Wockhardt’s investigational antibiotic shows significant effectiveness in global Phase 3 trials

Wockhardt announced significant advancements with its new antibiotic ZAYNICH (WCK 5222) on Friday, highlighting its unique status as the first new chemical entity (NCE) in the antibiotic domain in five decades. 

An NCE is a new drug compound that includes a novel active ingredient not previously approved by any regulatory agency worldwide. It undergoes extensive testing to assess its safety, efficacy, and unique therapeutic potential.

The antibiotic ZAYNICH, a combination of Zidebactam and Cefepime designed to combat superbugs, which are the toughest resistant pathogens, is currently undergoing global Phase 3 clinical trials. Administered under compassionate use provisions, ZAYNICH has shown significant success, the company said.  “ZAYNICH is an entirely new chemical entity (NCE), a proprietary antibiotic discovered in the last 50 years. We recorded 100% success, saving the lives of all the recipients,” said Dr. Habil Khorakiwala, Founder Chairman of Wockhardt.  

One significant case involved a young cancer patient at the University of California Irvine School of Medicinem, USA. This patient, resistant to other antibiotics, responded positively to ZAYNICH within four weeks, the company said in a statement. “In four weeks after the administration of ZAYNICH, the patient responded and was infection-free, with complete healing of wounds,” said Dr Khorakiwala adding that this success allowed the patient to resume chemotherapy.

Wockhardt anticipates the completion of ZAYNICH’s global Phase 3 clinical trials by FY25, with regulatory approvals and a worldwide launch expected by FY26. “We have decided to market ZAYNICH in India and emerging markets and licence it for the US, Europe, and developed countries to one of the global pharmaceutical companies,” explained Dr Khorakiwala.

Regarding the research and development process, ZAYNICH has received a susceptibility breakpoint of 64 mg/L from the Clinical & Laboratory Standards Institute (CLSI) in the USA, the highest ever granted. This indicates its effectiveness against a wide range of resistant Gram-negative pathogens. “Over the last 100 years, no drug has received such a high breakpoint,” Dr Khorakiwala highlighted.

In terms of market strategy, Wockhardt is conducting a short clinical trial in India and expects to be in the market within a year. These antibiotics are priced around £50,000 for a 10-day treatment in western markets. In India, the company plans to offer it at an 80-85% discount. “In India, there are about 750,000 patients with extreme drug resistance annually. We expect to capture 5-10% of this market in the first year,” Dr Khorakiwala noted.

Globally, Wockhardt plans to market ZAYNICH in emerging markets and out-licence it for developed markets. “We have invested around £500 million over 25 years in this project. In the US, the market potential includes about 500,000 patients, with Europe adding another 700,000. Treatment costs around £15,000 for a 7-10 day course, indicating significant market potential,” Dr Khorakiwala elaborated.

The company will handle business and marketing internally for emerging markets. “We will develop our own business organisation for emerging markets,” Dr Khorakiwala stated.

The impact on antibiotic resistance is promising, with ZAYNICH showing a 100% success rate in 30 patients under compassionate use, all of whom were resistant to other antibiotics, the company said in a statement. “ZAYNICH had a 100% success rate, indicating its potential to save many lives once widely available,” Dr Khorakiwala stated.

The first clinical study will conclude by the end of this year. Wockhardt aims to file for US FDA approval and hopes to launch in the Indian market within a year, Dr Khorakiwala said. Wockhardt is also focusing on developing new antibiotics and diabetic products for emerging markets. Their portfolio includes EMROK and EMROK O, the first India-patented antibiotics in over 30 years, and MIQNAF (WCK 4873), a treatment for community-acquired bacterial pneumonia with a 97% success rate. “Our new product pipeline will ensure significant penetration in the emerging markets, which have very limited players,” Dr Khorakiwala said.