے ابھی کوئی منظور شدہ علاج موجود نہیں۔ پریٹزل تھراپیوٹکس کا تیار کردہ پی ایکس 578 ایک چھوٹا مالیکیول ہے جو مائٹوکونڈریا کی کارکردگی بحال کرنے اور ان کے ڈی این اے کی سطح بڑھانے کے لیے بنایا گیا ہے۔ اسے فیز 2 پولارس اسٹڈی میں جانچا جائے گا، جسے کمپنی 2026 کے آخر تک شروع کرنے کا ارادہ رکھتی ہے۔ امریکی ادارے ایف ڈی اے نے اگست میں اس دوا کی درخواست منظور کی تھی اور ستمبر میں اسے فاسٹ ٹریک کا درجہ دیا تھا۔

ब्रिटेन की दवा नियामक संस्था ने पीएक्स578 के क्लिनिकल परीक्षण को मंज़ूरी दे दी है, जो पीओएलजी से जुड़ी माइटोकॉन्ड्रियल बीमारी के संभावित इलाज के रूप में विकसित किया जा रहा है, जिसके लिए अभी कोई अनुमोदित इलाज मौजूद नहीं है। प्रेट्ज़ेल थेराप्यूटिक्स का तैयार किया पीएक्स578 एक छोटा अणु है जो माइटोकॉन्ड्रिया के काम को बहाल करने और उनके डीएनए के स्तर को बढ़ाने के लिए बनाया गया है। इसे फ़ेज़ 2 पोलारिस अध्ययन में जाँचा जाएगा, जिसे कंपनी 2026 के अंत तक शुरू करने का इरादा रखती है। अमेरिकी संस्था एफ़डीए ने अगस्त में इस दवा के आवेदन को मंज़ूरी दी थी और सितंबर में इसे फ़ास्ट-ट्रैक का दर्जा दिया था।

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