Indus Biotech is a drug discovery company, which was founded in 1997.
The company focuses on identifying and developing a new generation of
efficacious and safe drugs for chronic lifestyle, autoimmune and
degenerative diseases. It uses botanicals as a starting point that
allows the company to significantly reduce drug development cost as
well as time-to-market.
The company's inherent 'Engine' for the
identification of novel molecules allows for a highly risk-mitigated
approach to drug discovery. According to the company, the very core of
its discovery process is based on a technology that facilitates the
isolation and stabilization of individual molecules from botanicals
with the potential pharmacological activity. An additional feature of
this technology is its ability to maintain the structural integrity of
isolated lead molecules and thereby preserving their functionality. The
company has developed a pipeline of new chemical entities (NCEs), which
are ready for commercial transaction and are backed by pre-clinical,
clinical, toxicity and early 'proof-of-concept'
According to the founders of the company - Sunil Bhaskaran
and Rajan Srinivasan – other than the remedy for HIV/AIDS,
the company is developing the botanical drug candidate as influenza A
drug, which shows efficacy in various influenza A strains such as H1N1,
H5N1 and H3N2.
The company has received an Investigational New Drug (IND) application
approval from the US Food and Drug Administration (FDA) for this novel
drug candidate, IND02. With this approval, Indus Biotech has become the
first Indian drug discovery company to have obtained IND approval from
FDA to start human clinical trials for this drug in the US.
Furthermore, the company has also made an IND submission with the Drug
Controller General of India (DCGI), the FDA equivalent of the country,
and is awaiting clearance to start a large-scale study in India.
The company expects that after getting the approval, the clinical
studies for H1N1 would take five to seven months, while for HIV it
would take 18 to 24 months.
Highlighting the mechanism of action of IND02, Sunil Bhaskaran says,
“In simple terms, this drug converts HIV patients into what
is called in scientific circles as 'HIV Controller' and people can lead
normal lives with the disease, without the regular concerns like costly
treatment or threat to their lives. "He further adds that one in 300
HIV patients is a 'Natural HIV Controller', who is able to block the
progression of the disease by managing the virus and protecting the
immune cells. IND02 is a drug candidate that acts as an 'enabler' that
converts the HIV patient into an HIV controller.
According to the company, since it is a botanical drug, it has got huge
advantages over the NCE drugs and biologicals. The company terms this
drug as the 'third world answer for third world diseases'. This
botanical drug would be affordable with less side-effects as compared
to the anti-retroviral therapy (ART), the current first-line therapy
for AIDS. The company estimates that the drug would cost only a
fraction of ARTs.
Interestingly, the molecule has also shown new indications for the H1N1
strain as well as the H3N2 strain (avian flu). It has also shown to be
effective on Tamiflu-resistant strains. “Since both are
antiviral strains, we were curious to see whether the HIV molecule
could also be a cure for the H1N1 strain and hence started with our
studies in that area,” says Bhaskaran. Separate studies will
be conducted for the H1N1 strain and 330 patients would be recruited
for clinical trials. “We have independently verified the
studies in Japan and biosafety tests were conducted in the National
Taiwan University Hospital in a P3P4 lab,” he adds.
Since the company is aiming at providing affordable drugs for neglected
diseases to the third world countries, officials did not deny the
prospect of approaching organizations like the Bill and Melinda Gates
Foundation who in turn would provide the drugs at a subsidized price.
In addition to the proprietary 'Engine' developed,
Indus has two additional factors that allow its R&D to use a
'lower cost' and
'faster-to-market' approach. First, all potential
drug candidates are isolated from food chain raw materials, thus
minimizing issues related to toxicity on sustained use. The second
factor is that being located in India, Indus Biotech uses the
botanical-friendly regimen conforming to the country's
regulatory requirement by conducting proof-of-concept studies at an
early stage, much before regulatory studies, thus minimizing the risk
of failure at a later stage.
Indus Biotech at present has seven NCEs in the pipeline with HIV/H1N1
(phase III) being the lead molecule. Others include diabetes (completed
proof-of-concept studies and ready for phase III), rheumatoid arthritis
(completed toxicology and proof-of-concept studies), Parkinson's (will
move into human trials in another six months), Huntington's disease (at
pre-clinical stage), kidney disease and depression. The company is also
looking at other segments such as dengue and hepatitis 3.
"IND 02 converts an HIV patient into 'HIV
Controller' and allows for a normal life with disease, free
of concerns like costly treatment or threat to life"
- Sunil Bhaskaran, co-founder and MD, Indus Biotech, Pune
Anand in Bangalore